Continuing or adding IL-2 in patients treated with antiretroviral therapy (ACTG Protocol A5051, a rollover trial of ACTG Protocol A328).
Ronald J Bosch, Richard B Pollard, Alan Landay...
https://pubmed.ncbi.nlm.nih.gov/20687947Completed
Phase Not Applicable
Age: 18Years +
All Genders
ID00000923
Treatment Rollover for Subjects Formerly on ACTG 328 With Subcutaneous Interleukin-2 (IL-2) in Combination With Highly Active Antiretroviral Therapy (HAART)
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2012-05-21
110
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment With Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
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.)
Exclusion Criteria
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 12 locations
1
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35294
Status Unknown
2
USC CRS
Los Angeles, California, United States, 900331079
Status Unknown
3
Harbor-UCLA Med. Ctr. CRS
Torrance, California, United States, 90502
Status Unknown
4
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States, 96816
Status Unknown
5
Univ. of Iowa Healthcare, Div. of Infectious Diseases
Iowa City, Iowa, United States, 52242
Status Unknown
6
Tulane Univ. A1701 CRS
New Orleans, Louisiana, United States, 70112
Status Unknown
7
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States, 63112
Status Unknown
8
Washington U CRS
St Louis, Missouri, United States
Status Unknown
9
Mt. Sinai Med. Ctr. A0404 CRS
New York, New York, United States, 10029
Status Unknown
10
Case CRS
Cleveland, Ohio, United States, 44106
Status Unknown
11
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States, 432101228
Status Unknown
12
University of Washington AIDS CRS
Seattle, Washington, United States, 98104
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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