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).

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Aldesleukin	Phase III

Further Study Details: 

Expected Total Enrollment:  460

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

California
      Community Consortium / UCSF, San Francisco,  California,  94110,  United States
Colorado
      Denver CPCRA / Denver Public Hlth, Denver,  Colorado,  802044507,  United States
District of Columbia
      Washington Reg AIDS Prog / Dept of Infect Dis, Washington,  District of Columbia,  20422,  United States
Georgia
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  303081962,  United States
Illinois
      AIDS Research Alliance - Chicago, Chicago,  Illinois,  60657,  United States
Louisiana
      Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans,  Louisiana,  70112,  United States
Michigan
      Henry Ford Hosp, Detroit,  Michigan,  48202,  United States
      Wayne State Univ - WSU/DMC / Univ Hlth Ctr, Detroit,  Michigan,  48201,  United States
New Jersey
      North Jersey Community Research Initiative, Newark,  New Jersey,  071032842,  United States
      Southern New Jersey AIDS Clinical Trials, Camden,  New Jersey,  08103,  United States
New Mexico
      Partners in Research / New Mexico, Albuquerque,  New Mexico,  87131,  United States
New York
      Harlem AIDS Treatment Grp / Harlem Hosp Ctr, New York,  New York,  10037,  United States
Oregon
      The Research and Education Group, Portland,  Oregon,  97210,  United States
Pennsylvania
      Philadelphia FIGHT, Philadelphia,  Pennsylvania,  19107,  United States
Virginia
      Richmond AIDS Consortium / Div of Infect Diseases, Richmond,  Virginia,  232980049,  United States

Study chairs or principal investigators

Donald I. Abrams,  Study Chair
Norman Markowitz,  Study Chair

Study ID Numbers:  CPCRA 059
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000949
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08