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A5212 - A Double Blind Phase II Study of Multiple Doses of Palifermin (rHuKGF) for the Treatment of Inadequate CD4+ Lymphocyte Recovery in Subjects on Potent Antiretroviral Therapy with Plasma HIV-1 RNA Levels ≥200 copies/mL.
Eligible candidates:
- have an HIV viral load =200 for at least 6 months.
- have CD4+ T cells <200 at screening (30 days prior to study entry.)
- must be on at least three antiretroviral medications for 6 months or greater.
- Additional requirements will be discussed by the study nurse or doctor.
Study Objective:
This study will be done at several sites around the country. Its purpose is to find out if the
study drug, palifermin (recombinant Human Keratinocyte Growth Factor) is able to increase CD4+ T
cell counts (a measure of your immune system) by increasing production of these cells in the
thymus gland that is located at the base of the neck. The study will use three different doses
of palifermin in order to see which dose causes the greatest increase of CD4+ T cells to be
produced from the thymus gland. There will also be a placebo group used to see if there is a
greater rise in CD4+ T cell counts in at least one of the three palifermin dose groups when
compared to the placebo group.
Study Scheme:
96 subjects will be randomized to one of four arms, with 24 subjects per arm:
- Arm A: Palifermin placebo IV bolus daily for 3 days
- Arm B: Palifermin 20 mcg/kg IV bolus daily for 3 days
- Arm C: Palifermin 40 mcg/kg IV bolus daily for 3 days
- Arm D: Palifermin 60 mcg/kg IV bolus daily for 3 days
Participants will be followed on study for 24 weeks after the completion of the palifermin treatment.
Study Drugs:
- Palifermin
Study Status: Closed to Enrollment.
Study Staff:
- Judith Aberg, MD
- Karen Cavanagh, RN
- Luis Vargas
Study Sponsors:
- AIDS Clinical Trials Group (NIH)
Study Volunteers Receive:
- Cost-free lab work
- Transportation reimbursement