Interleukin-2 (IL-2) Treatment for HIV Infected Patients Who Have Interrupted Their Anti-HIV Drug Therapy
NCT ID: NCT00038259
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2006-05-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Aldesleukin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Richard M. Pollard, MD
Role: STUDY_CHAIR
University of California, Davis
Locations
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UCLA CARE Center CRS
Los Angeles, California, United States
Stanford CRS
Palo Alto, California, United States
UC Davis Medical Center
Sacramento, California, United States
Univ. of California Davis Med. Ctr., ACTU
Sacramento, California, United States
Santa Clara Valley Med. Ctr.
San Jose, California, United States
San Mateo County AIDS Program
San Mateo, California, United States
Univ. of Miami AIDS CRS
Miami, Florida, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States
MetroHealth CRS
Cleveland, Ohio, United States
Univ. of Texas Medical Branch, ACTU
Galveston, Texas, United States
Countries
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References
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Carr A, Emery S, Lloyd A, Hoy J, Garsia R, French M, Stewart G, Fyfe G, Cooper DA. Outpatient continuous intravenous interleukin-2 or subcutaneous, polyethylene glycol-modified interleukin-2 in human immunodeficiency virus-infected patients: a randomized, controlled, multicenter study. Australian IL-2 Study Group. J Infect Dis. 1998 Oct;178(4):992-9. doi: 10.1086/515653.
Kovacs JA, Baseler M, Dewar RJ, Vogel S, Davey RT Jr, Falloon J, Polis MA, Walker RE, Stevens R, Salzman NP, Lane HC. Increases in CD4 T lymphocytes with intermittent courses of interleukin-2 in patients with human immunodeficiency virus infection. A preliminary study. N Engl J Med. 1995 Mar 2;332(9):567-75. doi: 10.1056/NEJM199503023320904.
Kovacs JA, Vogel S, Albert JM, Falloon J, Davey RT Jr, Walker RE, Polis MA, Spooner K, Metcalf JA, Baseler M, Fyfe G, Lane HC. Controlled trial of interleukin-2 infusions in patients infected with the human immunodeficiency virus. N Engl J Med. 1996 Oct 31;335(18):1350-6. doi: 10.1056/NEJM199610313351803.
Lafeuillade A, Poggi C, Hittinger G, Counillon E, Emilie D. Predictors of plasma human immunodeficiency virus type 1 RNA control after discontinuation of highly active antiretroviral therapy initiated at acute infection combined with structured treatment interruptions and immune-based therapies. J Infect Dis. 2003 Nov 15;188(10):1426-32. doi: 10.1086/379251. Epub 2003 Oct 27.
Pett SL, Kelleher AD. Cytokine therapies in HIV-1 infection: present and future. Expert Rev Anti Infect Ther. 2003 Jun;1(1):83-96. doi: 10.1586/14787210.1.1.83.
Bosch RJ, Pollard RB, Landay A, Aga E, Fox L, Mitsuyasu R; AIDS Clinical Trials Group A5132 Team. A randomized trial of interleukin-2 during withdrawal of antiretroviral treatment. J Interferon Cytokine Res. 2011 Jun;31(6):481-3. doi: 10.1089/jir.2010.0119. Epub 2011 Feb 3.
Other Identifiers
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10081
Identifier Type: REGISTRY
Identifier Source: secondary_id
A5132
Identifier Type: -
Identifier Source: org_study_id