When an HIV infected person taking strong anti-HIV drugs temporarily stops taking them, viral load rises and the body's immune system is exposed to more HIV. This may lead to the body mounting a better immune response against the virus. The purpose of this study is to find out if taking interleukin-2 (also called IL-2 or aldesleukin) while stopping anti-HIV drugs for short periods of time can help patients control their HIV viral load.

Study hypothesis: Patients in this study will have lower virologic rebound and will maintain their CD4 cell counts for a longer time than other patients in comparative studies.

Condition	Treatment or Intervention
HIV Infections	Drug: Aldesleukin

Further Study Details: 

Primary Outcomes: Mean of log10 HIV-1 RNA copies/ml obtained at Weeks 11 and 12 following the final interruption of potent antiretroviral therapy
Expected Total Enrollment:  21

Structured treatment interruptions (STIs) may stimulate an anti-HIV immune response. Evidence suggests that IL-2, which increases CD4 counts, could also enhance specific immune responses to HIV. Enhanced immune responses could influence the magnitude of and the time to virologic rebound following treatment discontinuation. This study will compare the viral loads present after 12 weeks of an antiretroviral therapy (ART) interruption period between patients who have received different dosing regimens of IL-2 and have taken part in at least two STIs.

This study will last 40 to 104 weeks. IL-2 is provided as part of this study; potent ART is not provided. Patients in this study will receive potent ART with at least two scheduled potent ART interruptions. Patients will be randomly assigned to one of two treatment arms. Arm A patients will receive low dose injections of IL-2 for 3 weeks, during the last 2 weeks of potent ART interruption periods and the first week of restarting potent ART. Arm B patients will receive high dose injections of IL-2 during the first 5 days of restarting potent ART after the interruption period. The first two ART interruptions are 4 weeks in duration, followed by 12 weeks back on ART. Depending on the patient's viral load and CD4 count at Week 32, patients will either enter a third potent ART interruption for 12 to 48 weeks or will continue ART. No IL-2 will be given with the third scheduled potent ART interruption. Throughout the study, participants will have physical exams and laboratory tests, including measurements of viral load and CD4 count.

Genders Eligible for Study:  Both

Criteria

Note: ACTG A5132 closed to accrual on 11/01/04.

Inclusion Criteria:

• HIV infected
• CD4 cell count of 300 cells/mm3 or more within 30 days prior to study entry
• HIV viral load of less than 50 copies/ml within 30 days prior to study entry
• Anti-HIV drug regimen of at least 3 anti-HIV drugs for at least 6 months immediately prior to study entry
• Documented pretherapy plasma HIV viral load measured within 6 months of starting ART
• Willing to use acceptable methods of contraception

Exclusion Criteria:

• HIV viral load of 50 copies/ml or more within 60 days before study entry
• Current use of experimental anti-HIV drugs other than FDA sanctioned investigational drugs
• Abacavir as part of anti-HIV regimen within 8 weeks prior to study entry
• Pregnant or breastfeeding
• History of autoimmune disease, except for stable autoimmune thyroid disease
• Heart problems or on certain medications for treatment of heart problems
• Cancer requiring chemotherapy
• Untreated thyroid disease
• Disease of the central nervous system that has been active within 1 year prior to study entry
• Uncontrolled diabetes
• Allergies to the study medications
• Other illnesses that would make it inappropriate for patients to participate in the study
• Immunomodulatory therapy within 4 weeks prior to study entry
• Hydroxyurea within 6 months prior to study entry
• Drug or alcohol use that, in the opinion of the investigator, would interfere with the study
• Psychiatric or mental impairment that would affect compliance

Alabama
      Univ of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States
California
      Stanford Univ Med Ctr, Stanford,  California,  943055107,  United States
      UCLA CARE Ctr, Los Angeles,  California,  90095,  United States
      Univ of Southern California / LA County USC Med Ctr, Los Angeles,  California,  900331079,  United States
      Harbor UCLA Med Ctr, Torrance,  California,  90502,  United States
      Stanford Univ, Stanford,  California,  94305-5107,  United States
      Willow Clinic, Stanford,  California,  94305-5107,  United States
      San Mateo County AIDS Program, Stanford,  California,  94305-5107,  United States
      Santa Clara Valley Med Ctr, Stanford,  California,  94305-5107,  United States
      Univ of California, Davis Med Ctr, Sacramento,  California,  95814,  United States
      UC Davis Med Ctr, Sacramento,  California,  95814,  United States
Colorado
      Univ of Colorado Health Sciences Ctr, Denver,  Colorado,  80262,  United States
Florida
      University of Miami, Miami,  Florida,  33136-1013,  United States
Hawaii
      Queens Med Ctr, Honolulu,  Hawaii,  96816,  United States
      Univ of Hawaii, Honolulu,  Hawaii,  96816,  United States
Iowa
      Univ of Iowa Hosp and Clinic, Iowa City,  Iowa,  52242,  United States
Louisiana
      Tulane Univ School of Medicine, New Orleans,  Louisiana,  70112,  United States
Massachusetts
      Beth Israel Deaconess - West Campus, Boston,  Massachusetts,  02215,  United States
Missouri
      St Louis Regional Hosp / St Louis Regional Med Ctr, St. Louis,  Missouri,  63112,  United States
New York
      Univ of Rochester Medical Center, Rochester,  New York,  14642,  United States
      Bellevue Hosp / New York Univ Med Ctr, New York,  New York,  10016,  United States
      Mount Sinai Med Ctr, New York,  New York,  10029,  United States
      Cornell Univ Med Ctr, New York,  New York,  10021,  United States
      Beth Israel Med Ctr, New York,  New York,  10003,  United States
North Carolina
      Univ of North Carolina, Chapel Hill,  North Carolina,  275997215,  United States
      Duke Univ Med Ctr, Durham,  North Carolina,  27710,  United States
Ohio
      Case Western Reserve Univ, Cleveland,  Ohio,  44106,  United States
      Ohio State Univ Hosp Clinic, Columbus,  Ohio,  432101228,  United States
South Carolina
      Julio Arroyo, West Columbia,  South Carolina,  29169,  United States
Texas
      Univ of Texas Galveston, Galveston,  Texas,  775550435,  United States
Washington
      Univ of Washington, Seattle,  Washington,  98104,  United States

Study chairs or principal investigators

Richard M. Pollard, MD,  Study Chair,  University of California, Davis   

Study ID Numbers:  ACTG A5132
Record last reviewed:  February 2005
Last Updated:  April 7, 2005
Record first received:  May 29, 2002
ClinicalTrials.gov Identifier:  NCT00038259
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08