A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients With CD4 Counts Greater Than 300 Cells/mm3

A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients With CD4 Counts Greater Than 300 Cells/mm3

A Randomized, Open-Label, Study of the Impact of Two Doses of Subcutaneous Recombinant IL-2 (Proleukin) on Viral Burden and CD4+ Cell Count in Patients With HIV-1 Infection and CD4+ Cell Counts Greater Than or Equal to 300/mm3

The purpose of this study is to examine how rIL-2 affects HIV-positive patients with CD4 counts over 300 cells/mm3 who are on anti-HIV drug therapy. The drug rIL-2 has been shown to increase CD4 cell counts, which help the body fight off HIV. There is strong evidence that rIL-2 increases CD4 cell counts (cells of the immune system that fight infection). This study examines the effect of 2 different amounts of rIL-2 on CD4 cell count and the amount of HIV in the blood (viral burden).

There is substantial evidence that rIL-2 increases CD4+ cell count. Whether or not rIL-2 delays progression to AIDS and extends survival is currently unknown, such clinical benefits of rIL-2 can only be established in a large, long-term, randomized trial. This study examines the effect of two different rIL-2 doses on HIV viral burden and CD4+ cell count and provides additional information on optimal dosing, safety, and antiviral activity of rIL-2. Patients are randomized to receive one of two subcutaneous (sc) doses of recombinant rIL-2 or no rIL-2. Those patients who take rIL-2 initially receive three courses of treatment. For this study, a course is defined as eight calendar weeks, including the five-day period of sc rIL-2 administration. Additional courses are given (no more frequently than every 6 weeks) in order to maintain a CD4+ count of at least twice its baseline level or at least 1,000 cells/mm3. Follow-up will continue for all patients until a common closing date of 12 months following enrollment of the last patient.

AIDS-Related Opportunistic Infections, Interleukin-2, Dose-Response Relationship, Drug, Adolescent Behavior, CD4 Lymphocyte Count, RNA, Viral, Quality of Life, Anti-HIV Agents, Viral Load

Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Agree to practice abstinence or use effective birth control methods during the study. Are on anti-HIV therapy and have a CD4 count of at least 300 cells/mm3. Are at least 18 years old. Exclusion Criteria You will not be eligible for this study if you: Have a history of progressive diseases. Have a history of severe autoimmune/inflammatory disease. Have Crohn's disease. Are taking antiseizure medications or certain other medications. Are receiving chemotherapy. Are pregnant or breast-feeding. Have ever received rIL-2.

Abrams DI, Bebchuk JD, Denning ET, Davey RT, Fox L, Lane HC, Sampson J, Verheggen R, Zeh D, Markowitz NP; Terry Beirn Community Programs for Clinical Research on AIDS. Randomized, open-label study of the impact of two doses of subcutaneous recombinant interleukin-2 on viral burden in patients with HIV-1 infection and CD4+ cell counts of > or = 300/mm3: CPCRA 059. J Acquir Immune Defic Syndr. 2002 Mar 1;29(3):221-31. doi: 10.1097/00126334-200203010-00002.