Judith A Aberg, M.D.

Lower peripheral blood CD14+ monocyte frequency and higher CD34+ progenitor cell frequency are associated with HBV vaccine induced response in HIV infected individuals
Anthony, D D; Umbleja, T; Aberg, J A; Kang, M; Medvik, K; Lederman, M M; Peters, M G; Koziel, M J; Overton, E T
2011 Apr 27;29(19):3558-3563, Vaccine
We evaluated immunologic predictors of response to HBV vaccine administered in the presence or absence of GM-CSF in HIV infected individuals. We measured peripheral blood hematopoietic progenitor, monocyte and myeloid-derived suppressor cell (MDSC) frequencies, and expression of GMCSF receptor on monocytes and MDSCs, at baseline and 4weeks after immunization in relation to antibody response. We observed higher baseline progenitor and lower monocyte frequencies among week 16 antibody responders. Week 4 decline in MDSC frequency was associated with week 16 antibody response, while administration of GM-CSF was associated with preservation of these cells. No significant differences in GM-CSF receptor expression were observed in the presence vs. absence of GM-CSF. These findings are consistent with a positive role of progenitor cells and a potential negative role of monocytes in vaccine response. Additionally, GM-CSF augmented the preservation of peripheral blood MDSC, which may contribute to the lack of improved vaccine responses
— id: 132707, year: 2011, vol: 29, page: 3558, stat: Journal Article,

Global pharmacovigilance for antiretroviral drugs: overcoming contrasting priorities
Bakare, Nyasha; Edwards, Ivor Ralph; Stergachis, Andy; Pal, Shanthi; Holmes, Charles B; Lindquist, Marie; Duncombe, Chris; Dodoo, Alex; Novendstern, Joel; Nwokike, Jude; Kuchenbecker, Ricardo; Aberg, Judith A; Miller, Veronica; Strobos, Jur
2011 Jul;8(7):e1001054-e1001054, PLoS medicine
Jur Strobos and colleagues describe the deliberations of a recent multi-stakeholder meeting discussing the creation of a sustainable global pharmacovigilance system for antiretroviral drugs that would be applicable in resource limited settings
— id: 136652, year: 2011, vol: 8, page: e1001054, stat: Journal Article,

Pharmacokinetics, cord blood concentrations, and tolerability of boosted fosamprenavir in pregnancy
Cespedes M.S.; Ford S.L.; Pakes G.E.; Vargas L.; De Candia E.M.; Aberg J.A.
2011 ;31(10):377e-377e, Pharmacotherapy
PURPOSE: Little is known about the pharmacokinetics of the protease inhibitor fosamprenavir (FPV) in pregnancy and of the concentrations of its active metabolite, amprenavir (APV), that are achieved in infant cord blood. METHODS: A phase I, open-label, single-center study was conducted to evaluate APV pharmacokinetics following twice-daily FPV 700 mg boosted by ritonavir 100 mg in pregnant HIV-infected women. Steady-state PK was assessed in the second and/or third trimesters and at 4-12 weeks postpartum. Maternal serum and cord blood samples were obtained at the time of delivery. Plasma APV concentrations were measured by LC-MS/MS, and PK were determined using WinNonlin. RESULTS: Pharmacokinetic data were obtained from 10 women (5 African-Americans/5 Hispanics; median age 28.6 years). The most common backbone regimen was tenofovir/emtricitabine. FPV was well tolerated, with no hepatic, renal, or adverse events attributed to antiretroviral therapy. At delivery, all women had viral loads <400 c/mL, with 9 undetectable (<50 c/mL). The median (range) AUC (in mug*h/mL), C_max (in mug/mL), and C_12h (in mug/mL) were 26.80 (18.49-40.72), 4.32 (3.07-5.87), and 1.35 (0.88-1.67) during the second trimester (n=6); 32.77 (17.05-66.42), 5.75 (3.26-10.98), and 1.46 (0.66-2.33) during the third trimester (n=9); and 41.73 (28.86-79.66), 6.92 (3.56-9.97), and 2.24 (1.17-5.32) postpartum (n=9). Overall, APV AUC was 22-34% lower, C_max 9-41% lower, and C_12h 27-28% lower during pregnancy than postpartum. Median gestational age of infants was 37.9 weeks, and birth weight was 2909 g. All infants were HIV PCR-negative. No growth abnormalities were observed. Cord blood was obtained from six deliveries; the median ratio of cord blood/maternal APV level was 0.27. CONCLUSION: FPV use during pregnancy was well tolerated. Although APV C_12h was 27-28% lower in pregnancy, HIV was well suppressed for all subjects at delivery. Maternal and cord blood concentrations were above the mean protein binding-adjusted IC50 (0.146 mug/mL) for wild-type virus
— id: 150898, year: 2011, vol: 31, page: 377e, stat: Journal Article,

HIV Counseling and Testing for Household Members of HIV-Infected Individuals in Africa: Should Prevention Programs Focus on Home-Based Rather than Clinic-Based Outreach?
Dallapiazza, Michelle; Aberg, Judith A
2011 Jun;8(2):75-77, Current HIV/AIDS reports
— id: 131962, year: 2011, vol: 8, page: 75, stat: Journal Article,

Virologic Outcome of Using Tenofovir/Emtricitabine to Treat Hepatitis B in HIV-Coinfected Patients
Engell, Christian A; Pham, Vinh Philip; Holzman, Robert S; Aberg, Judith A
2011 ;2011:405390-405390, ISRN gastroenterology
Goal. To study the effect of combination antiviral therapy with tenofovir and emtricitabine or lamivudine with and without prior monotherapy with lamivudine. Study. We reviewed charts of 31 HIV-/HBV-coinfected patients. Twelve 3TC-naive patients initially received tenofovir plus emtricitabine. Nineteen epivir experienced patients who had previously failed epivir were given tenofovir plus emtricitabine. Results. Baseline median HBV DNA was similar in the epivir-naive (5.8x10(7) copies/mL) and experienced group (7.3x10(7) copies/mL, P = .65). The median time to complete suppression of HBV was 466 days in the naive group and 877 days in the experienced (P = .001). After 12 months, 6/10 (60%) naive patients and 3/14 (21%) experienced patients had HBV DNA below the detectionlimit (P = .067). After 24 months, 5/5 (100%) naive patients and 4/13 (31%) experienced patients had an undetectable HBV DNA level (P = .015). Conclusions. The median time to suppression of HBV DNA was significantly shorter among treatment naive patients. There was a significantly greater proportion of naive patients with suppressed HBV DNA at 24 months. Our results support using initial dual therapy in those with HIV/HBV coinfection
— id: 138717, year: 2011, vol: 2011, page: 405390, stat: Journal Article,

High-sensitivity C-reactive protein levels do not decrease with the use of statins in all persons with HIV infection
Fichtenbaum C.J.; Evans S.E.; Aberg J.A.
2011 ;25(16):2053-2053, AIDS
— id: 141086, year: 2011, vol: 25, page: 2053, stat: Journal Article,

Maraviroc can improve lipid profiles in dyslipidemic patients with HIV: results from the MERIT trial
MacInnes, A; Lazzarin, A; Di Perri, G; Sierra-Madero, J G; Aberg, J; Heera, J; Rajicic, N; Goodrich, J; Mayer, H; Valdez, H
2011 Jan-Feb;12(1):24-36, HIV clinical trials
PURPOSE: We investigated the effects of maraviroc, the first approved CC-chemokine receptor 5 (CCR5) antagonist, on blood lipids in a post hoc analysis of the phase 3 MERIT study in treatment-naive patients. METHODS: Patients received maraviroc 300 mg twice daily (n = 360) or efavirenz 600 mg once daily (n = 361), both in combination with zidovudine/lamivudine, for up to 96 weeks. Baseline and on- treatment lipid profiles were analyzed according to National Cholesterol Education Program (NCEP) thresholds. RESULTS: Baseline characteristics and lipid profiles were comparable between groups. Among patients with total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-c) below NCEP treatment thresholds at baseline, significantly more efavirenz- than maraviroc-treated patients exceeded those thresholds at 96 weeks (TC: 35% [74/209] vs 11% [20/188], P < .0001; LDL-c: 23% [47/197] vs 8% [15/183], P < .0001). Among patients exceeding NCEP thresholds at baseline, significantly more efavirenz- than maraviroc-treated patients exceeded the thresholds at 96 weeks (TC: 83% [24/29] vs 50% [17/34], P = .0084; LDL-c: 86% [19/22] vs 55% [16/29], P = .0314). Of those with baseline high- density lipoprotein cholesterol (HDL-c) < 40 mg/dL, 43% (56/130) of maravirocand 62% (86/139) of efavirenz-treated patients achieved HDL-c>/=40 mg/dL at 96 weeks (P = .0020). CONCLUSIONS: Maraviroc was not associated with elevations in TC, LDL-c, or triglycerides and showed beneficial effects on lipid profiles of dyslipidemic patients
— id: 132704, year: 2011, vol: 12, page: 24, stat: Journal Article,

Management of dyslipidemia in HIV-infected patients
Malvestutto, Carlos D.; Aberg, Judith A.
2011 AUG ;6(4):447-462, Clinical Lipidology
Antiretroviral therapy has dramatically increased survival for HIV-infected individuals. As this population lives longer, coronary heart disease has become an important comorbid condition. Dyslipidemia in HIV-infected individuals is a complex condition, with multiple contributing factors including the HIV virus itself, individual genetic characteristics and antiretroviral therapy-induced metabolic changes. Effective management of dyslipidemia in this population is essential to reduce cardiovascular risk but presents multiple challenges due to interactions between antiretroviral therapy agents and lipid-lowering medications
— id: 137813, year: 2011, vol: 6, page: 447, stat: Journal Article,

Substance Use in the Bathhouses: Misuse of Prescription and Sex Enhancing Drugs is On Par with Sexual Behavior as an HIV Risk Factor
McNeely, J.; Silvera, R.; Ramos, M.; Bernstein, K.; Gourevitch, M. N.; Aberg, J.; Daskalakis, D. D.
2011 ;32(1):56-57, Substance abuse
— id: 128811, year: 2011, vol: 32, page: 56, stat: Journal Article,

Awareness of post-exposure HIV prophylaxis in high-risk men who have sex with men in New York City
Mehta, Sapna A; Silvera, Richard; Bernstein, Kyle; Holzman, Robert S; Aberg, Judith A; Daskalakis, Demetre C
2011 Jun;87(4):344-348, Sexually transmitted infections
Objectives To understand the factors associated with knowledge of non-occupational post-exposure prophylaxis (nPEP) and pre-exposure prophylaxis (PrEP), bathhouse patrons in New York City (NYC) were surveyed. Methods 554 men who have sex with men (MSM) at two NYC bathhouses were given a standardised survey focused on nPEP and PrEP at the time of HIV testing. Results In the previous 90 days, 63% of respondents reported unprotected sex with a male partner and 7% reported any sex with a known HIV-positive male partner. Less than half reported having a primary provider (primary care practitioner) who was aware of their MSM behaviour. 201 men (36%) were aware of nPEP or PrEP. In univariate analyses, race/ethnicity, previous HIV testing, gay self-identification, higher education level, having a primary provider aware of MSM behaviour, reported interaction with the healthcare system, use of the internet for meeting sex partners, reporting unprotected sex in the previous 90 days, reporting any sex with an HIV-positive male partner in the previous 90 days and having a higher number of sex partners were each significantly associated with being aware of nPEP or PrEP. In multivariate analysis, having a higher number of sex partners was significantly associated (OR 5.10, p=0.02) with post-exposure prophylaxis (PEP)/PrEP knowledge and disclosure to a primary care provider was also associated, although less robustly (OR 2.10, p=0.06). Conclusions Knowledge of nPEP or PrEP among sexually active MSM in NYC is low and is associated with having a primary provider aware of their patient's same-sex behaviours. These findings show the need for improving education about nPEP among high-risk MSM in NYC and the role of providers in these efforts
— id: 132706, year: 2011, vol: 87, page: 344, stat: Journal Article,

Health Needs of HIV-Infected Women in the United States: Insights from The Women Living Positive Survey
Squires, Kathleen E; Hodder, Sally L; Feinberg, Judith; Bridge, Dawn Averitt; Abrams, Staats; Storfer, Stephen P; Aberg, Judith A
2011 May;25(5):279-285, AIDS patient care & STDs
Abstract The objective of this study was to describe attitudes, opinions, and perceived health needs of HIV-infected women in the United States. In this cross-sectional study, women were invited to participate in the Women Living Positive survey, a structured interview instrument with 45 questions. Collected data were deidentified and the margin of error was calculated as four percentage points. Incoming toll-free phone interviews were conducted from December 21, 2006, through March 14, 2007 among subjects recruited from a U.S. national network of AIDS counseling centers. Seven hundred HIV-infected women (43% African American, 28.5% Hispanic, 28.5% Caucasian; median age, 42.5 years) receiving combination antiretroviral therapy for 3 years or more replied to recruitment flyers. Overall, 55% of survey participants had never discussed gender-specific HIV treatment issues with their HIV care providers. Of the 45% who did discuss these issues, almost all (96%) were satisfied. On average, one-third of the women had seen three or more providers since beginning HIV treatment; 43% indicated they had switched providers because of communication issues. Among women who had been or were pregnant at the time of the survey (n=159), more than half (57%) had not had pre-pregnancy discussions with their HIV provider about the most appropriate HIV regimens for women attempting to become pregnant. Significant communication gaps exist between HIV-infected women and their providers when discussing gender-specific treatment issues. These data highlight a need for U.S. health care providers to incorporate discussion of gender-specific issues, including preconception and reproductive counseling, into management strategies for HIV-infected women
— id: 132705, year: 2011, vol: 25, page: 279, stat: Journal Article,

Cardiac risk: not so simple
Aberg, Judith A; Ribaudo, Heather
2010 Feb 1;201(3):315-317, Journal of infectious diseases
— id: 132712, year: 2010, vol: 201, page: 315, stat: Journal Article,

HIV: primary and secondary prophylaxis for opportunistic infections
Aberg, Judith; Powderly, William
2010 ;2010:?-?, BMJ Clinical evidence
INTRODUCTION: Opportunistic infections can occur in up to 40% of people with HIV infection and a CD4 count less than 250/mm(3), although the risks are much lower with use of highly active antiretroviral treatment. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of prophylaxis for Pneumocystis jirovecii pneumonia (PCP) and toxoplasmosis? What are the effects of antituberculosis prophylaxis in people with HIV infection? What are the effects of prophylaxis for disseminated Mycobacterium avium complex (MAC) disease for people with, and without, previous MAC disease? What are the effects of prophylaxis for cytomegalovirus (CMV), herpes simplex virus (HSV), and varicella zoster virus (VZV)? What are the effects of prophylaxis for invasive fungal disease in people with, and without, previous fungal disease? What are the effects of discontinuing prophylaxis against opportunistic pathogens in people on highly active antiretroviral treatment (HAART)? We searched: Medline, Embase, The Cochrane Library, and other important databases up to March 2008 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). RESULTS: We found 43 systematic reviews, RCTs, or observational studies that met our inclusion criteria. CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: aciclovir; antituberculosis prophylaxis; atovaquone; azithromycin (alone or plus rifabutin); clarithromycin (alone, or plus rifabutin and ethambutol); discontinuing prophylaxis for CMV, MAC, and PCP; ethambutol added to clarithromycin; famciclovir; fluconazole; isoniazid; itraconazole; oral ganciclovir; rifabutin (alone or plus macrolides); trimethoprim-sulfamethoxazole; and valaciclovir
— id: 128802, year: 2010, vol: 2010, page: ?, stat: Journal Article,

REASONS FOR HIV TESTING AMONG MSM ATTENDING A COMMERCIAL SEX VENUE-BASED TESTING PROGRAM IN NEW YORK CITY
Bearnot, B; Silvera, R; Torres, K; Kwan, C; Aberg, J; Daskalakis, D
2010 JUN ;25(9):380-380, Journal of general internal medicine
— id: 111916, year: 2010, vol: 25, page: 380, stat: Journal Article,

