CLINICAL TRIAL: PALIFERMIN (FHUKGF) FOR THE TREATMENT OF INADEQUATE CD4 & LUMPHO

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Purpose: This study will look at whether one type of growth factor, palifermin (rHuKGF), a substance that promotes growth and especially cell growth, can safely increase your CD4+ cell count. This will be done by comparing three different doses of palifermin to placebo (an inactive pill, liquid, or powder that has no treatment value). Participants: HIV-1-infected Men and women age greater than or equal to 18 years. Procedures (methods): To maintain study product blinding, each subject will receive three IV bolus doses of palifermin or palifermin placebo on each of 3 consecutive days: day 1 (Entry), day 2, and day 3. Subjects will be followed on study for a total of 24 weeks. Subjects must receive potent ART for the duration of the trial. ART will not be provided through A5212.