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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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).

Key facts

Study ID

NCT00000949

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

460

Expected to finish

2000-07-01

Last updated by the study team

2021-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Community Consortium / UCSF — San Francisco, California, United States
• Denver CPCRA / Denver Public Hlth — Denver, Colorado, United States
• Washington Reg AIDS Prog / Dept of Infect Dis — Washington D.C., District of Columbia, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• AIDS Research Alliance - Chicago — Chicago, Illinois, United States
• Louisiana Comm AIDS Rsch Prog / Tulane Univ Med — New Orleans, Louisiana, United States
• Wayne State Univ - WSU/DMC / Univ Hlth Ctr — Detroit, Michigan, United States
• Henry Ford Hosp — Detroit, Michigan, United States
• Southern New Jersey AIDS Clinical Trials — Camden, New Jersey, United States
• North Jersey Community Research Initiative — Newark, New Jersey, United States
• Partners in Research / New Mexico — Albuquerque, New Mexico, United States
• Harlem AIDS Treatment Grp / Harlem Hosp Ctr — New York, New York, United States
• The Research and Education Group — Portland, Oregon, United States
• Philadelphia FIGHT — Philadelphia, Pennsylvania, United States
• Richmond AIDS Consortium / Div of Infect Diseases — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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