Treatment with pravastatin and fenofibrate improves atherogenic lipid profiles but not inflammatory markers in ACTG 5087
Fichtenbaum, Carl J; Yeh, Tzu-Min; Evans, Scott R; Aberg, Judith A
2010 Jul-Aug;4(4):279-287, Journal of Clinical Lipidology
OBJECTIVES: Statins and fibrates alter lipids, apolipoproteins and inflammatory markers in persons without HIV. The objective of this study was to evaluate changes in lipoproteins, apolipoproteins and other markers of inflammation with the use of pravastatin and fenofibrate. DESIGN: Evaluation of participants in ACTG A5087, a randomized trial of pravastatin 40 mg/day or fenofibrate 200 mg/day for the treatment of dyslipidemia. Participants that failed single-agent therapy at week 12 were given the combination. METHODS: Participants with available specimens were tested for apolipoproteins A1 and B, adiponectin, plasminogen-activator inhibitor type 1 (PAI-1), P-selectin, and high-sensitivity C-reactive protein (hs-CRP). RESULTS: 74 participants (37 per randomized arm) received either pravastatin or fenofibrate for 12 weeks with 60 receiving combination treatment from weeks 12-48. There were no significant changes in hs-CRP, PAI-1, and P-selectin. From baseline to week 12, the median Apo B levels (-8 mg/dL, P=0.01 for fenofibrate and -27 mg/dL, P<0.01 for pravastatin) and ApoB/A1 ratios (-0.16, P<0.01 for both arms) significantly decreased. From baseline to week 48, median adiponectin (-1 ng/dL, P<0.01), Apo B (-22 mg/dL, P<0.01) and Apo B/A1 ratios (-0.2, P<0.01) all decreased in those who went on combination therapy, whereas Apo A1 (9.5 mg/dL, P=0.01) levels increased. CONCLUSION: Treatment with pravastatin or fenofibrate improves the atherogenic lipid profile within the first 12 weeks and is sustained through 48 weeks with combination therapy. Adiponectin levels decrease with lipid-lowering therapy. However, markers of inflammation and platelet activation were not appreciably changed suggesting that the biologic properties of these agents differ in persons with HIV infection
— id: 132711, year: 2010, vol: 4, page: 279, stat: Journal Article,

Comparison of once-daily versus twice-daily combination antiretroviral therapy in treatment-naive patients: results of AIDS clinical trials group (ACTG) A5073, a 48-week randomized controlled trial
Flexner, Charles; Tierney, Camlin; Gross, Robert; Andrade, Adriana; Lalama, Christina; Eshleman, Susan H; Aberg, Judith; Sanne, Ian; Parsons, Teresa; Kashuba, Angela; Rosenkranz, Susan L; Kmack, Anne; Ferguson, Elaine; Dehlinger, Marjorie; Mildvan, Donna
2010 Apr 1;50(7):1041-1052, Clinical infectious diseases
BACKGROUND: Dosing frequency is an important determinant of regimen effectiveness. Methods. To compare efficacy of once-daily (QD) versus twice-daily (BID) antiretroviral therapy, we randomized human immunodeficiency virus (HIV)-positive, treatment-naive patients to lopinavir-ritonavir (LPV/r) administered at a dosage of 400 mg of lopinavir and 100 mg of ritonavir BID (n = 160) or 800 mg of lopinavir and 200 mg of ritonavir QD (n = 161), plus either emtricitabine 200 mg QD and extended-release stavudine at a dosage of 100 mg QD or tenofovir at a dosage of 300 mg QD. Randomization was stratified by screening HIV RNA level <100,000 copies/mL versus > or = 100,000 copies/mL. The primary efficacy end point was sustained virologic response (SVR; defined as reaching and maintaining an HIV RNA level <200 copies/mL) through week 48. RESULTS: Subjects were 78% male, 33% Hispanic, and 34% black. A total of 82% of subjects completed the study, and 71% continued to receive the initially assigned dosage schedule. The probability of SVR did not differ significantly for the BID versus QD comparison, with an absolute proportional difference of 0.03 (95% confidence interval [CI], -0.07 to 0.12). The comparison depended on the screening RNA stratum (P=.038); in the higher RNA stratum, the probability of SVR was significantly better in the BID arm than in the QD arm: 0.89 (95% CI, 0.79-0.94) versus 0.76 (95% CI, 0.64-0.84), a difference of 0.13 (95% CI, 0.01-0.25). Lopinavir trough plasma concentrations were higher with BID dosing. Adherence to prescribed doses of LPV/r was 90.6% in the QD arm versus 79.9% in the BID arm (P<.001). Conclusions. Although subjects assigned to QD regimens had better adherence, overall treatment outcomes were similar in the QD and BID arms. Subjects with HIV RNA levels > or =100,000 copies/mL had better SVR with BID regimens at 48 weeks, which suggests a possible advantage in this setting for more frequent dosing. Clinical trial registration. ClinicalTrials.gov registration number: NCT00036452
— id: 132713, year: 2010, vol: 50, page: 1041, stat: Journal Article,

Concerns regarding a randomized study of the timing of antiretroviral therapy in zimbabweans with AIDS and acute cryptococcal meningitis
Grant, Philip M; Aberg, Judith A; Zolopa, Andrew R
2010 Oct 15;51(8):984-985, Clinical infectious diseases
— id: 112561, year: 2010, vol: 51, page: 984, stat: Journal Article,

Development of National and Multiagency HIV Care Quality Measures
Horberg, Michael A; Aberg, Judith A; Cheever, Laura W; Renner, Philip; O'Brien Kaleba, Erin; Asch, Steven M
2010 Sep 15;51(6):732-738, Clinical infectious diseases
Background. Human immunodeficiency virus (HIV) is now a complex, chronic disease requiring high quality care. Demonstration of quality HIV care requires uniform, aligned HIV care quality measurement. Methods. In September 2007, the National Committee for Quality Assurance, under contract with the Health Resources and Services Administration, the Physician Consortium for Performance Improvement of the American Medical Association, and HIV Medicine Association of the Infectious Disease Society of America jointly sponsored and convened an expert panel as a HIV/AIDS Work Group to draft national HIV/AIDS performance measures for individual patient-level and system-level quality improvement. Results. A total of 17 measures were developed to assess processes and outcomes of HIV/AIDS care for patients established in care, defined as having at least 2 visits in a 12-month period; thus, measures of HIV screening, testing, linkage, and access to care were not included. As a set, the measures assess a wide range of care, including patient retention, screening and prophylaxis for opportunistic infections, immunization, and initiation and monitoring of potent antiretroviral therapy. Since development, the HIV/AIDS measures' specifications have been fully determined and are being beta tested, and a majority have been endorsed by the National Quality Forum and have been adopted and implemented by the sponsoring organizations. Conclusions. HIV care quality measurement should be assessed with greater uniformity. The measures presented offer opportunities for such alignment
— id: 111972, year: 2010, vol: 51, page: 732, stat: Journal Article,

Coronary heart disease in people infected with HIV
Malvestutto, Carlos D; Aberg, Judith A
2010 Aug;77(8):547-556, Cleveland Clinic journal of medicine
People infected with human immunodeficiency virus (HIV) are living longer thanks to effective antiretroviral therapy. As this population ages, cardiovascular disease is becoming an important cause of morbidity and death. The authors of this review discuss the magnitude and likely mechanisms of the risk and strategies for managing it
— id: 111548, year: 2010, vol: 77, page: 547, stat: Journal Article,

The virologic and immunologic effects of cyclosporine as an adjunct to antiretroviral therapy in patients treated during acute and early HIV-1 infection
Markowitz, Martin; Vaida, Florin; Hare, C Bradley; Boden, Daniel; Mohri, Hiroshi; Hecht, Frederick M; Kalayjian, Robert C; Conrad, Ann; Mildvan, Donna; Aberg, Judith; Hogan, Christine; Kilby, J Michael; Balfour, Henry H Jr; Schafer, Kim; Richman, Douglas; Little, Susan
2010 May 1;201(9):1298-1302, Journal of infectious diseases
Acute human immunodeficiency virus type 1 (HIV-1) infection is characterized by high levels of immune activation. Immunomodulation with cyclosporine combined with antiretroviral therapy (ART) in the setting of acute and early HIV-1 infection has been reported to result in enhanced immune reconstitution. Fifty-four individuals with acute and early infection were randomized to receive ART with 4 weeks of cyclosporine versus ART alone. In 48 subjects who completed the study, there were no significant differences between treatment arms in levels of proviral DNA or CD4(+) T cell counts. Adjunctive therapy with cyclosporine in this setting does not provide apparent virologic or immunologic benefit
— id: 109817, year: 2010, vol: 201, page: 1298, stat: Journal Article,

Uridine supplementation in the treatment of HIV lipoatrophy: results of ACTG 5229
McComsey, Grace A; Walker, Ulrich A; Budhathoki, Chakra B; Su, Zhaohui; Currier, Judith S; Kosmiski, Lisa; Naini, Linda G; Charles, Stephannie; Medvik, Kathy; Aberg, Judith A
2010 Oct 23;24(16):2507-2515, AIDS
BACKGROUND: Lipoatrophy is prevalent on thymidine nucleoside reverse transcriptase inhibitors (tNRTIs). A pilot trial showed that uridine (NucleomaxX) increased limb fat. METHODS: A5229 was a multicenter trial in which HIV-infected individuals with lipoatrophy on tNRTI regimens were randomized to NucleomaxX or placebo. Primary endpoint was change in limb fat from baseline to week 48. The study was powered to detect 400-g difference between arms at week 48. A stratified Wilcoxon rank-sum test was used to assess between-arm differences. RESULTS: The 165 participants were 91% men, 62% white; median age 49 years, CD4 cell count 506 cells/mul, and limb fat 3037 g; 81% had HIV-1 RNA 50 copies/ml or less; 76% were on zidovudine (ZDV). Baseline characteristics were similar between groups. Only 59% completed 48 weeks of treatment; however, only three participants (one on uridine) discontinued due to toxicity (diarrhea). In intent to treat, there was no difference for changes in limb fat between treatments at week 24 or week 48. On as-treated analysis, uridine resulted in an increase in %limb fat vs. placebo (3.4 vs. -0.8%, P = 0.01) at week 24 but not at week 48 (1.8 vs. 3.8%, P = 0.93). Similar results were seen when limiting the analysis to patients with at least 80% adherence. The results were not related to severity of lipoatrophy or type of tNRTI. No changes were found in facial anthropometrics, fasting lipids, trunk fat, CD4 cell count, or HIV RNA. CONCLUSIONS: We found a modest transient improvement in limb fat after 24 weeks of uridine. The lack of sustained efficacy at week 48 was not due to changes in adherence or reduction in sample size. Uridine was well tolerated and did not impair virologic control
— id: 114878, year: 2010, vol: 24, page: 2507, stat: Journal Article,

CURRENT SUBSTANCE MISUSE AND HIV RISK BEHAVIOR AMONG HIGHLY SEXUALLY ACTIVE MEN WHO HAVE SEX WITH MEN (MSM) ATTENDING COMMERCIAL SEX VENUES, EVENTS AND PARTIES (CSVEP) IN NEW YORK CITY
McNeely, J; Silvera, R; Torres, K; Bernstein, K; Aberg, J; Gourevitch, M; Daskalakis, D
2010 JUN ;25(9):250-250, Journal of general internal medicine
— id: 111910, year: 2010, vol: 25, page: 250, stat: Journal Article,

Metabolic: Week 48 comparison of metabolic parameters and biomarkers in subjects receiving darunavir/ritonavir or atazanavir/ritonavir
Overton T.; Aberg J.A.; Gupta S.; Ryan R.; Baugh B.; De La Rosa G.
2010 ;13:?-?, Journal of the International AIDS Society
Purpose: Protease inhibitors may contribute to metabolic complications and cardiovascular risk associated with HIV infection. Here we investigate metabolic changes following treatment with darunavir/ritonavir (DRV/r)- compared with atazanavir/ritonavir (ATV/r)-based therapy. Methods: In this 48-week, Phase IV, multicenter, open-label, randomized, exploratory study, HIV-1-infected, antiretroviral nave adults were given DRV/r 800/100mg once daily (qd) or ATV/r 300/100mg qd, both with tenofovir/ emtricitabine 300/200mg qd. Week 48 changes in fasting lipids, glucose, insulin, insulin sensitivity, creatinine clearance, biomarkers (inflammation, coagulation and bacterial translocation), CD4 count, viral load (VL) and safety are reported. Observed values and descriptive statistics are reported through Week 48 for intent-to-treat and lipid evaluable populations. Results 34 (median age, 37 years; men, n=29) and 31 (median age, 35 years; men, n=27) subjects were randomized to the DRV/r arm and ATV/r arm, respectively. Of these, 29 DRV/r and 25 ATV/r subjects completed Week 48. At Week 48, changes in fasting lipids and biomarkers were similar between arms. Although rates of adverse events (AEs) and laboratory abnormalities were comparable between arms, ATV/r arm had higher rates of grade 2-4 hyperbilirubinemia (n=27 [87%] vs n=1 [3%]). At Week 48, 77% of DRV/r and 71% of ATV/r subjects had VL <50 copies/mL (confirmed virologic response). Table 1. Conclusions: Changes from baseline to Week 48 in fasting lipids, glucose, insulin, HOMA-IR, creatinine clearance, biomarkers, CD4 and VL were similar for DRV/r and ATV/r. Given its favorable metabolic profile, which was maintained over 48 weeks, DRV/r provides a valuable therapeutic option for HIV-1-infected subjects
— id: 114622, year: 2010, vol: 13, page: ?, stat: Journal Article,

Immune response to hepatitis B vaccine in HIV-infected subjects using granulocyte-macrophage colony-stimulating factor (GM-CSF) as a vaccine adjuvant: ACTG study 5220
Overton, E T; Kang, M; Peters, M G; Umbleja, T; Alston-Smith, B L; Bastow, B; Demarco-Shaw, D; Koziel, M J; Mong-Kryspin, L; Sprenger, H L; Yu, J Y; Aberg, J A
2010 Aug 2;28(34):5597-5604, Vaccine
HIV-infected persons are at risk for HBV co-infection which is associated with increased morbidity and mortality. Unfortunately, protective immunity following HBV vaccination in HIV-infected persons is poor. This randomized, phase II, open-label study aimed to evaluate efficacy and safety of 40 mcg HBV vaccine with or without 250 mcg GM-CSF administered at day 0, weeks 4 and 12. HIV-infected individuals >or=18 years of age, CD4 count >or=200 cells/mm(3), seronegative for HBV and HCV, and naive to HBV vaccination were eligible. Primary endpoints were quantitative HBsAb titers and adverse events. The study enrolled 48 subjects. Median age and baseline CD4 were 41 years and 446 cells/mm(3), 37 were on ART, and 26 subjects had undetectable VL. Vaccination was well tolerated. Seven subjects in the GM-CSF arm reported transient grade >or=2 signs/symptoms (six grade 2, one grade 3), mostly aches and nausea. GM-CSF had no significant effect on VL or CD4. Four weeks after vaccination, 26 subjects (59%) developed a protective antibody response (HBsAb >or=10 mIU/mL; 52% in the GM-CSF arm and 65% in the control arm) without improved Ab titer in the GM-CSF vs. control arm (median 11 mIU/mL vs. 92 mIU/mL, respectively). Response was more frequent in those with CD4 >or=350 cells/mm(3) (64%) than with CD4 <350 cells/mm(3) (50%), though not statistically significant. GM-CSF as an adjuvant did not improve the Ab titer or the development of protective immunity to HBV vaccination in those receiving an accelerated vaccine schedule. Given the common routes of transmission for HIV and HBV, additional HBV vaccine research is warranted
— id: 132709, year: 2010, vol: 28, page: 5597, stat: Journal Article,

Letter in response to the new SHEA guideline for healthcare workers with hepatitis B virus, hepatitis C virus, and/or human immunodeficiency virus
Saag, Michael S; Squires, Kathleen E; Aberg, Judith A; Bardeguez, Arlene
2010 Oct;31(10):1092-1093, Infection control & hospital epidemiology
— id: 132708, year: 2010, vol: 31, page: 1092, stat: Journal Article,

