Treatment With Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328
Treatment Rollover for Subjects Formerly on ACTG 328 With Subcutaneous Interleukin-2 (IL-2) in Combination With Highly Active Antiretroviral Therapy (HAART)
8 other identifiers
interventional
110
1 country
12
Brief Summary
This study examines the long-term effects of interleukin-2 (IL-2) in combination with anti-HIV drugs, or highly active antiretroviral therapy (HAART). The purpose of this study is to see if IL-2 can increase the number of CD4 cells (cells of the immune system which fight infection) in HIV-infected patients who have completed ACTG 328. HAART is often successful in decreasing viral load (level of HIV in the blood), but these drugs have not been able to restore the immune systems of HIV-infected patients. IL-2 is a substance naturally produced by the body's immune cells. In ACTG 328, IL-2 is tested to see if it can increase the number of CD4 cells and "boost" a patient's immune system. This study is a follow-up to ACTG 328 so that patients who are benefiting from IL-2 can continue to take it and patients in the control group who do not receive IL-2 can start taking it.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
12 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
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedMay 21, 2012
May 1, 2012
November 2, 1999
May 17, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Have completed at least 84 weeks of treatment on ACTG 328.
- Have had a 25 percent or greater increase in CD4 cell count above the ACTG 328 Week 11 value (only applies to patients who received IL-2 during ACTG 328).
- Are 18 years of age or older.
- Agree to practice abstinence or use a barrier method of birth control (such as condoms) during the study. (This study has been changed. Hormonal methods of birth control such as birth control pills are no longer allowed.)
You may not qualify if:
- Patients will not be eligible for this study if they:
- Have significant heart disease or are taking certain heart medications. Patients with hypertension who are being treated are eligible.
- Have taken certain medications that might affect the immune system within 4 weeks of study entry including corticosteroids, interferons, or thalidomide.
- Have taken rifampin, rifabutin, or St. John's wort within 7 days of study entry. (This study has been changed. St. John's wort was not in the original version.)
- Are taking certain investigational anti-HIV drugs.
- Are taking indinavir and any of the following within 2 weeks of study entry: cisapride, terfenadine, astemizole, midazolam, triazolam, ketoconazole, itraconazole, or delavirdine.
- Have cancer requiring chemotherapy. Local radiation therapy is allowed.
- Have untreated thyroid disease.
- Are allergic to albumin.
- Have a serious mental illness.
- Have a history of an autoimmune disease, including inflammatory bowel disease and psoriasis.
- Have a central nervous system disease or seizures, if these have been active within 1 year prior to study entry.
- Abuse drugs or alcohol.
- Are pregnant or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Alabama Therapeutics CRS
Birmingham, Alabama, 35294, United States
USC CRS
Los Angeles, California, 900331079, United States
Harbor-UCLA Med. Ctr. CRS
Torrance, California, 90502, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816, United States
Univ. of Iowa Healthcare, Div. of Infectious Diseases
Iowa City, Iowa, 52242, United States
Tulane Univ. A1701 CRS
New Orleans, Louisiana, 70112, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, 63112, United States
Washington U CRS
St Louis, Missouri, United States
Mt. Sinai Med. Ctr. A0404 CRS
New York, New York, 10029, United States
Case CRS
Cleveland, Ohio, 44106, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, 432101228, United States
University of Washington AIDS CRS
Seattle, Washington, 98104, United States
Related Publications (1)
Bosch RJ, Pollard RB, Landay A, Aga E, Fox L, Mitsuyasu R. Continuing or adding IL-2 in patients treated with antiretroviral therapy (ACTG Protocol A5051, a rollover trial of ACTG Protocol A328). AIDS Res Ther. 2010 Aug 5;7:30. doi: 10.1186/1742-6405-7-30.
PMID: 20687947RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ronald Mitsuyasu
- STUDY CHAIR
Richard Pollard
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
August 1, 2004
Last Updated
May 21, 2012
Record last verified: 2012-05