The Primary HIV Infection Study
at the NYU Center for AIDS Research in New York City

The goal of the Primary HIV Infection Study is to identify and study people with acute or recent HIV infection. Volunteers may elect to be followed in one of two arms: a treatment trial or an observational arm in which no medications are used. Having a better understanding of the changes that occur in people with recent and acute HIV infection will allow us to create more effective vaccines and medications for the treatment and prevention of HIV infection.

People who are concerned about the possible early symptoms of an HIV infection should contact First Call NYU for more information.

Patient Poulation
Men and women age 18 and over who are found to have acute or recent HIV infection.
In order to be eligible for this study, volunteers must fall into one of the following categories:

• Acute HIV infection determined by detectable plasma HIV viral load >2,000 copies and one of the following:
  • Negative ELISA Test
  • Positive ELISA plus negative or indeterminate Western Blot
  • Positive ELISA and Western Blot but documented previous negative ELISA within the past 30 days.
• Recent HIV infection is determined by only one of the following:
  • Positive ELISA and Western Blot and documented negative ELISA within 31 to 120 days.
  • Positive ELISA and Western Blot with non-reactive detuned ELISA and CD4 count greater than 200.
• Early-established infection meeting all of the following criteria within 14 days of study entry.
  • Documented negative ELISA within 18 months prior to study entry
  • Positive ELISA and Western Blot, and
  • Plasma viral load of >2,000 copies/mL

Study Objective
The objective of the study overall is to learn more about recent and acute HIV infection and the changes that occur in the weeks and months after someone is first infected with HIV.
The objective of the treatment trial is to determine how well volunteers with acute and recent infection control HIV after an initial course of HIV treatment medication.

Study Scheme
All volunteers must have an acute or recent HIV infection or meet the criteria for the Early Established category. Volunteers elect to participate in one of these arms:

• Arm 1 - A treatment trial including standard antiretrovial (anti-HIV) therapy. Volunteers may receive medications provided by the study or may choose an approved regimen with the help of their primary care doctor. Alternative regimens will not be provided by the study.
• Arm 2 - An observational study in which participants are closely followed, but take no medications.

Study-provided medications include:

• Ritonavir, RTV
• Tenofovir
• FTC, Emtricitabine, Coviracil
• ATV

For more information, please call 212-263-3544.

Study Status: Active Study, Open for Enrollment

Study Staff:

• Fred Valentine, MD
• Demetre Daskalakis, MD
• Robert Hagerty
• Richard Hutt
• Margie Vasquez, RN

Study Sponsors:

• NIH

Study Volunteers Receive:

• The opportunity to contribute to our understanding of acute/recent HIV
• Current standard of care suppressive antiretrovial medications provided through the study
• Cost-free lab work
• Transportation reimbursement