METABOLIK (Metabolic Evaluation in Treatment-naives Assessing the impact of two Boosted protease inhibitors on Lipids and other markers): week 48 comparison of body fat changes in ARV-naive subjects receiving darunavir/ritonavir- or atazanavir/ritonavir-based therapy
Tebas, P.; Sax, P.; Aberg, J.; Gupta, S.; Overton, T.; Ryan, R.; De La Rosa, G.
2010 FEB 28 ;15(8):A39-A40, Antiviral therapy
— id: 128838, year: 2010, vol: 15, page: A39, stat: Journal Article,

Antiretroviral treatment of adult HIV infection: 2010 recommendations of the International AIDS Society-USA panel
Thompson, Melanie A; Aberg, Judith A; Cahn, Pedro; Montaner, Julio S G; Rizzardini, Giuliano; Telenti, Amalio; Gatell, Jose M; Gunthard, Huldrych F; Hammer, Scott M; Hirsch, Martin S; Jacobsen, Donna M; Reiss, Peter; Richman, Douglas D; Volberding, Paul A; Yeni, Patrick; Schooley, Robert T
2010 Jul 21;304(3):321-333, JAMA
CONTEXT: Recent data regarding the consequences of untreated human immunodeficiency virus (HIV) infection and the expansion of treatment choices for antiretroviral-naive and antiretroviral-experienced patients warrant an update of the International AIDS Society-USA guidelines for the use of antiretroviral therapy in adults with HIV infection. OBJECTIVES: To provide updated recommendations for management of HIV-infected adults, using antiretroviral drugs and laboratory monitoring tools available in the international, developed-world setting. This report provides guidelines for when to initiate antiretroviral therapy, selection of appropriate initial regimens, patient monitoring, when to change therapy, and what regimens to use when changing. DATA SOURCES AND STUDY SELECTION: A panel with expertise in HIV research and clinical care reviewed relevant data published or presented at selected scientific conferences since the last panel report through April 2010. Data were identified through a PubMed search, review of scientific conference abstracts, and requests to antiretroviral drug manufacturers for updated clinical trials and adverse event data. DATA EXTRACTION AND SYNTHESIS: New evidence was reviewed by the panel. Recommendations were drafted by section writing committees and reviewed and edited by the entire panel. The quality and strength of the evidence were rated and recommendations were made by full panel consensus. CONCLUSIONS: Patient readiness for treatment should be confirmed before initiation of antiretroviral treatment. Therapy is recommended for asymptomatic patients with a CD4 cell count < or = 500/microL, for all symptomatic patients, and those with specific conditions and comorbidities. Therapy should be considered for asymptomatic patients with CD4 cell count > 500/microL. Components of the initial and subsequent regimens must be individualized, particularly in the context of concurrent conditions. Patients receiving antiretroviral treatment should be monitored regularly; treatment failure should be detected and managed early, with the goal of therapy, even in heavily pretreated patients, being HIV-1 RNA suppression below commercially available assay quantification limits
— id: 132710, year: 2010, vol: 304, page: 321, stat: Journal Article,

A pilot study to determine the impact on dyslipidemia of adding tenofovir to stable background antiretroviral therapy: ACTG 5206
Tungsiripat, Marisa; Kitch, Douglas; Glesby, Marshall J; Gupta, Samir K; Mellors, John W; Moran, Laura; Jones, Lynne; Alston-Smith, Beverly; Rooney, James F; Aberg, Judith A
2010 Jul 17;24(11):1781-1784, AIDS
Several studies have reported improvement in lipids after antiretroviral therapy switches to tenofovir disoproxil fumarate (TDF)-containing regimens. We assessed lipid-lowering effects of TDF by adding it to a stable antiretroviral therapy regimen in this double-blind, placebo-controlled crossover study. We demonstrated that nonhigh-density lipoprotein cholesterol, low-density lipoprotein cholestrol, and total cholestrol improved significantly over TDF vs. placebo treatment in HIV-infected individuals with dyslipidemia. Adding TDF to stable, virologically suppressive antiretroviral therapy regimens improved lipid parameters, supporting a lipid-lowering effect of TDF
— id: 138183, year: 2010, vol: 24, page: 1781, stat: Journal Article,

Cardiovascular complications in HIV management: past, present, and future
Aberg, Judith A
2009 Jan 1;50(1):54-64, Journal of acquired immune deficiency syndromes. JAIDS
Highly active antiretroviral therapy (HAART) has significantly improved the prognosis for many individuals with HIV infection. Consequently, HIV infection has become a chronic and manageable disease. The focus on long-term management of patients with HIV infection has broadened to include comorbid conditions, most notably cardiovascular disease. Patients with HIV infection share many cardiovascular risk factors with the general population, and HIV infection itself may increase cardiovascular risk. Changes in lipid profiles associated with increased cardiovascular risk that have been observed with some HAART regimens have been a cause for concern among clinicians who treat HIV-infected patients. However, the lipid effects of HAART seem to depend on the type and duration of regimens employed. They can be managed effectively according to current guidelines that recommend lifestyle changes (eg, improved diet, increased exercise, smoking cessation) and pharmacologic therapy described in established treatment paradigms for patients on antiretroviral therapy and similar to measures currently used by the general population. A review of the clinical data indicates that the virologic and immunologic benefits of HAART clearly outweigh any metabolic effects observed in some patients over time and that preexisting, established cardiovascular risk factors contribute significantly to the potential development of cardiovascular events. These benefits of antiretroviral therapy have been demonstrated in studies comparing the superior efficacy of continuous vs. intermittent HAART
— id: 97840, year: 2009, vol: 50, page: 54, stat: Journal Article,

Lipid management in patients who have HIV and are receiving HIV therapy
Aberg, Judith A
2009 Mar;38(1):207-222, Endocrinology & metabolism clinics of North America
Dyslipidemia now is recognized as a significant potential adverse event in HIV-infected patients who are receiving antiretroviral therapy. HIV-infected persons who have hyperlipidemia should be managed similarly to those without HIV infection in accordance with the National Cholesterol Education Program. Providers must treat the HIV infection first; if dyslipidemia develops, patients should be prescribed lipid-lowering therapies or should consider modifying their current antiretroviral therapy, if indicated. Evidence for these two strategies is discussed
— id: 93866, year: 2009, vol: 38, page: 207, stat: Journal Article,

Primary care guidelines for the management of persons infected with human immunodeficiency virus: 2009 update by the HIV medicine association of the infectious diseases society of America
Aberg, Judith A; Kaplan, Jonathan E; Libman, Howard; Emmanuel, Patricia; Anderson, Jean R; Stone, Valerie E; Oleske, James M; Currier, Judith S; Gallant, Joel E
2009 Sep 1;49(5):651-681, Clinical infectious diseases
Evidence-based guidelines for the management of persons infected with human immunodeficiency virus (HIV) were prepared by an expert panel of the HIV Medicine Association of the Infectious Diseases Society of America. These updated guidelines replace those published in 2004. The guidelines are intended for use by health care providers who care for HIV-infected patients or patients who may be at risk for acquiring HIV infection. Since 2004, new antiretroviral drugs and classes have become available, and the prognosis of persons with HIV infection continues to improve. However, with fewer complications and increased survival, HIV-infected persons are increasingly developing common health problems that also affect the general population. Some of these conditions may be related to HIV infection itself and its treatment. HIV-infected persons should be managed and monitored for all relevant age- and gender-specific health problems. New information based on publications from the period 2003-2008 has been incorporated into this document
— id: 101322, year: 2009, vol: 49, page: 651, stat: Journal Article,

Implementation of HIV testing at 2 New York City bathhouses: from pilot to clinical service
Daskalakis, Demetre; Silvera, Richard; Bernstein, Kyle; Stein, Dylan; Hagerty, Robert; Hutt, Richard; Maillard, Alith; Borkowsky, William; Aberg, Judith; Valentine, Fred; Marmor, Michael
2009 Jun 1;48(11):1609-1616, Clinical infectious diseases
BACKGROUND: Commercial sex venues (e.g., bathhouses) that cater to men who have sex with men (MSM) continue to function in most urban areas. These venues present a challenge to developing strategies to prevent the spread of the human immunodeficiency virus (HIV), but they also provide opportunities for interventions to reduce the risk and rate of disease transmission. Several cities in the United States have developed programs that offer HIV testing in these venues. Similar programs have not existed before in New York City. METHODS: A pilot HIV testing program was implemented at 2 New York City bathhouses. Testing included rapid HIV testing, the use of the serologic testing algorithm for recent HIV seroconversion, and pooled plasma HIV viral load to detect and date incident and acute HIV infections. In addition to HIV tests, behavioral and demographic data were collected from 493 presumed HIV-negative participants. RESULTS: The pilot program recruited MSM who were at high risk for HIV infection. Of the 493 men tested, 20 (4%) were found to be positive for HIV, and 8 (40%) of these 20 men demonstrated evidence of acute or recent HIV infection. The program tested men often not tested in more traditional medical settings. Significant disparities were demonstrated in the testing habits of MSM who reported having sex with women and had not disclosed same-sex activities to their caregivers. CONCLUSIONS: Bathhouse-based testing for HIV infection can be implemented in New York City and would include a population of MSM who are at high risk for HIV infection. Because of the high rate of recent HIV infection, expanded testing in these venues may be a good strategy to reduce the forward transmission of HIV in this highly sexually active population
— id: 98009, year: 2009, vol: 48, page: 1609, stat: Journal Article,

HIV policy: the path forward--a joint position paper of the HIV Medicine Association of the Infectious Diseases Society of America and the American College of Physicians
Lubinski, Christine; Aberg, Judith; Bardeguez, Arlene D; Elion, Richard; Emmanuel, Patricia; Kuritzkes, Daniel; Saag, Michael; Squires, Kathleen E; Weddle, Andrea; Rainey, Jennifer; Zerehi, M Renee; Ralston, J Fred; Fleming, David A; Bronson, David; Cooke, Molly; Cutler, Charles; Ejnes, Yul; Gluckman, Robert; Liebow, Mark; Musana, Kenneth; Mayer, Mark E; Purtle, Mark W; Reynolds, P Preston; Viswanathan, Lavanya; Weiss, Kevin B; Yehia, Baligh
2009 May 15;48(10):1335-1344, Clinical infectious diseases
— id: 106041, year: 2009, vol: 48, page: 1335, stat: Journal Article,

New goals for viral suppression in HIV treatment in even the most experienced of patients
Sterling S.A.; Aberg J.A.
2009 ;6(2):51-52, Current HIV/AIDS reports
— id: 99001, year: 2009, vol: 6, page: 51, stat: Journal Article,

Lymphoma diagnosis and plasma Epstein-Barr virus load during vicriviroc therapy: results of the AIDS Clinical Trials Group A5211
Tsibris, Athe M N; Paredes, Roger; Chadburn, Amy; Su, Zhaohui; Henrich, Timothy J; Krambrink, Amy; Hughes, Michael D; Aberg, Judith A; Currier, Judith S; Tashima, Karen; Godfrey, Catherine; Greaves, Wayne; Flexner, Charles; Skolnik, Paul R; Wilkin, Timothy J; Gulick, Roy M; Kuritzkes, Daniel R
2009 Mar 1;48(5):642-649, Clinical infectious diseases
BACKGROUND: Lack of functional CCR5 increases the severity of certain viral infections, including West Nile virus and tickborne encephalitis. In a phase II trial of the investigational CCR5 antagonist vicriviroc (AIDS Clinical Trials Group protocol A5211), 4 lymphomas occurred in study patients who received vicriviroc. Because of the known association between unregulated Epstein-Barr virus (EBV) replication and lymphoma in immunocompromised patients, we evaluated whether vicriviroc exposure was associated with lymphoma EBV antigen positivity and/or had an effect on plasma levels of EBV DNA. METHODS: Clinical findings for all 4 patients enrolled in the A5211 study who developed lymphoma (2 Hodgkin and 2 non-Hodgkin) were reviewed, and tumor specimens were assessed for evidence of ongoing EBV replication. Longitudinal plasma samples from 116 patients in the A5211 study were analyzed, and EBV DNA was quantified by real-time polymerase chain reaction. RESULTS: Plasma EBV DNA was not detected in the 2 patients with non-Hodgkin lymphoma; both patients with Hodgkin lymphoma who had samples tested had EBV DNA levels <3200 copies/mL. One patient with Hodgkin lymphoma had a lymph node core biopsy specimen that was strongly positive for EBV; the other 3 lymphomas were histochemically EBV negative. None of the 116 patients with available samples experienced sustained increases in plasma EBV levels. CONCLUSIONS: CCR5 antagonism by vicriviroc treatment in treatment-experienced patients was not associated with reactivation of EBV infection
— id: 93867, year: 2009, vol: 48, page: 642, stat: Journal Article,

Prophylaxis of opportunistic infections in HIV infection
Aberg JA
Clinical infectious disease New York : Cambridge University Press, 2008,
— id: 5270, year: 2008, vol: , page: 721, stat: Chapter,

Drug-drug interactions with newer antiretroviral agents
Aberg, Judith A
2008 Dec;16(5):146-150, Topics in HIV medicine
Knowledge of drug interactions among antiretroviral agents and other drugs used by HIV-infected patients is essential to maintaining safety and efficacy of drug treatment. Often, the clinical impact of drug-drug interactions cannot be predicted on the basis of pharmacokinetic interactions alone, highlighting the need for studies and analyses that provide exposure-response data. Drug interactions in HIV-infected patients can be complex and sometimes counterintuitive, and practitioners must increasingly rely on a concerted approach to gathering information on drug interactions that goes beyond studies showing exposure changes for coadministered drugs
— id: 92688, year: 2008, vol: 16, page: 146, stat: Journal Article,

Fish oil and fenofibrate for the treatment of hypertriglyceridemia in HIV-infected subjects on antiretroviral therapy: results of ACTG A5186
Gerber, John G; Kitch, Douglas W; Fichtenbaum, Carl J; Zackin, Robert A; Charles, Stephannie; Hogg, Evelyn; Acosta, Edward P; Connick, Elizabeth; Wohl, David; Kojic, E Milu; Benson, Constance A; Aberg, Judith A
2008 Apr 1;47(4):459-466, Journal of acquired immune deficiency syndromes. JAIDS
INTRODUCTION: Fish oil has been shown to reduce serum triglyceride (TG) concentrations. In HIV-infected patients on antiretroviral therapy, high TG concentrations likely contribute to increased risk of cardiovascular disease. AIDS Clinical Trials Group A5186 examined the safety and efficacy of fish oil plus fenofibrate in subjects not achieving serum TG levels < or =200 mg/dL with either agent alone. METHODS: One hundred subjects on highly active antiretroviral therapy with serum TG concentrations > or =400 mg/dL and low-density lipoprotein cholesterol < or =160 mg/dL were randomized to 3 g of fish oil twice daily or 160 mg of fenofibrate daily for 8 weeks. Subjects with a fasting TG level >200 mg/dL at week 8 received a combination of fish oil and fenofibrate in the same doses from week 10 to week 18. RESULTS: Median baseline TG was 662 mg/dL in the fish oil group and 694 mg/dL in the fenofibrate group (P = not significant). Fish oil reduced TG levels by a median of 283 mg/dL (46%), fenofibrate reduced them by 367 mg/dL (58%), and combination therapy reduced them by 65.5%. Combination therapy achieved TG levels of < or =200 mg/dL in 22.7% subjects. Fish oil had no measurable effect on immunologic parameters or the pharmacokinetics of lopinavir. CONCLUSIONS: Fish oil was safe when administered alone or combined with fenofibrate and significantly reduced TG levels in HIV-infected subjects with hypertriglyceridemia
— id: 78644, year: 2008, vol: 47, page: 459, stat: Journal Article,

Clinical impact of patient population differences and genomic variation in efavirenz therapy
King, Jennifer; Aberg, Judith A
2008 Sep 12;22(14):1709-1717, AIDS
Guidelines for use of antiretroviral agents presently recommend first-line treatments with nonnucleoside reverse transcriptase inhibitor-based regimens. Efavirenz is the standard-of-care comparator for nonnucleoside reverse transcriptase inhibitor-based antiretroviral therapy. As with many antiretroviral medications, efavirenz is subject to interindividual variation in metabolism, effectiveness, and tolerability. Demographic factors such as age, sex, and ethnicity have been demonstrated to influence this variability, but other underlying factors such as genetics, disease state, and concomitant drug use can also play a role. The clinical impactions of these factors are only beginning to be understood. Although significant advances have led to a greater understanding of interactions between genetic and host factors that influence the efficacy and toxicity of efavirenz, providers should not withhold treatment of HIV infection with an efavirenz-based regimen on the basis of racial or ethic categorizations
— id: 93868, year: 2008, vol: 22, page: 1709, stat: Journal Article,

