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

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Drug: Aldesleukin

Study type: Interventional

Funder types: NIH

Identifiers

NCT00000949

CPCRA 059

11615 (Registry Identifier)

Details and patient eligibility

About

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).

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.