Treatment With Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328
NCT00000923 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2012-05-21
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.
Conditions
- HIV Infections
Interventions
- DRUG
-
Indinavir sulfate
- DRUG
-
Lamivudine
- DRUG
-
Stavudine
- DRUG
-
Zidovudine
- DRUG
-
Didanosine
- DRUG
-
Aldesleukin
Sponsors & Collaborators
-
National Institute of Allergy and Infectious Diseases (NIAID)
lead NIH
Principal Investigators
-
Ronald Mitsuyasu
-
Richard Pollard
Study Design
- Purpose
- TREATMENT
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Completion
- 2004-08-31
Countries
- United States
Study Locations
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