Prevalence and Significance of G6PD Deficiency in Patients of an Urban HIV Clinic
Tungsiripat, Marisa; Drechsler, Henning; Sarlone, Christine; Amyot, Kathleen; Laffey, Elizabeth; Aberg, Judith
2008 Jun;7(2):88-90, Journal of the International Association of Physicians in AIDS Care : JIAPAC
The rationale to screen for glucose-6-phosphate dehydrogenase (G6PD) deficiency in HIV-infected individuals is their increased likelihood to receive oxidant drugs and subsequent potential of hemolytic events. However, current guidelines regarding who should be screened are conflicting. The authors examined the prevalence of G6PD deficiency and the frequency of hemolytic events in an urban HIV clinic. They used data from a military database as a comparison. In both cohorts, a relatively high number of black females were found to be G6PD deficient (10% and 13%), which was similar to the rate in men (15% and 12%). No white females were G6PD deficient. The authors identified 8 drug-related hemolytic events in HIV clinic patients. Two patients necessitated blood transfusions; both were triggered by trimethoprim/sulfamethoxazole (TMP/SMX). Although G6PD screening prior to the use of TMP/SMX is not often considered by clinicians, the authors' finding of 2 hemolytic events requiring transfusion suggests this would be beneficial
— id: 78642, year: 2008, vol: 7, page: 88, stat: Journal Article,

Low bone mineral density: HIV related?
Aberg JA; McComsey G
2007 ;15(3):139-140, Infectious diseases in clinical practice
— id: 72779, year: 2007, vol: 15, page: 139, stat: Journal Article,

Pafuramidine for Pneumocystis jiroveci pneumonia in HIV-infected individuals
Chen, Donald; Marsh, Rebecca; Aberg, Judith A
2007 Dec;5(6):921-928, Expert review of anti-infective therapy
Pneumocystis jiroveci pneumonia remains one of the major worldwide contributors to the morbidity and mortality of those with HIV infection. The mainstay of therapy for treatment is trimethoprim-sulfamethoxazole (TMP-SMX); however TMP-SMX may be associated with significant side effects and intolerability. In addition, TMP-SMX has a moderate pill burden with three- to four-times daily dosing schedule. Patients unable to tolerate TMP-SMX are confronted with either parenteral therapy or other oral agents that may be less efficacious or are associated with potential serious adverse reactions. Pafuramidine (DB289) is an orally bioavailable prodrug of furamidine (DB75), an investigational diamidine that is less toxic than previous diamidines such as pentamidine. To date, human trials suggest that pafuramidine is well tolerated overall and has clinical activity against Pneumocystis pneumonia. In this article, we review the available data for the use of pafuramidine in Pneumocystis pneumonia
— id: 78643, year: 2007, vol: 5, page: 921, stat: Journal Article,

Comparison of direct and indirect measurement of LDL-C in HIV-infected individuals: ACTG 5087
Evans, Scott R; Fichtenbaum, Carl J; Aberg, Judith A
2007 Jan-Feb;8(1):45-52, HIV clinical trials
BACKGROUND: Hypertriglyceridemia is common in HIV-infected individuals on antiretroviral therapy. Triglyceride (TG) levels >400 mg/dL interfere with the accurate determination of low-density lipoproteins (LDL-C) by the Friedewald equation, making it difficult to assess coronary heart disease risk. OBJECTIVE: The objective of this study is to compare the agreement of the direct LDL-C assay and the Friedewald equation with a reference ultracentrifugation method in the estimation of LDL-C concentrations. METHOD: Samples from ACTG 5087 were assayed by ultracentrifugation and a direct enzymatic assay and calculated using the Friedewald equation. RESULTS: In subjects with TG <400 mg/dL (n = 271), 90% of the direct LDL-C values and Friedewald calculations were within 30 mg/dL and 32 mg/dL of the ultracentrifugation values, respectively. With TG > or = 400 mg/dL (n = 186), 90% of the direct assay and Friedewald observations were within 68 mg/dL and 120 mg/dL of the ultracentrifugation results, respectively. Only 27% of the LDL-C values were within 15 mg/dL of the ultracentrifugation LDL-C results for direct assay and 16.3% for the Friedewald equation. CONCLUSION: The direct LDL-C assay and the calculated LDL-C values did not display adequate agreement with the reference ultracentrifugation method. In subjects with TG >400 mg/dL, the direct assay overestimates the actual LDL-C whereas the Friedewald calculation underestimates the actual LDL. Clinical usage of these methods may lead to misclassification of the severity of dyslipidemia, resulting in improper management
— id: 78645, year: 2007, vol: 8, page: 45, stat: Journal Article,

Protease inhibitor-based antiretroviral therapy and glucose tolerance in pregnancy: AIDS Clinical Trials Group A5084
Hitti, Jane; Andersen, Janet; McComsey, Grace; Liu, Tun; Melvin, Ann; Smith, Laura; Stek, Alice; Aberg, Judith; Hull, Andrew; Alston-Smith, Beverly; Watts, D Heather; Livingston, Elizabeth
2007 Apr;196(4):331.e1-331.e7, American journal of obstetrics & gynecology
OBJECTIVE: The objective of the study was to determine whether protease inhibitors increase glucose intolerance and insulin resistance in pregnancy. STUDY DESIGN: In this multicenter, prospective, observational study, 149 human immunodeficiency virus-1-infected pregnant women had fasting insulin, glucose, and C-peptide measured followed by a 1 hour, 50 g glucose test. Glucose intolerance was defined as a 1 hour glucose greater than 130 mg/dL. Glucose intolerance, homeostasis model assessment of insulin resistance and pancreatic beta-cell function, and pregnancy outcomes were compared between those taking protease inhibitors and those not. RESULTS: Fifty-seven of 149 subjects (38%) had glucose intolerance. Body mass index, Hispanic ethnicity, and maternal age, but not protease inhibitors, were associated with glucose intolerance. There were no differences in insulin resistance, beta-cell function, or pregnancy outcome associated with protease inhibitor use. CONCLUSIONS: Protease inhibitors do not increase risk of glucose intolerance or insulin resistance among pregnant women
— id: 71783, year: 2007, vol: 196, page: 331.e1, stat: Journal Article,

Safety and tolerability of sequential pegylated IFN-alpha2a and tenofovir for hepatitis B infection in HIV(+) individuals
Johnson, R M; Ristig, M B; Overton, E T; Lisker-Melman, M; Cummings, O W; Aberg, J A
2007 May-Jun;8(3):173-181, HIV clinical trials
Chronic hepatitis B virus infections are a major cause of morbidity and mortality in HIV co-infected patients. The standard of care for treating HCV co-infection has been guided by major clinical trials, but the treatment of HBV co-infection has not been as thoroughly studied and the standard of care remains largely untested. The single pill formulation of tenofovir with emtricitabine has become a standard treatment approach in HBV co-infected patients. WU114 was a phase 1 clinical trial that examined the safety and tolerability of sequential treatment of HBV with pegylated interferon-alpha2a plus delayed-initiation tenofovir in HIV co-infected individuals. We postulated that initial HBV viral load reduction with pegylated interferon prior to initiation of nucleoside/nucleotide therapy would increase seroconversion events and durability of HBV virologic suppression. No severe pegylated IFN-alpha2a drug toxicities were seen in either the monotherapy or delayed tenofovir arms. Sequential pegylated interferon and tenofovir-based therapy was tolerable and should be compared with dual nucleoside/nucleotide suppression to determine relative frequencies of seroconversion and durability of HBV suppression in co-infected patients
— id: 78646, year: 2007, vol: 8, page: 173, stat: Journal Article,

Discontinuation of antiretroviral therapy postpartum: no evidence for altered viral set point
Tungsiripat, Marisa; Drechsler, Henning; Aberg, Judith A
2007 Jan 1;44(1):116-117, Journal of acquired immune deficiency syndromes. JAIDS
— id: 71784, year: 2007, vol: 44, page: 116, stat: Journal Article,

Infectious diseases handbook : including antimicrobial therapy & diagnostic tests/procedures
Aberg, Judith A
Hudson OH : Lexi-Comp, 2006,
— id: 2160, year: 2006, vol: , page: , stat: ,

Management of dyslipidemia and other cardiovascular risk factors in HIV-infected patients: case-based review
Aberg, Judith A
2006 Oct-Nov;14(4):134-139, Topics in HIV medicine
Many HIV-infected patients have dyslipidemia and other cardiovascular risk factors prior to acquiring infection. Both HIV infection itself and antiretroviral therapy can cause or worsen lipid abnormalities. Management of dyslipidemia in the HIV-infected patient requires awareness of the effects of antiretroviral agents on lipid profiles, including potential sex- and race-related effects, and interactions between lipid-modifying agents and antiretroviral agents. This article uses individual case histories to illustrate the decisions encountered in treating HIV infection and dyslipidemia. The article is based on a presentation on management of dyslipidemia and other cardiovascular risk factors in HIV infection made by Judith A. Aberg, MD, at the International AIDS Society-USA Los Angeles CME program in February 2006
— id: 69700, year: 2006, vol: 14, page: 134, stat: Journal Article,

The changing face of HIV care: common things really are common
Aberg, Judith A
2006 Sep 19;145(6):463-465, Annals of internal medicine
— id: 68684, year: 2006, vol: 145, page: 463, stat: Journal Article,

Pharmacokinetic interaction between nelfinavir and pravastatin in HIV-seronegative volunteers: ACTG Study A5108
Aberg, Judith A; Rosenkranz, Susan L; Fichtenbaum, Carl J; Alston, Beverly L; Brobst, Susan W; Segal, Yoninah; Gerber, John G
2006 Mar 21;20(5):725-729, AIDS
BACKGROUND: Nelfinavir, an HIV protease inhibitor with numerous drug-drug interactions, is associated with dyslipidemia. Pravastatin is the preferred statin prescribed for HIV-associated dyslipidemia. OBJECTIVE: To examine the effect of nelfinavir on pravastatin pharmacokinetics. DESIGN: Open-label study in healthy HIV-seronegative adults conducted at the AIDS Clinical Trials Group sites in the United States. METHODS: Subjects received pravastatin 40 mg daily and underwent intensive sampling for pharmacokinetics on day 3. Subjects took only nelfinavir 1250 mg twice daily on days 4-12. On days 13-15, subjects continued nelfinavir and reinitiated pravastatin. Plasma samples were collected over 24 h for the calculation of pravastatin area under the concentration-time curve for 0-24 h on days 3 and 16. RESULTS: Data from 14 subjects with complete pharmacokinetic samples were available for analysis. The median within-subject percentage change in pravastatin AUC was a decrease of 46.5%. Pravastatin maximum plasma concentrations were also lower when pravastatin was administered with nelfinavir. Median values for the maximum plasma concentrations were 27.9 and 12.4 ng/ml for days 3 and 16, respectively, and the median within-subject decrease was 40.1%. CONCLUSIONS: Coadministration of pravastatin and nelfinavir led to a substantial reduction in pravastatin plasma concentrations. Higher doses of pravastatin may need to be prescribed in order to achieve optimal lipid-lowering activity
— id: 68687, year: 2006, vol: 20, page: 725, stat: Journal Article,

Clinical research in the lay press: irresponsible journalism raises a huge dose of doubt
Anaissie, Elias J; Segal, Brahm H; Graybill, John R; Arndt, Carola; Perfect, John R; Kleinberg, Michael; Pappas, Peter; Benjamin, Danny; Rubin, Robert; Aberg, Judith A; Adderson, Elisabeth E; Adler-Shohet, Felice C; Akan, Hamdi; Akova, Murat; Almyroudis, Nikolaos G; Alexander, Barbara D; Andes, David; Arrieta, Antonio; Baddley, John W; Barron, Michelle A; Belzberg, Howard; Boucher, Helen W; Boyce, Thomas G; Casadevall, Arturo; Chandrasekar, P H; Cleary, John D; Cordonnier, Catherine; Cornely, Oliver A; Cuenca-Estrella, Manuel; Daly, Jennifer S; Daoura, Nicholas; Denning, David W; dePauw, Ben; de Repentigny, Louis; Dignani, Maria Cecilia; Dismukes, William E; Donnelly, J Peter; Donowitz, Gerald R; Dupont, Bertrand; Drusano, George; Ellis, Michael; Espinel-Ingroff, Ana; Fishman, Jay A; Fleming, Rhonda; Forrest, Graeme; Ghannoum, Mahmoud; Goldman, Mitchell; Grazziutti, Monica; Greene, John N; Greenberg, Richard N; Gubbins, Paul O; Hadley, Susan; Herbrecht, Raoul; Hiemenz, John W; Hope, William; Hospenthal, Durane R; Husain, Shahid; Ito, James I; Jacobson, Robert M; Johnson, Melissa; Keating, Michael R; Kett, Daniel H; Knapp, Katherine; Kontoyiannis, Dimitrios P; Krcmery, Vladimir C; Larsen, Robert; Laverdiere, Michel; Ljungman, Per; Lortholary, O; Maertens, Johan; Marriott, Debbie; Mattiuzzi, Gloria; McGinnis, Michael R; Morris, Michele; Nucci, Marcio; Odds, Frank C; Pankey, George A; Patterson, Thomas; Pfaller, Mike; Razonable, Raymond R; Reboli, Annette C; Rinaldi, Michael G; Roberts, Glenn D; Rodriguez Tudela, Juan Luis; Rotstein, Coleman; Ruhnke, Markus; Schuster, Mindy; Shoham, Shmuel; Sia, Irene G; Siebel, Nita; Silviera, Fernanda; Singh, Nina; Sobel, Jack; Solomkin, Joseph S; Sorrell, Tania C; Steinbach, William J; Temesgen, Zelalem; Tortorano, AnnaMaria; Vartivarian, Shahe; VerWeij, Paul; Viscoli, Claudio; Viviani, Maria Anna; Walker, Randall C; Wheat, Joseph L; Wiley, Joseph; Williamson, Peter; Wingard, John R; Yu, Victor L; Zaoutis, Theoklis
2006 Oct 15;43(8):1031-1039, Clinical infectious diseases
— id: 68683, year: 2006, vol: 43, page: 1031, stat: Journal Article,

The impact of sex and contraceptive therapy on the plasma and intracellular pharmacokinetics of zidovudine
Aweeka, Francesca T; Rosenkranz, Susan L; Segal, Yoninah; Coombs, Robert W; Bardeguez, Arlene; Thevanayagam, Lourdes; Lizak, Patricia; Aberg, Judith; Watts, D Heather
2006 Sep 11;20(14):1833-1841, AIDS
OBJECTIVES:: Zidovudine remains part of combination antiretroviral therapy. Pharmacological studies rely on quantitation of active triphosphates in peripheral blood mononuclear cells. This study evaluated the impact of female sex and contraceptive therapy on zidovudine plasma and intracellular pharmacokinetics and the impact of contraceptive therapy on HIV viral load. METHODS:: Serial plasma and intracellular zidovudine pharmacokinetics following oral and intravenous dosing were determined in 18 men and 20 women treated with zidovudine. Women could repeat pharmacokinetics assessment following 2 months oral or injectable contraceptive therapy. Zidovudine plasma and intracellular mono-, di- and triphosphate concentrations were determined by liquid chromatography tandem mass spectrometry. Plasma and cervical viral loads were determined preceding and following 2 months of contraceptive therapy in women. RESULTS:: Men exhibited higher area under the concentration versus time curve for intracellular zidovudine and zidovudine-monophosphate following oral and intravenous dosing and higher zidovudine triphosphate following oral dosing. There was no difference between men and women in plasma zidovudine parameters. Furthermore, contraceptive therapy had no effect on zidovudine plasma or intracellular pharmacokinetics or on plasma or cervical HIV-1 RNA levels. CONCLUSIONS:: Using an optimized pharmacokinetic design, this study indicated men exhibit significantly higher zidovudine-monophosphate and zidovudine-triphosphate exposure following zidovudine oral administration, having implications for drug toxicity and overall tolerance of zidovudine therapy. The lack of an effect of contraceptive therapy on zidovudine pharmacokinetics is surprising in light of previous pharmacokinetic studies for drugs eliminated primarily through glucuronidation. Contraceptive therapy had no effect on plasma or cervical viral load, results consistent with previous findings
— id: 68686, year: 2006, vol: 20, page: 1833, stat: Journal Article,

