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.

Purpose of this Study: To find out if the study drug, palifermin is able to increase CD4+ T cell counts by increasing production of these cells in the thymus gland.

Requirements to Enter Study:

HIV-1 positive with a viral load <=200 for at least 6 months
CD4+ T cells should be <200 at screening (30 days prior to study entry)
Participant should be on at least three antiretroviral medications for 6 months or greater

Treatment: Subjects will be randomized to one of four arms:

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

Duration of Study: Participants will be followed on study for 24 weeks after the completion of the palifermin treatment.

For more information contact:

Study Contacts
Kathryn Maffei, RN (215) 349-8092