Interleukin-2 (IL-2) Treatment for HIV Infected Patients Who Have Interrupted Their Anti-HIV Drug Therapy
An Exploratory, Open-Label, Randomized Trial to Evaluate the Ability of Interleukin-2 (IL-2) to Enhance HIV-Specific Immunity and Influence the Time to Virologic Relapse Following Withdrawal of Potent Antiretroviral Therapy
2 other identifiers
interventional
21
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv-infections
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2002
CompletedFirst Posted
Study publicly available on registry
May 30, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedNovember 1, 2021
October 1, 2021
May 29, 2002
October 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean of log10 HIV-1 RNA copies/ml obtained at Weeks 11 and 12 following the final interruption of potent antiretroviral therapy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
UCLA CARE Center CRS
Los Angeles, California, 90502, United States
Stanford CRS
Palo Alto, California, 94305-5107, United States
UC Davis Medical Center
Sacramento, California, 95814, United States
Univ. of California Davis Med. Ctr., ACTU
Sacramento, California, 95814, United States
Santa Clara Valley Med. Ctr.
San Jose, California, 94305-5107, United States
San Mateo County AIDS Program
San Mateo, California, 94305-5107, United States
Univ. of Miami AIDS CRS
Miami, Florida, 33136-1013, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816, United States
MetroHealth CRS
Cleveland, Ohio, United States
Univ. of Texas Medical Branch, ACTU
Galveston, Texas, 775550435, United States
Related Publications (6)
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.
PMID: 9806026BACKGROUNDKovacs 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.
PMID: 7646637BACKGROUNDKovacs 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.
PMID: 8857018BACKGROUNDLafeuillade 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.
PMID: 14624367BACKGROUNDPett 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.
PMID: 15482104BACKGROUNDBosch 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.
PMID: 21291323DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Richard M. Pollard, MD
University of California, Davis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2002
First Posted
May 30, 2002
Study Completion
May 1, 2006
Last Updated
November 1, 2021
Record last verified: 2021-10