Neuropsychiatric complications of antiretroviral therapy
Cespedes, Michelle S; Aberg, Judith A
2006 ;29(10):865-874, Drug safety
Neuropsychiatric adverse effects related to potent antiretroviral therapy are among the complications that can lead to poor adherence, treatment interruptions, or change of antiretroviral therapy regimens. For a historical perspective, we review early literature and case reports with CNS adverse effects attributed to antiretrovirals. The variability of the cerebrospinal fluid penetration of individual antiretrovirals may contribute to their potential for behavioural and psychiatric manifestations.The majority of neuropsychiatric complications related to potent antiretroviral therapy have been associated with the use of the efavirenz. Updates on the risk of neuropsychiatric manifestations with efavirenz use in patients with a history of psychiatric disorders or substance abuse are reviewed. We include a critical review of recently published data on the long-term CNS adverse effects with efavirenz. Special attention is given to the results of recent investigations on the relationship between the pharmacogenomics of genes responsible for efavirenz metabolism and the plasma concentration of efavirenz. It is important to note that there is no established direct correlation of efavirenz concentrations and symptoms. It is not recommended for practitioners to adjust efavirenz doses in order to prevent or alleviate CNS adverse effects. Patients may be placed at risk for virological failure and resistance if they receive suboptimal doses of efavirenz.The aim of this article is to give a concise review and an update on recent literature concerning neuropsychiatric effects of antiretroviral use in HIV-infected patients. Our intent is to present practitioners with data that can be used in a practical way to both educate and improve outcomes in the HIV-infected patient population
— id: 68685, year: 2006, vol: 29, page: 865, stat: Journal Article,

Safety and efficacy of extended-release niacin for the treatment of dyslipidaemia in patients with HIV infection: AIDS Clinical Trials Group Study A5148
Dube, Michael P; Wu, Julia W; Aberg, Judith A; Deeg, Mark A; Alston-Smith, Beverly L; McGovern, Mark E; Lee, Daniel; Shriver, Sharon L; Martinez, Ana I; Greenwald, Martha; Stein, James H
2006 ;11(8):1081-1089, Antiviral therapy
BACKGROUND: Dyslipidaemia is very common in patients with HIV infection, but current therapies are often suboptimal. Since niacin may cause insulin resistance and hepatotoxicity, it has generally been avoided in this setting. METHODS: Non-diabetic male subjects (n=33) who had well-controlled HIV infection on antiretroviral therapy, fasting triglycerides > or =2.26 mmol/l and non-high density lipoprotein cholesterol (non-HDL-C) > or =4.66 mmol/l received escalating doses of extended-release niacin (ERN) up to 2,000 mg nightly for up to 44 weeks. RESULTS: Fourteen subjects (42%) had pre-diabetes at entry. Twenty-three subjects (70%) received the maximum dose, eight (24%) received 1,500 mg. Niacin was well-tolerated. Only four subjects (12%) discontinued study treatment. There were small increases in fasting glycaemia and insulin resistance estimated by the homeostasis model assessment, but insulin resistance measures from the 2-h oral glucose tolerance test only transiently worsened. No subject developed persistent fasting hyperglycaemia; one had persistently elevated 2-h glucose >11.1 mmol/l. There were no significant changes in serum transaminases or uric acid. At week 48, the median change in fasting lipid levels in mmol/l (interquartile range) were: total cholesterol -0.21 (-1.35, -0.05), HDL-C +0.013 (-0.03,+0.28), non-HDL-C -0.49 (-1.37,+0.08) and triglycerides -1.73 (-3.68, -0.72). Favourable changes in large HDL and large very low density lipoprotein particle concentration were observed by nuclear magnetic resonance spectroscopy. CONCLUSIONS: ERN in doses up to 2,000 mg daily was safe, well-tolerated and efficacious in HIV-infected subjects with atherogenic dyslipidaemia. Increases in glycaemia and insulin resistance tended to be transient
— id: 71295, year: 2006, vol: 11, page: 1081, stat: Journal Article,

A Tale of Two Fungi in a Person With HIV
Faulhaber, Jason; Aberg, Judith A; Puthawala, Khalid; Addrizzo-Harris, Doreen
2006 ;8(4):2-2, MedGenMed: Medscape General Medicine
— id: 71296, year: 2006, vol: 8, page: 2, stat: Journal Article,

A randomized trial of the efficacy and safety of fenofibrate versus pravastatin in HIV-infected subjects with lipid abnormalities: AIDS Clinical Trials Group Study 5087
Aberg, Judith A; Zackin, Robert A; Brobst, Susan W; Evans, Scott R; Alston, Beverly L; Henry, W Keith; Glesby, Marshall J; Torriani, Francesca J; Yang, Yijun; Owens, Susan I; Fichtenbaum, Carl J
2005 Sep;21(9):757-767, AIDS research & human retroviruses
There is a paucity of information on the safety and efficacy of lipid-lowering therapy for dyslipidemia associated with human immunodeficiency virus (HIV) and antiretroviral therapy. Our objective was to determine whether fenofibrate and pravastatin were equivalent for the treatment of combined dyslipidemia in HIV as measured by a composite of the National Cholesterol Education Project (NCEP) goals based on absolute values for low-density lipoprotein (LDL), triglycerides (TG), and high-density lipoprotein (HDL) and to compare the safety of these agents through 48 weeks. This was a randomized, open-label trial with subjects assigned to fenofibrate 200 mg (n = 88) or pravastatin 40 mg (n = 86) daily. Subjects who failed to reach the NCEP composite goal on monotherapy by week 12 received both drugs. The composite goal at week 12 was achieved in 1% of fenofibrate and 5% of pravastatin subjects. At week 16, 69/88 subjects on fenofibrate added pravastatin (FP) and 67/86 subjects on pravastatin added fenofibrate (PF). At week 48, 7% FP subjects and 3% PF subjects achieved the composite goal. Median changes in LDL/HDL/TG/non-HDL were -8/+5/-144/+50 and -14/+2/-66/+34 mg/dl in subjects receiving FP and PF, respectively. There were few adverse events and no rhabdomyolysis reported. Combination therapy with fenofibrate and pravastatin for HIV-related dyslipidemia provides substantial improvements in lipid parameters and appears safe, but is unlikely to achieve all NCEP targets for lipid levels
— id: 58777, year: 2005, vol: 21, page: 757, stat: Journal Article,

Cardiovascular and Endothelial Disease in HIV Infection
Cespedes MS; Aberg JA
2005 Jul;7(4):309-315, Current infectious disease reports
As combination antiretroviral therapy improves outcome for HIV-infected patients, more focus is directed on the durability of these regimens and the prevention of long-term adverse events. Given the prevalence of metabolic complications associated with combination therapy, namely insulin resistance, dyslipidemia, and truncal adiposity, interest in whether these complications predispose patients to cardiovascular disease prematurely is appropriate. This paper reviews the most recent data regarding the effects of HIV and its treatment on endothelial dysfunction, serum biomarkers, and vascular indices, and provides an update on the risk for cardiovascular events in the HIV-infected patient population
— id: 55951, year: 2005, vol: 7, page: 309, stat: Journal Article,

Case files from the Bellevue Hospital Center at New York University--lipoatrophy following long-term antiretroviral therapy
Daskalakis, Demetre; Aberg, Judith A
2005 ;7(4):9-9, MedGenMed: Medscape General Medicine
— id: 64585, year: 2005, vol: 7, page: 9, stat: Journal Article,

Effect of efavirenz on the pharmacokinetics of simvastatin, atorvastatin, and pravastatin: results of AIDS Clinical Trials Group 5108 Study
Gerber, John G; Rosenkranz, Susan L; Fichtenbaum, Carl J; Vega, Jose M; Yang, Amy; Alston, Beverly L; Brobst, Susan W; Segal, Yoninah; Aberg, Judith A
2005 Jul 1;39(3):307-312, Journal of acquired immune deficiency syndromes. JAIDS
Efavirenz (EFV) is associated with hyperlipidemia when used in combination with other antiretroviral drugs. EFV is a mixed inducer/inhibitor of cytochrome P450 (CYP) 3A4 isozyme and may interact with hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitors that are primarily metabolized via CYP3A4. To assess the drug-drug interaction of EFV used in combination with simvastatin (SIM), atorvastatin (ATR), or pravastatin (PRA), an open-label trial was conducted in 52 healthy adult HIV-seronegative subjects across AIDS Clinical Trials Group sites in the United States. Subjects received 40 mg of SIM, 10 mg of ATR, or 40 mg of PRA daily on days 0 through 3 and days 15 through 18. EFV was administered daily at a dose of 600 mg on days 4 through 18. SIM, ATR, and PRA concentrations were determined before and after EFV, and EFV concentrations were determined before and after statins. EFV reduced SIM acid exposure (area under the curve at 0 to 24 hours [AUC0-24 h]) by 58% (Wilcoxon signed rank test, P=0.003) and active HMG-CoA reductase inhibitory activity by 60% (P<0.001). EFV reduced ATR exposure by 43% (P<0.001) and the total active ATR exposure by 34% (P=0.005). EFV administration resulted in a 40% decrease in PRA exposure (P=0.005). SIM, ATR, and PRA had no effect on non-steady-state EFV concentrations. In conclusion, EFV, when administered with SIM, ATR, or PRA, can result in significant induction of statin metabolism. The reduced inhibition of HMG-CoA reductase activity during coadministration of EFV may result in diminished antilipid efficacy at usual doses of SIM, ATR, and PRA
— id: 58780, year: 2005, vol: 39, page: 307, stat: Journal Article,

Pharmacokinetic interactions between indinavir plus ritonavir and calcium channel blockers
Glesby, Marshall J; Aberg, Judith A; Kendall, Michelle A; Fichtenbaum, Carl J; Hafner, Richard; Hall, Stephen; Grosskopf, Nicole; Zolopa, Andrew R; Gerber, John G
2005 Aug;78(2):143-153, Clinical pharmacology & therapeutics
BACKGROUND: Hypertension is an important modifiable cardiac risk factor in human immunodeficiency virus (HIV)-infected patients. Calcium channel blockers are substrates of cytochrome P450 3A and are commonly prescribed for hypertension. We evaluated potential bidirectional pharmacokinetic interactions between calcium channel blockers and coadministered indinavir and ritonavir. METHODS: Healthy HIV- seronegative subjects received 120 mg diltiazem daily or 5 mg amlodipine daily for days 1 to 7 and 20 to 26. All subjects received 100 mg ritonavir and 800 mg indinavir every 12 hours on days 8 to 26. Twenty-four-hour pharmacokinetic collection was performed on days 7 and 26, with 12-hour collection on day 19. RESULTS: Indinavir plus ritonavir increased the median amlodipine area under the curve from 0 to 24 hours (AUC) by 89.8%, from 122 to 230 ng.h/mL (n = 18, P < .0001), and increased the median diltiazem AUC by 26.5%, from 800 to 1060 ng.h/mL (n = 13, P = .06). Of 13 subjects, 2 (15%) had greater than 4-fold increases in diltiazem AUC. Desacetyldiltiazem AUC increased by 102.2% (P = .001), and desmethyldiltiazem AUC decreased by 27.4% (P = .01). Neither amlodipine nor diltiazem affected steady-state AUCs of the protease inhibitors. No serious cardiovascular adverse effects were observed. CONCLUSIONS: Indinavir plus ritonavir increases the AUCs of both amlodipine and diltiazem, which may result in an increased response. If coadministration is indicated, amlodipine or diltiazem should be initiated at low doses with careful titration to response and side effects
— id: 58779, year: 2005, vol: 78, page: 143, stat: Journal Article,

Phase I evaluation of the safety and pharmacokinetics of murine-derived anticryptococcal antibody 18B7 in subjects with treated cryptococcal meningitis
Larsen, Robert A; Pappas, Peter G; Perfect, John; Aberg, Judith A; Casadevall, Arturo; Cloud, Gretchen A; James, Robert; Filler, Scott; Dismukes, William E
2005 Mar;49(3):952-958, Antimicrobial agents & chemotherapy
A promising approach to improving outcomes in patients with cryptococcal meningitis is to use adjunctive passive immunotherapy with a monoclonal antibody (MAb) directed against the capsular polysaccharide of Cryptococcus neoformans. This is the first application of MAb therapy for the treatment of a fungal disease in humans. We determined the safety and maximum tolerated dose of the murine anticryptococcal MAb 18B7 in a phase I dose-escalation study. The subjects were human immunodeficiency virus-infected patients who had been successfully treated for cryptococcal meningitis. Six dosing cohorts received MAb 18B7 at 0.01 to 2 mg/kg of body weight as a single infusion. Three patients each received 0.01, 0.05, 0.2, and 0.5 mg of MAb 18B7 per kg without significant adverse events. Four of the subjects who received the 1-mg/kg dose had mild study drug-associated toxicity, including transient nausea, vomiting, back pain, and urticarial rash. Two of the subjects who received 2 mg/kg developed drug-associated mild to moderate nausea, vomiting, chills, and myalgias. One of the subjects who received 2 mg/kg developed intracranial hypertension 10 weeks after MAb 18B7 administration. Serum cryptococcal antigen titers in the cohorts receiving doses of 1 and 2 mg/kg declined by a median of twofold at 1 week and a median of threefold at 2 weeks postinfusion, but the titers subsequently returned toward the baseline values by week 12. The half-life of MAb 18B7 in serum was approximately 53 h, while the MAb was undetectable in the cerebrospinal fluid of all patients. These data support the continued investigation of MAb 18B7 at a maximum single dose of 1.0 mg/kg
— id: 58781, year: 2005, vol: 49, page: 952, stat: Journal Article,

Undetectable plasma HIV RNA load predicts success after hepatitis B vaccination in HIV-infected persons
Overton, Edgar Turner; Sungkanuparph, Somnuek; Powderly, William G; Seyfried, Warren; Groger, Richard K; Aberg, Judith A
2005 Oct 1;41(7):1045-1048, Clinical infectious diseases
Human immunodeficiency virus (HIV)-infected patients respond poorly to hepatitis B vaccination. Records of 194 HIV-infected patients were reviewed for factors associated with successful hepatitis B vaccination. Thirty-four patients (17.5%) developed a protective antibody response. In a logistic regression model, only a plasma HIV RNA level of <400 copies/mL at the time of vaccination was associated with a protective antibody response (P=.003)
— id: 58778, year: 2005, vol: 41, page: 1045, stat: Journal Article,

Dyslipidemia in HIV patients
Tungsiripat, Marisa; Aberg, Judith A
2005 Dec;72(12):1113-1120, Cleveland Clinic journal of medicine
Thanks to antiretroviral therapy, people with human immunodeficiency virus (HIV) infection are living longer, but as they do, non-HIV medical problems become more relevant. In particular, dyslipidemia, an important reversible risk factor for cardiovascular disease, has been linked to HIV infection and its treatment. Although controversy remains as to whether people with HIV infections will develop premature coronary heart disease, it seems prudent to manage dyslipidemia in these patients just as we do in our HIV-negative patients. Interactions between lipid-lowering drugs and antiretroviral drugs require special attention
— id: 68688, year: 2005, vol: 72, page: 1113, stat: Journal Article,

Drug information handbook for dentistry
Wynn, Richard L; Meiller, Timothy F; Crossley, Harold L; Aberg, Judith A
Hudson OH : Lexi-Comp, 2005,
— id: 2158, year: 2005, vol: , page: , stat: ,

Primary care guidelines for the management of persons infected with human immunodeficiency virus: recommendations of the HIV Medicine Association of the Infectious Diseases Society of America
Aberg, Judith A; Gallant, Joel E; Anderson, Jean; Oleske, James M; Libman, Howard; Currier, Judith S; Stone, Valerie E; Kaplan, Jonathan E
2004 Sep 1;39(5):609-629, Clinical infectious diseases
— id: 47054, year: 2004, vol: 39, page: 609, stat: Journal Article,

