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

• Status: Completed
• Trial end date: 2000-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Aldesleukin

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.