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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility 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.

Trial Officials