Safety of discontinuation of maintenance therapy for disseminated histoplasmosis after immunologic response to antiretroviral therapy
Goldman, Mitchell; Zackin, Robert; Fichtenbaum, Carl J; Skiest, Daniel J; Koletar, Susan L; Hafner, Richard; Wheat, L Joseph; Nyangweso, Peter M; Yiannoutsos, Constantin T; Schnizlein-Bick, Carol T; Owens, Susan; Aberg, Judith A
2004 May 15;38(10):1485-1489, Clinical infectious diseases
We performed a prospective observational study to assess the safety of stopping maintenance therapy for disseminated histoplasmosis among human immunodeficiency virus infected patients after response to antiretroviral therapy. All subjects received at least 12 months of antifungal therapy and 6 months of antiretroviral therapy before entry. Negative results of fungal blood cultures, urine and serum Histoplasma antigen level of <4.1 units, and CD4+ T cell count of >150 cells/mm3 were required for eligibility. Thirty-two subjects were enrolled; the median CD4+ T cell count at study entry was 289 cells/mm3. No relapses of histoplasmosis occurred after a median duration of follow-up of 24 months. This corresponded to an observed relapse rate of 0 cases per 65 person-years. The median CD4+ T cell count at final study visit was 338 cells/mm3. Discontinuation of antifungal maintenance therapy appears to be safe for patients with acquired immunodeficiency syndrome with previously treated disseminated histoplasmosis and sustained immunologic improvement in response to antiretroviral therapy
— id: 47055, year: 2004, vol: 38, page: 1485, stat: Journal Article,

Discontinuation of maintenance therapy for cryptococcal meningitis in patients with AIDS treated with highly active antiretroviral therapy: an international observational study
Mussini, Cristina; Pezzotti, Patrizio; Miro, Jose M; Martinez, Esteban; de Quiros, Juan Carlos Lopez Bernaldo; Cinque, Paola; Borghi, Vanni; Bedini, Andrea; Domingo, Pere; Cahn, Pedro; Bossi, Philippe; de Luca, Andrea; d'Arminio Monforte, Antonella; Nelson, Mark; Nwokolo, Nneka; Helou, Silvia; Negroni, Ricardo; Jacchetti, Gaia; Antinori, Spinello; Lazzarin, Adriano; Cossarizza, Andrea; Esposito, Roberto; Antinori, Andrea; Aberg, Judith A
2004 Feb 15;38(4):565-571, Clinical infectious diseases
We conducted a retrospective, multicenter study evaluating the safety of discontinuing maintenance therapy for cryptococcal meningitis after immune reconstitution. Inclusion criteria were a previous definitive diagnosis of cryptococcal meningitis, a CD4 cell count of >100 cells/microL while receiving highly active antiretroviral therapy (HAART), and the subsequent discontinuation of maintenance therapy for cryptococcal meningitis. The primary end point was relapse of cryptococcal disease. As of July 2002, 100 patients were enrolled. When maintenance therapy was discontinued, the median CD4 cell count was 259 cells/microL and the median plasma virus load was <2.30 log10 copies/mL, and serum cryptococcal antigen was undetectable in 56 patients. During a median follow-up period of 28.4 months (range, 6.7-64.5; 262 person-years), 4 events were observed (incidence, 1.53 events per 100 person-years; 95% confidence interval, 0.42-3.92). Three of these patients had a CD4 cell count of >100 cells/microL and a positive serum cryptococcal antigen test result during the recurrent episode. In conclusion, discontinuation of maintenance therapy for cryptococcal meningitis is safe if the CD4 cell count increases to >100 cells/microL while receiving HAART. Recurrent cryptococcal infection should be suspected in patients whose serum cryptococcal antigen test results revert back to positive after discontinuation of maintenance therapy
— id: 47057, year: 2004, vol: 38, page: 565, stat: Journal Article,

Recombinant interferon- gamma 1b as adjunctive therapy for AIDS-related acute cryptococcal meningitis
Pappas, Peter G; Bustamante, Beatriz; Ticona, Eduardo; Hamill, Richard J; Johnson, Philip C; Reboli, Annette; Aberg, Judith; Hasbun, Rodrigo; Hsu, Henry H
2004 Jun 15;189(12):2185-2191, Journal of infectious diseases
We conducted a phase 2, double-blind, placebo-controlled study to evaluate the safety and antifungal activity of adjuvant recombinant interferon (rIFN)- gamma 1b in patients with acquired immunodeficiency syndrome and acute cryptococcal meningitis. Patients received 100 or 200 microg of rIFN- gamma 1b or placebo, thrice weekly for 10 weeks, plus standard therapy with intravenous amphotericin B, with or without flucytosine, followed by therapy with fluconazole. End points included conversion of cerebrospinal fluid fungal cultures from positive to negative at 2 weeks, resolution of symptoms, and survival. Among 75 patients, 2-week culture conversion occurred in 13% of placebo recipients, 36% of rIFN- gamma 1b (100 microg) recipients, and 32% of rIFN- gamma 1b (200 microg) recipients. There was a trend toward improved combined mycologic and clinical success in rIFN- gamma 1b recipients (26% vs. 8%; P=.078). Therapy with rIFN- gamma 1b was well tolerated, and there was no apparent influence on serial CD4 cell counts and human immunodeficiency virus load measurements. Adjunctive therapy with rIFN- gamma 1b holds promise for patients with acute cryptococcal meningitis and warrants further study
— id: 58782, year: 2004, vol: 189, page: 2185, stat: Journal Article,

Cure of acute hepatitis C in HIV co-infection?
Ristig, Maria B; Tebas, Pablo; Gandy, Iver; Qaqish, Roula; Aberg, Judith A
2004 Mar;38(3):303-303, Journal of clinical gastroenterology
— id: 47056, year: 2004, vol: 38, page: 303, stat: Journal Article,

Cardiovascular risk among HIV-positive patients on antiretroviral therapy
Aberg, Judith A
2003 Sep;2 Suppl 2(6):S24-S39, Journal of the International Association of Physicians in AIDS Care : JIAPAC
Dyslipidemia is now recognized as a significant potential adverse event in HIV-positive patients who are on ART. The tide of evidence continues to flow between the shore of HIV being the primary factor behind increased cardiovascular risk in HIV-positive patients, and the ocean of HAART being the primary cause. However, there clearly is an association between long-term infection with HIV and metabolic abnormalities. HIV-infected adults should undergo evaluation and treatment based on the NCEP ATP III guidelines. The NCEP recommends non-pharmacologic interventions be given a thorough trial prior to consideration of drug therapy. The recommendations also stipulate that intensive therapy with lipid-lowering medications should be used in individuals with metabolic syndrome. This includes aggressive treatment of hypertension, diabetes, and dyslipidemia. The NCEP also emphasizes the importance of smoking cessation, weight reduction, increased physical activity, and a salubrious diet. The fundamental message still is that physicians must treat HIV infection first. The choice of ART depends on many patient-specific factors, of which cardiovascular risk is only one
— id: 47059, year: 2003, vol: 2 Suppl 2, page: S24, stat: Journal Article,

Pulmonary cryptococcosis in normal hosts: treat or observe?
Aberg, Judith A
2003 Dec;124(6):2049-2051, Chest
— id: 47058, year: 2003, vol: 124, page: 2049, stat: Journal Article,

A study of discontinuing maintenance therapy in human immunodeficiency virus-infected subjects with disseminated Mycobacterium avium complex: AIDS Clinical Trial Group 393 Study Team
Aberg, Judith A; Williams, Paige L; Liu, Tun; Lederman, Howard M; Hafner, Richard; Torriani, Francesca J; Lennox, Jeffrey L; Dube, Michael P; MacGregor, Rob Roy; Currier, Judith S
2003 Apr 1;187(7):1046-1052, Journal of infectious diseases
The present nonrandomized prospective study evaluated whether antimycobacterial therapy for disseminated Mycobacterium avium complex (MAC) could be withdrawn from human immunodeficiency virus-infected subjects who experienced immunologic recovery while receiving highly active antiretroviral therapy (HAART). Eligible subjects had received macrolide-based therapy for least 12 months, were asymptomatic for MAC, had received HAART for at least 16 weeks, and had CD4+ T cell counts >100 cells/microL. Forty-eight subjects were enrolled, with a median CD4+ T cell count of 240 cells/microL at the time of discontinuation of MAC therapy. Forty-seven subjects remained MAC free, whereas 1 subject developed localized MAC osteomyelitis. The median duration of follow-up while not receiving therapy was 77 weeks, and the incidence of MAC infection was 1.44/100 person-years (95% confidence interval, 0.04-8.01). Withdrawal of anti-MAC therapy appears to be safe in patients who have been treated with a macrolide-based regimen for at least 1 year and have an immunologic response on HAART
— id: 47064, year: 2003, vol: 187, page: 1046, stat: Journal Article,

Short-term effects of cannabinoids in patients with HIV-1 infection: a randomized, placebo-controlled clinical trial
Abrams, Donald I; Hilton, Joan F; Leiser, Roslyn J; Shade, Starley B; Elbeik, Tarek A; Aweeka, Francesca T; Benowitz, Neal L; Bredt, Barry M; Kosel, Bradley; Aberg, Judith A; Deeks, Steven G; Mitchell, Thomas F; Mulligan, Kathleen; Bacchetti, Peter; McCune, Joseph M; Schambelan, Morris
2003 Aug 19;139(4):258-266, Annals of internal medicine
BACKGROUND: Cannabinoid use could potentially alter HIV RNA levels by two mechanisms: immune modulation or cannabinoid-protease inhibitor interactions (because both share cytochrome P-450 metabolic pathways). OBJECTIVE: To determine the short-term effects of smoked marijuana on the viral load in HIV-infected patients. DESIGN: Randomized, placebo-controlled, 21-day intervention trial. SETTING: The inpatient General Clinical Research Center at the San Francisco General Hospital, San Francisco, California. PARTICIPANTS: 67 patients with HIV-1 infection. INTERVENTION: Participants were randomly assigned to a 3.95%-tetrahydrocannabinol marijuana cigarette, a 2.5-mg dronabinol (delta-9-tetrahydrocannabinol) capsule, or a placebo capsule three times daily before meals. MEASUREMENTS: HIV RNA levels, CD4+ and CD8+ cell subsets, and pharmacokinetic analyses of the protease inhibitors. RESULTS: 62 study participants were eligible for the primary end point (marijuana group, 20 patients; dronabinol group, 22 patients; and placebo group, 20 patients). Baseline HIV RNA level was less than 50 copies/mL for 36 participants (58%), and the median CD4+ cell count was 340 x 109 cells/L. When adjusted for baseline variables, the estimated average effect versus placebo on change in log10 viral load from baseline to day 21 was -0.07 (95% CI, -0.30 to 0.13) for marijuana and -0.04 (CI, -0.20 to 0.14) for dronabinol. The adjusted average changes in viral load in marijuana and dronabinol relative to placebo were -15% (CI, -50% to 34%) and -8% (CI, -37% to 37%), respectively. Neither CD4+ nor CD8+ cell counts appeared to be adversely affected by the cannabinoids. CONCLUSIONS: Smoked and oral cannabinoids did not seem to be unsafe in people with HIV infection with respect to HIV RNA levels, CD4+ and CD8+ cell counts, or protease inhibitor levels over a 21-day treatment
— id: 47060, year: 2003, vol: 139, page: 258, stat: Journal Article,

Guidelines for the evaluation and management of dyslipidemia in human immunodeficiency virus (HIV)-infected adults receiving antiretroviral therapy: recommendations of the HIV Medical Association of the Infectious Disease Society of America and the Adult AIDS Clinical Trials Group
Dube, Michael P; Stein, James H; Aberg, Judith A; Fichtenbaum, Carl J; Gerber, John G; Tashima, Karen T; Henry, W Keith; Currier, Judith S; Sprecher, Dennis; Glesby, Marshall J
2003 Sep 1;37(5):613-627, Clinical infectious diseases
— id: 47061, year: 2003, vol: 37, page: 613, stat: Journal Article,

Infectious diseases handbook : including antimicrobial therapy & diagnostic tests/procedures
Isada, Carlos M; Kasten, Bernard L; Goldman, Morton P; Gray, Larry D; Aberg, Judith A
Hudson OH : Lexi-Comp, 2003,
— id: 2159, year: 2003, vol: , page: , stat: ,

Tolerance of efavirenz-induced central nervous system side effects in HIV-infected individuals with a history of substance abuse
Juethner, Salome N; Seyfried, Warren; Aberg, Judith A
2003 May-Jun;4(3):145-149, HIV clinical trials
PURPOSE: There is no published data looking at tolerance of efavirenz (EFV) in patients who abuse cocaine or alcohol (EtOH). The objective of this study was to determine whether individuals with a current or past history of cocaine or EtOH abuse are more likely to experience EFV-induced central nervous system (CNS) side effects that warrant discontinuation of EFV compared with those who do not abuse substances. METHOD: Retrospective chart review of all patients who received a nonnucleoside reverse transcriptase inhibitor (NNRTI) at an inner city Ryan White Title III-supported health clinic during 1992-2001. RESULTS: During the study period, 99/279 (78% African American, 88% male) patients were prescribed an NNRTI. Patients on an NNRTI with either a history of or current substance abuse (SA) abused cocaine (30%), EtOH (70%), or marijuana (33%). Of these, 38% abused more than one substance. There were 39/63 EFV patients who were substance abusers compared with 16/36 patients not on EFV who were substance abusers (p =.09). Examining patients on EFV, 6/24 with SA and 7/39 without SA reported a CNS side effect (p =.54). Among patients on EFV, 4/24 with SA versus 13/39 without SA reported stopping EFV (p =.24). CONCLUSION: SA did not have a significant effect on patients' ability to remain on EFV. Patients who abused cocaine or EtOH or smoked marijuana were at no more risk of exhibiting CNS side effects than those who denied a history of substance abuse
— id: 47062, year: 2003, vol: 4, page: 145, stat: Journal Article,

Nonnucleoside reverse transcriptase inhibitor resistance among antiretroviral-naive HIV-positive pregnant women
Juethner, Salome N; Williamson, Catherine; Ristig, Maria B; Tebas, Pablo; Seyfried, Warren; Aberg, Judith A
2003 Feb 1;32(2):153-156, Journal of acquired immune deficiency syndromes. JAIDS
From 1999 to 2001, the overall prevalence of resistance in the antiretroviral (ART)-naive population in St. Louis, Missouri, was 17%. We sought to determine if resistance testing in ART-naive HIV-positive pregnant women identified resistant mutations, which would modify our initial choice of therapy. A retrospective chart review was performed on all HIV-positive pregnant women seen from January 2000 to December 2001 at a university hospital. There were 72 pregnancies. Twenty-seven of 72 patients were ART naive. Genotype testing was performed in 18 of 27 naive patients. Three of 18 ART-naive patients (17%) had primary resistance (95% CI: 4%-41%) by genotype to NNRTIs. The primary mutation, G190S, conferring resistance to NNRTIs was present in 1 patient. Another had the K103N mutation. One had the K103R mutation, which conferred phenotypic resistance to NNRTIs by 8.3-fold, warranting a change in the initial regimen. In our community, resistance testing in ART-naive pregnant patients is warranted. Switching later to a more complex regimen during pregnancy may adversely affect adherence, resulting in virologic failure. Strategies to avoid prescribing a suboptimal regimen include waiting to initiate ART until the resistance testing results are available and/or beginning ART with a protease inhibitor-based regimen if the patient is already in the third trimester of pregnancy at the time of her initial clinic presentation
— id: 47065, year: 2003, vol: 32, page: 153, stat: Journal Article,

