HIV Infections Clinical Trial
Official title:
Immune Restoration by Lipoic Acid in AIDS
The purpose of this study is to determine the immunomodulatory and antiviral effects of the glutathione-restoring dithiol, alpha lipoic acid (ALA) in HIV-infected persons unresponsive to highly active antiretroviral treatment (HAART).
Status | Completed |
Enrollment | 33 |
Est. completion date | August 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - HIV-positive status - HAART non-responsiveness as defined by 1) previous experience with at least 2 different protease inhibitors plus nucleoside analogs; 2) viral load of >10,000 copies/cc and CD4+ cell count >50 x 1000 cells/liter at time of enrollment Exclusion Criteria: - Diabetic patients - Pregnant women - Asthmatic patients - Severely thiamine-deficient persons (e.g. alcoholics and those with polyneuritis) - History of supplementing on excessive amounts of N-acetylcysteine, glutathione or other antioxidant supplements, during the 2 months prior to study entry. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Quest Clinical Research | San Francisco | California |
United States | Eye Clinic, Santa Clara Valley Medical Center | San Jose | California |
Lead Sponsor | Collaborator |
---|---|
National Center for Complementary and Integrative Health (NCCIH) |
United States,
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