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

Phase 3

Completed

• Conditions: HIV Infections

• Registration Number: NCT00000949
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 1999-11-02
• Study Completion: 2000-07
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (15)

Southern New Jersey AIDS Clinical Trials; 🇺🇸 Camden, New Jersey, United States

Washington Reg AIDS Prog / Dept of Infect Dis; 🇺🇸 Washington, District of Columbia, United States

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med; 🇺🇸 New Orleans, Louisiana, United States

Partners in Research / New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

Richmond AIDS Consortium / Div of Infect Diseases; 🇺🇸 Richmond, Virginia, United States

Wayne State Univ - WSU/DMC / Univ Hlth Ctr; 🇺🇸 Detroit, Michigan, United States

The Research and Education Group; 🇺🇸 Portland, Oregon, United States

AIDS Research Consortium of Atlanta; 🇺🇸 Atlanta, Georgia, United States

AIDS Research Alliance - Chicago; 🇺🇸 Chicago, Illinois, United States

North Jersey Community Research Initiative; 🇺🇸 Newark, New Jersey, United States

Philadelphia FIGHT; 🇺🇸 Philadelphia, Pennsylvania, United States

Community Consortium / UCSF; 🇺🇸 San Francisco, California, United States

Denver CPCRA / Denver Public Hlth; 🇺🇸 Denver, Colorado, United States

Harlem AIDS Treatment Grp / Harlem Hosp Ctr; 🇺🇸 New York, New York, United States

Henry Ford Hosp; 🇺🇸 Detroit, Michigan, United States