Effect of simultaneous versus staggered dosing on pharmacokinetic interactions of protease inhibitors
Washington, Carla B; Flexner, Charles; Sheiner, Lewis B; Rosenkranz, Susan L; Segal, Yoninah; Aberg, Judith A; Blaschke, Terrence F
2003 May;73(5):406-416, Clinical pharmacology & therapeutics
OBJECTIVE: The aim of this study was to determine whether pharmacokinetic interactions between the protease inhibitors saquinavir soft gel, nelfinavir, and ritonavir are affected by the timing of administration. STUDY DESIGN: We used an open-label, 6-period, incomplete Latin square crossover study in 18 human immunodeficiency virus-negative subjects. Each received single oral doses of 2 of the 3 protease inhibitors during each of 6 periods. Single doses were given either simultaneously or separated by 4 hours. The order of the periods was balanced, and periods were separated by 2 days. We measured protease inhibitor concentrations over a 24-hour period by HPLC and estimated pharmacokinetic parameters by noncompartmental methods. RESULTS: Median saquinavir area under the curve (AUC) increased by 62-fold when ritonavir was coadministered, by 50-fold when ritonavir was given 4 hours earlier, and by 16-fold when saquinavir preceded ritonavir by 4 hours. Saquinavir AUC increased by 7-fold when nelfinavir was coadministered. Nelfinavir AUC increased by 2.5-fold with coadministration of ritonavir and by 1.8- and 2.1-fold when ritonavir was administered before nelfinavir and after nelfinavir, respectively. Ritonavir AUCs were unaffected by coadministration of the other drugs. The effect of ritonavir on the kinetics of saquinavir persisted for at least 48 hours after a single dose of ritonavir, suggesting the possibility of metabolic intermediates that form inhibitory complexes. CONCLUSION: Except for saquinavir followed by ritonavir, there is little difference in protease inhibitor exposure for simultaneous or staggered doses. The persistent effect of ritonavir suggests the possibility that lower doses and longer dosing intervals might be effective when ritonavir is used to boost concentrations of other protease inhibitors
— id: 47063, year: 2003, vol: 73, page: 406, stat: Journal Article,

A case of nocardia osteomyelits--is HIV to blame?
Aberg, Judith A
2002 Feb;12(2):77-77, AIDS reader
— id: 47070, year: 2002, vol: 12, page: 77, stat: Journal Article,

Localized osteomyelitis due to Mycobacterium avium complex in patients with Human Immunodeficiency Virus receiving highly active antiretroviral therapy
Aberg, Judith A; Chin-Hong, Peter V; McCutchan, Allen; Koletar, Susan L; Currier, Judith S
2002 Jul 1;35(1):E8-E13, Clinical infectious diseases
We describe 3 patients who developed atypical manifestations of Mycobacterium avium complex (MAC) infection >10 months (range, 3-16 months) after attaining sustained CD4(+) T cell counts of >100 cells/microL while receiving antiretroviral therapy and not receiving MAC prophylaxis. The common features of these cases include the degree of immune reconstitution, the unusual locations of the infections, and the absence of a systemic inflammatory response. The low rate of these unusual MAC infections does not warrant continuation of primary or secondary prophylaxis after presumed immune reconstitution
— id: 47068, year: 2002, vol: 35, page: E8, stat: Journal Article,

A pilot study of the discontinuation of antifungal therapy for disseminated cryptococcal disease in patients with acquired immunodeficiency syndrome, following immunologic response to antiretroviral therapy
Aberg, Judith A; Price, Richard W; Heeren, Dorie M; Bredt, Barry
2002 Apr 15;185(8):1179-1182, Journal of infectious diseases
To determine whether microbiologic cure of acquired immunodeficiency syndrome (AIDS)-related disseminated cryptococcosis is possible in patients receiving highly active antiretroviral therapy (HAART), antifungal therapy was discontinued in 6 patients with a history of disseminated cryptococcosis who had received > or =12 months of antifungal therapy. All were asymptomatic and had absolute CD4+ T cell counts of >150 cells/microL (range, 178-525 cells/microL). Blood, cerebrospinal fluid (CSF), and urine samples were obtained for fungal culture. Serum and CSF cryptococcal antigen titers were also obtained. All 6 patients had CSF and blood cultures negative for Cryptococcus neoformans and were receiving HAART. All patients' subsequent cultures remained sterile, and all patients were clinically asymptomatic 24 months after ending antifungal therapy. Disseminated cryptococcal disease can be cured by prolonged antifungal therapy in some patients with AIDS who experience sustained CD4 lymphocyte increases while receiving HAART
— id: 47069, year: 2002, vol: 185, page: 1179, stat: Journal Article,

Pharmacokinetic interactions between protease inhibitors and statins in HIV seronegative volunteers: ACTG Study A5047
Fichtenbaum, Carl J; Gerber, John G; Rosenkranz, Susan L; Segal, Yoninah; Aberg, Judith A; Blaschke, Terrence; Alston, Beverly; Fang, Fang; Kosel, Bradley; Aweeka, Francesca
2002 Mar 8;16(4):569-577, AIDS
OBJECTIVE: Lipid lowering therapy is used increasingly in persons with HIV infection in the absence of safety data or information on drug interactions with antiretroviral agents. The primary objectives of this study were to examine the effects of ritonavir (RTV) plus saquinavir soft-gel (SQVsgc) capsules on the pharmacokinetics of pravastatin, simvastatin, and atorvastatin, and the effect of pravastatin on the pharmacokinetics of nelfinavir (NFV) in order to determine clinically important drug-drug interactions. DESIGN: Randomized, open-label study in healthy, HIV seronegative adults at AIDS Clinical Trials Units across the USA. METHODS: Three groups of subjects (arms 1, 2, and 3) received pravastatin, simvastatin or atorvastatin (40 mg daily each) from days 1-4 and 15-18. In these groups, RTV 400 mg and SQVsgc 400 mg twice daily were given from days 4-18. A fourth group (arm 4) received NFV 1250 mg twice daily from days 1-14 with pravastatin 40 mg daily added from days 15-18. Statin and NFV levels were measured by liquid chromatography/tandem mass spectrometry. RESULTS: Fifty-six subjects completed both pharmacokinetic study days. In arms 1-3, the median estimated area under the curves (AUC)(0-24) for the statins were: pravastatin (arm 1, n = 13), 151 and 75 ng.h/ml on days 4 and 18 (decline of 50% in presence of RTV/SQVsgc), respectively (P = 0.005); simvastatin (arm 2, n = 14), 17 and 548 ng.h/ml on days 4 and 18 (increase of 3059% in the presence of RTV/SQVsgc), respectively (P < 0.001); and total active atorvastatin (arm 3, n = 14), 167 and 289 ng.h/ml on days 4 and 18 (increase of 79% in the presence of RTV/SQVsgc), respectively (P < 0.001). In arm 4, the median estimated AUC(0-8) for NFV (24 319 versus 26 760 ng.h/ml; P = 0.58) and its active M8 metabolite (15 565 versus 14 571 ng.h/m; P = 0.63) were not statistically different from day 14 to day 18 (without or with pravastatin). CONCLUSIONS: Simvastatin should be avoided and atorvastatin may be used with caution in persons taking RTV and SQVsgc. Dose adjustment of pravastatin may be necessary with concomitant use of RTV and SQVsgc. Pravastatin does not alter the NFV pharmacokinetics, and thus appears to be safe for concomitant use
— id: 47071, year: 2002, vol: 16, page: 569, stat: Journal Article,

Dual vs single protease inhibitor therapy following antiretroviral treatment failure: a randomized trial
Hammer, Scott M; Vaida, Florin; Bennett, Kara K; Holohan, Mary K; Sheiner, Lewis; Eron, Joseph J; Wheat, Lawrence Joseph; Mitsuyasu, Ronald T; Gulick, Roy M; Valentine, Fred T; Aberg, Judith A; Rogers, Michael D; Karol, Cheryl N; Saah, Alfred J; Lewis, Ronald H; Bessen, Laura J; Brosgart, Carol; DeGruttola, Victor; Mellors, John W
2002 Jul 10;288(2):169-180, JAMA
CONTEXT: Management of antiretroviral treatment failure in patients receiving protease inhibitor (PI)-containing regimens is a therapeutic challenge. OBJECTIVE: To assess whether adding a second PI improves antiviral efficacy of a 4-drug combination in patients with virologic failure while taking a PI-containing regimen. DESIGN: Multicenter, randomized, 4-arm trial, double-blind and placebo-controlled for second PI, conducted between October 1998 and April 2000, for which there was a 24-week primary analysis with extension to 48 weeks. SETTING: Thirty-one participating AIDS (acquired immunodeficiency syndrome) Clinical Trials Units in the United States. PARTICIPANTS: A total of 481 human immunodeficiency virus (HIV)-infected persons with prior exposure to a maximum of 3 PIs and viral load above 1000 copies/mL. INTERVENTION: Selectively randomized assignment (per prior PI exposure) to saquinavir (n = 116); indinavir (n = 69); nelfinavir (n = 139); or placebo twice per day (n = 157); in combination with amprenavir, abacavir, efavirenz, and adefovir dipivoxil. MAIN OUTCOME MEASURES: Primary efficacy analysis involved the proportion with viral load below 200 copies/mL at 24 weeks. Other measures were changes in viral load and CD4 cell count from baseline, adverse events, and HIV drug susceptibility. RESULTS: Of 481 patients, 148 (31%) had a viral load below 200 copies/mL at week 24. The proportions of patients with a viral load below 200 copies/mL in the saquinavir, indinavir, nelfinavir, and placebo arms were 34% (40/116), 36% (25/69), 34% (47/139), and 23% (36/157), respectively. The proportion in the combined dual-PI arms was higher than in the amprenavir-plus-placebo arm (35% [112/324] vs 23% [36/157], respectively; P =.002). Overall, a higher proportion of nonnucleoside reverse transcriptase inhibitor (NNRTI)-naive patients had a viral load below 200 copies/mL compared with NNRTI-experienced patients (43% [115/270] vs 16% [33/211], respectively; P<.001). Baseline HIV-1 hypersusceptibility to efavirenz (< or = 0.4-fold difference in susceptibility compared with reference virus) was associated with suppression of viral load at 24 weeks to below 200 copies/mL (odds ratio [OR], 3.49; 95% confidence interval [CI], 1.62-7.33; P =.001), and more than 10-fold reduction in efavirenz susceptibility, with less likelihood of suppression at 24 weeks (OR, 0.28; 95% CI, 0.09-0.87; P =.03). CONCLUSIONS: In this study of antiretroviral-experienced patients with advanced immunodeficiency, viral load suppression to below 200 copies/mL was achieved in 31% of patients with regimens containing 4 or 5 new drugs. Use of 2 PIs, being naive to NNRTIs, and baseline hypersusceptibility to efavirenz were associated with a favorable outcome
— id: 32249, year: 2002, vol: 288, page: 169, stat: Journal Article,

Phase I dose escalation trial evaluating the pharmacokinetics, anti-human cytomegalovirus (HCMV) activity, and safety of 1263W94 in human immunodeficiency virus-infected men with asymptomatic HCMV shedding
Lalezari, Jacob P; Aberg, Judith A; Wang, Laurene H; Wire, Mary Beth; Miner, Richard; Snowden, Wendy; Talarico, Christine L; Shaw, Shuching; Jacobson, Mark A; Drew, W Lawrence
2002 Sep;46(9):2969-2976, Antimicrobial agents & chemotherapy
1263W94 [maribavir; 5,6-dichloro-2-(isopropylamino)-1,beta-L-ribofuranosyl-1-H-benzimidazole] is a novel benzimidazole compound for treatment of human cytomegalovirus (HCMV) infection and disease, with potent in vitro activity against HCMV and good oral bioavailability. A phase I study was conducted to determine the pharmacokinetics (PK), anti-HCMV activity, and safety of 1263W94 administered as multiple oral doses to human immunodeficiency virus type 1-infected adult male subjects with asymptomatic HCMV shedding. Subjects received one of six dosage regimens (100, 200, or 400 mg three times a day, or 600, 900, or 1,200 mg twice a day) or a placebo for 28 days. 1263W94 demonstrated linear PK, with steady-state plasma 1263W94 profiles predictable based on single-dose data. 1263W94 was rapidly absorbed following oral dosing, and values for the maximum concentration of the drug in plasma and the area under the concentration-time curve increased in proportion to the dose. 1263W94 demonstrated in vivo anti-HCMV activity in semen at all of the dosage regimens tested, with mean reductions in semen HCMV titers of 2.9 to 3.7 log(10) PFU/ml among the four regimens evaluated for anti-HCMV activity. 1263W94 was generally well tolerated; taste disturbance was the most frequently reported adverse event over the 28-day dosing period
— id: 47067, year: 2002, vol: 46, page: 2969, stat: Journal Article,

Tenofovir disoproxil fumarate therapy for chronic hepatitis B in human immunodeficiency virus/hepatitis B virus-coinfected individuals for whom interferon-alpha and lamivudine therapy have failed
Ristig, Maria B; Crippin, Jeffrey; Aberg, Judith A; Powderly, William G; Lisker-Melman, Mauricio; Kessels, Lisa; Tebas, Pablo
2002 Dec 15;186(12):1844-1847, Journal of infectious diseases
A significant proportion of human immunodeficiency virus (HIV) infected patients are coinfected with hepatitis B virus (HBV). Currently available treatments for chronic hepatitis B (interferon [IFN]-alpha and lamivudine [3TC]) have limited long-term utility because of side effects or of the development of resistance. Tenofovir disoproxil fumarate (TDF) is a nucleotide analog with excellent activity in vitro against HBV, which is also active against 3TC-resistant HBV variants. In this 24-week pilot study, the anti-HBV activity of TDF was prospectively evaluated in a cohort of 6 HIV coinfected subjects for whom 3TC and IFN therapy had previously failed. At baseline, all patients were taking 3TC or FTC and were hepatitis B surface antigen and hepatitis B e antigen positive; 4 had cirrhosis. Baseline HBV load was 7.95 log(10) copies/mL. By weeks 12 and 24, HBV load had decreased by 3.1 log(10) copies/mL and 4.3 log(10) copies/mL, respectively. There was a transient increase of transaminases after the initiation of treatment. No patient developed HBe antibodies. TDF is a very promising drug for the treatment of chronic hepatitis B in HIV-infected individuals
— id: 47066, year: 2002, vol: 186, page: 1844, stat: Journal Article,

Presence of macrolide resistance in respiratory flora of HIV-Infected patients receiving either clarithromycin or azithromycin for Mycobacterium avium complex prophylaxis
Aberg JA; Wong MK; Flamm R; Notario GF; Jacobson MA
2001 Nov-Dec;2(6):453-459, HIV clinical trials
Clarithromycin 500 mg po bid or azithromycin 1200 mg po weekly is recommended as first line prophylaxis for Mycobacterium avium complex (MAC) in patients with HIV infection whose CD4 counts are <50 cells/microL. HIV-infected patients with CD4+ T-cell counts <200 cells/microL were randomized to receive either clarithromycin 500 mg po bid or azithromycin 1200 mg po weekly for 12 weeks. Nasopharyngeal swabs for Streptococcus pneumoniae and Haemophilus influenzae plus an anterior nare culture for Staphylococcus aureus were obtained at pretreatment, at 6 weeks, and at 12 weeks. A throat culture for oral flora was obtained for susceptibility testing against erythromycin. Minimum inhibitory concentrations (MICs) for clarithromycin and azithromycin were performed on all S. pneumoniae, H. influenzae, and S. aureus isolates. The study was terminated after respiratory flora, from all participants, revealed macrolide resistance. Because results of recent randomized trials indicate minimal efficacy of continuing MAC prophylaxis in patients who respond to potent combination antiretroviral therapy, the observed high incidence of macrolide-resistant bacterial colonization of the respiratory tract in this trial supports the discontinuation of macrolide prophylaxis in all AIDS patients whose CD4 counts have risen above 100 cells/microL
— id: 47072, year: 2001, vol: 2, page: 453, stat: Journal Article,

Sex differences in nevirapine rash
Bersoff-Matcha SJ; Miller WC; Aberg JA; van Der Horst C; Hamrick Jr HJ; Powderly WG; Mundy LM
2001 Jan;32(1):124-129, Clinical infectious diseases
Nevirapine is a nonnucleoside reverse transcriptase inhibitor (NNRTI) that has the most common treatment limiting side effect of rash. Severe rash has been observed in 3% of patients taking nevirapine in clinical trials, 85% of whom were men. In a multicenter, retrospective cohort study of all patients who received nevirapine over a 5-year period, severe rash was noted in 9 of 95 women and 3 of 263 men (risk ratio [RR], 8.31; 95% confidence interval [CI], 2.3-30.0; P=.005). Women were more likely to discontinue nevirapine therapy because of rash (RR, 4.5; 95% CI, 1. 9-10.5; P=.0005). After adjusting for age and baseline CD4 cell count in multivariate analysis, women had a 7-fold increase in risk for severe rash and were 3.5 times more likely to discontinue nevirapine therapy. In women of reproductive age for whom contraception may occur, nevirapine remains the NNRTI of choice. Recognition of sex differences in this severe adverse event will be important in prescribing nevirapine
— id: 47076, year: 2001, vol: 32, page: 124, stat: Journal Article,

Invasive fungal sinusitis and meningitis due to Arthrographis kalrae in a patient with AIDS
Chin-Hong PV; Sutton DA; Roemer M; Jacobson MA; Aberg JA
2001 Feb;39(2):804-807, Journal of clinical microbiology
We report the first described case of Arthrographis kalrae pansinusitis and meningitis in a patient with AIDS. The patient was initially diagnosed with Arthrographis kalrae pansinusitis by endoscopic biopsy and culture. The patient was treated with itraconazole for approximately 5 months and then died secondary to Pneumocytis carinii pneumonia. Postmortem examination revealed invasive fungal sinusitis that involved the sphenoid sinus and that extended through the cribiform plate into the inferior surfaces of the bilateral frontal lobes. There was also an associated fungal meningitis and vasculitis with fungal thrombosis and multiple recent infarcts that involved the frontal lobes, right caudate nucleus, and putamen. Post mortem cultures were positive for A. kalrae
— id: 47075, year: 2001, vol: 39, page: 804, stat: Journal Article,

HIV and cardiovascular risk factors
Falusi OM; Aberg JA
2001 May;11(5):263-268, AIDS reader
There is growing concern that the metabolic complications associated with HIV and antiretroviral therapy may lead to accelerated coronary artery disease (CAD). Traditional cardiovascular risk factors, such as hypertension, hyperlipidemia, diabetes mellitus, and visceral fat accumulation, are increasingly seen in HIV patients receiving HAART. These factors are in addition to nonreversible risk factors, such as male sex, age greater than 40 years, and family history of premature CAD. Patients may also be smokers and may have a sedentary lifestyle, both of which predispose to significant CAD. In older patients and those with other risk factors, there may be an accentuation of these risk factors by HAART, although these factors also occur in young patients with no other risk factors. It is still unknown whether the factors predispose HIV patients to accelerated cardiovascular disease. Short-term studies, including 2 large cross-sectional studies, do not show an increased risk of cardiovascular complications or cardiac death, but longer follow-up is needed to answer such questions effectively. Even if patients are not at increased risk for cardiovascular disease, they are at least at the same risk as HIV-negative, age-matched persons with similar risk factors. It is, therefore, pertinent to identify and effectively manage those risk factors that can be modified
— id: 47074, year: 2001, vol: 11, page: 263, stat: Journal Article,

Reconstitution of immunity against opportunistic infections in the era of potent antiretroviral therapy
Aberg JA
2000 01;133(7):115-138, AIDS clinical review
Critical questions remain unanswered regarding the safety and efficacy of withdrawing primary and secondary prophylaxis in the context of HAART-associated immune reconstitution. What are the mediators of first phase cellular increases? Will continued HIV suppression result in continued immune restoration? And what are the immunological consequences of viral rebound despite HAART in patients whose CD4 counts remain elevated? Can immunity, once lost, be restored by reintroduction of antigens such as by tetanus or pneumococcal vaccination? Can immunoassays predict who will relapse or reactivate an OI? Is it possible to eradicate infections such as MAC, cryptococcosis, and histoplasmosis? Certainly, one can never eradicate CMV infection but can immunoassays predict who will have disease-reactivate? Unfortunately, various studies have reported contradicting results regarding the immunological response in vitro to specific antigens. Until these immunoassays become standardized and validated, it is unclear if immunoassays will be predictive of who would be at risk of development of disease or relapse. Therefore, until such time, clinicians may want to initiate and maintain primary prophylaxis in HIV-infected individuals as recommended by the USPHS/IDSA guidelines based on the nadir CD4+ T-cell count at least until studies have clearly demonstrated whether the increased CD4+ T-cell response attributed to HAART does in fact confer protection against these pathogens. Although for some OIs it does appear safe to withdraw primary prophylaxis and probably secondary prophylaxis, the decision to stop prophylaxis or maintenance therapy should be a joint decision by the patient and clinician based on the risks and benefits of stopping the therapy and the availability of close clinical monitoring for evidence of disease
— id: 47079, year: 2000, vol: 133, page: 115, stat: Journal Article,

Clinical utility of monitoring serum cryptococcal antigen (sCRAG) titers in patients with AIDS-related cryptococcal disease
Aberg JA; Watson J; Segal M; Chang LW
2000 Jul-Aug;1(1):1-6, HIV clinical trials
PURPOSE: The purpose of our study was to define the time course and clinical role of monitoring serum cryptococcal antigen titers (sCRAG) in patients with AIDS-related cryptococcal disease. METHOD: A retrospective chart review was conducted. The medical records for all HIV-infected patients with positive cryptococcal antigen (CRAG) tests from January 1993 to May 1998 at San Francisco General Hospital (SFGH) were reviewed for sCRAG titer levels and clinical outcomes. RESULTS: Out of the 314 patients found to have positive antigen tests, 136 met the inclusion criteria. Twelve (8.8%) had no change in titer from baseline, 6 (4.4%) had an increase, and 118 (86.8%) had a decrease. Examining the association of sCRAG with time to relapse using a variety of Cox models produced largely null results. Rate of change in sCRAG over time (slope) was not significantly predictive of time to relapse nor of time to definite relapse/probable relapse/persistent disease. CONCLUSION: Although in the majority of patients, the sCRAG titers appeared to decrease over time, we could not detect a significant correlation between sCRAG titer results of patients who had a clinical response to treatment and sCRAG titers in patients who experienced persistent disease, probable relapse, or definitive relapse of cryptococcal disease. We conclude that follow-up monitoring of the sCRAG titer is not useful in the management of patients with AIDS-related cryptococcal disease on treatment
— id: 47073, year: 2000, vol: 1, page: 1, stat: Journal Article,

Discontinuation of Mycobacterium avium complex prophylaxis in patients with antiretroviral therapy-induced increases in CD4+ cell count. A randomized, double-blind, placebo-controlled trial. AIDS Clinical Trials Group 362 Study Team
Currier JS; Williams PL; Koletar SL; Cohn SE; Murphy RL; Heald AE; Hafner R; Bassily EL; Lederman HM; Knirsch C; Benson CA; Valdez H; Aberg JA; McCutchan JA
2000 Oct 3;133(7):493-503, Annals of internal medicine
BACKGROUND: Patients infected with HIV who experience increases in CD4(+) cell counts are at reduced risk for opportunistic infections. However, the safety of discontinuing prophylaxis against Mycobacterium avium complex has been uncertain. OBJECTIVE: To compare the rate of M. avium complex infection in patients with increased CD4(+) cell counts who receive azithromycin and those receiving placebo. DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: 29 university-based clinical centers in the United States. PARTICIPANTS: 643 HIV-1-infected patients with a previous CD4(+) cell count less than 0.05 x 10(9) cells/L and a sustained increase to greater than 0.10 x 10(9) cells/L during antiretroviral therapy. INTERVENTION: Azithromycin, 1200 mg once weekly (n = 321), or matching placebo (n = 322). MEASUREMENTS: Mycobacterium avium complex cultures, CD4(+) cell counts, and clinical evaluations for AIDS-defining illnesses and bacterial infections were done every 8 weeks. Plasma HIV-1 RNA levels were measured at 16-week intervals. RESULTS: During follow-up (median, 16 months), 2 cases of M. avium complex infection were reported among the 321 patients assigned to placebo (incidence rate, 0.5 event per 100 person-years [95% CI, 0.06 to 1.83 events per 100 person-years]) compared with no cases among the 322 patients assigned to azithromycin (CI, 0 to 0.92 events per 100 person-years), resulting in a treatment difference of 0.5 event per 100 person-years (CI, -0.20 to 1.21 events per 100 person-years) for placebo versus azithromycin. Both cases were atypical in that M. avium complex was localized to the vertebral spine. Patients receiving azithromycin were more likely than those receiving placebo to discontinue treatment with the study drug permanently because of adverse events (8% vs. 2%; hazard ratio, 0.24 [CI, 0.10 to 0.57]). CONCLUSIONS: Prophylaxis against Mycobacterium avium complex can safely be withdrawn or withheld in adults with HIV infection who experience increases in CD4(+) cell count while receiving antiretroviral therapy
— id: 47078, year: 2000, vol: 133, page: 493, stat: Journal Article,

Preliminary guidelines for the evaluation and management of dyslipidemia in adults infected with human immunodeficiency virus and receiving antiretroviral therapy: Recommendations of the Adult AIDS Clinical Trial Group Cardiovascular Disease Focus Group
Dube MP; Sprecher D; Henry WK; Aberg JA; Torriani FJ; Hodis HN; Schouten J; Levin J; Myers G; Zackin R; Nevin T; Currier JS
2000 Nov;31(5):1216-1224, Clinical infectious diseases
Dyslipidemia is a prevalent condition that affects patients infected with human immunodeficiency virus (HIV) who are receiving antiretroviral therapy. These preliminary recommendations summarize the current understanding in this area and propose guidelines for management. Existing guidelines for the management of dyslipidemia in the general population formed the general basis for our recommendations. Data on the prevalence and treatment of dyslipidemia of HIV-infected patients, implications of treatment-related dyslipidemia in other chronically ill populations, and pharmacokinetic profiles for the available hypolipidemic agents in non-HIV populations were considered. Although the implications of dyslipidemia in this population are not fully known, the frequency, type, and magnitude of lipid alterations in HIV-infected people are expected to result in increased cardiovascular morbidity. We propose that these patients undergo evaluation and treatment on the basis of existing guidelines for dyslipidemia, with the caveat that avoidance of interactions with antiretroviral agents is paramount
— id: 47077, year: 2000, vol: 31, page: 1216, stat: Journal Article,

Pulmonary cryptococcosis in patients without HIV infection
Aberg JA; Mundy LM; Powderly WG
1999 Mar;115(3):734-740, Chest
PURPOSE: To further elucidate the diagnostic and therapeutic approaches to patients with pulmonary cryptococcosis who are not HIV-infected. SUBJECTS: All of the patients without HIV infection who received care at two Midwest hospitals between January 1986 and February 1996 and had a respiratory isolate of Cryptococcus neoformans. METHODS: The medical records of the study patients were reviewed for demographic data, host immune status, respiratory symptoms, diagnostic studies, treatment, and follow-up. RESULTS: Forty-two patient presentations comprised the overall study group. Thirty-six patients (85.7%) had no evidence of dissemination, and six patients (14.3%) had disseminated disease. Seven of the 36 patient presentations were definitive pulmonary cryptococcosis, 15 were presumptive disease, and 14 were colonization with C neoformans. Neither the baseline demographic parameters nor the immune status appeared to discriminate the patients with disease from the patients with colonization. A serum cryptococcal antigen (sCRAG) was positive for 7 of 18 patients, 3 of whom were proven by culture to have a disseminated infection. A negative sCRAG was observed in 11 patients, one of whom had proven dissemination. Fifteen patients underwent a lumbar puncture as part of their evaluation, and cryptococcal meningitis was diagnosed in three of these patients, all of whom had positive blood cultures for C neoformans. The majority of the patients did not receive antifungal therapy. CONCLUSION: In the majority of the patients, the lung appeared to be the sole organ involved, and a workup for systemic infection was rarely helpful. A positive sCRAG was not specific for dissemination. Antifungal therapy should be reserved for symptomatic patients, for patients with a positive sCRAG, and for patients with underlying immunosuppression
— id: 47080, year: 1999, vol: 115, page: 734, stat: Journal Article,

The San Francisco General Hospital handbook of HIV management : the practical management of HIV-infected patients
Volberding, Paul; Aberg, Judith A; Cohen, PT
New York NY : Parthenon, 1999,
— id: 2161, year: 1999, vol: , page: , stat: ,

Eradication of AIDS-related disseminated mycobacterium avium complex infection after 12 months of antimycobacterial therapy combined with highly active antiretroviral therapy
Aberg JA; Yajko DM; Jacobson MA
1998 Nov;178(5):1446-1449, Journal of infectious diseases
To determine if microbiologic cure of AIDS-related disseminated Mycobacterium avium complex (MAC) is possible in patients receiving highly active antiretroviral therapy (HAART), 4 patients with a history of disseminated MAC received >/=12 months of macrolide-based antimycobacterial therapy. All were asymptomatic and had absolute CD4 cell count >100/microL (range, 137-301) and <10,000 copies/mL of human immunodeficiency virus RNA (range, <500-1250). A bone marrow aspirate and peripheral blood were obtained for mycobacterial culture. Follow-up blood cultures were obtained routinely at 4 weeks and every 8 weeks thereafter. All 4 patients had negative bone marrow and blood cultures and then discontinued antimycobacterial therapy. All patients' subsequent cultures remain sterile and all are clinically asymptomatic (range, 8-13 months follow-up). It appears that disseminated MAC infection can be cured by prolonged antimycobacterial therapy in some persons who experience sustained CD4 lymphocyte increases while receiving HAART
— id: 47081, year: 1998, vol: 178, page: 1446, stat: Journal Article,

Drug information handbook for dentistry
Wynn, Richard L; Meiller, Timothy F; Crossley, Harold L; Aberg, Judith A
Hudson OH : Lexi-Comp, 1998,
— id: 2157, year: 1998, vol: , page: , stat: ,

Cryptococcal disease: implications of recent clinical trials on treatment and management
Aberg JA; Powderly WG
1997 98;178(5):229-248, AIDS clinical review
— id: 47082, year: 1997, vol: 178, page: 229, stat: Journal Article,

Cryptococcosis
Aberg JA; Powderly WG
1997 ;37(5):215-251, Advances in pharmacology (New York)
— id: 47083, year: 1997, vol: 37, page: 215, stat: Journal Article,

Idiopathic hypoparathyroidism in a blind, deaf, elderly woman with dementia
Aberg JA; Gorbien MJ
1996 May-Jun;63(3):156-160, Cleveland Clinic journal of medicine
— id: 47084, year: 1996, vol: 63, page: 156, stat: Journal Article,

Immunoglobulin G immunosuppression of multiple sclerosis. Suppression of all three major lymphocyte subsets
Tenser RB; Hay KA; Aberg JA
1993 Apr;50(4):417-420, Archives of neurology
Six patients with relapsing chronic progressive multiple sclerosis were treated on 2 consecutive days with large amounts of IgG to induce immunosuppression. Peripheral blood lymphocyte subsets were monitored for 5 weeks after IgG treatment to determine immunosuppression. Decreased numbers of B, T, and natural killer lymphocytes were detected after treatment. Lymphocyte numbers were at a nadir 1 week after treatment, but an immunosuppressive effect continued to be present after 5 weeks. Although clinical efficacy was not evident in this brief open trial, the decrease of peripheral lymphocyte numbers and the apparent safety of the procedure warrant further study
— id: 47085, year: 1993, vol: 50, page: 417, stat: Journal Article,

Prostaglandin production in chronic progressive multiple sclerosis
Aberg JA; Demers LM; Romano PJ; Tenser RB
1990 ;4(4):246-250, Journal of clinical laboratory analysis
Peripheral blood monocytes have been implicated in the immune reactions that accompany demyelination in patients with multiple sclerosis (MS). We measured prostaglandin E2 (PGE2) and thromboxane B2 (TxB2) release from peripheral monocytes exposed in vitro to complement. Our studies suggest that there is a significantly higher production of PGE2 in monocytes from patients with chronic progressive MS than in those with exacerbation or remitting MS and healthy controls. No significant differences in TxB2 release were noted between the three groups
— id: 47086, year: 1990, vol: 4, page: 246, stat: Journal Article,