Immune Restoration by Lipoic Acid in AIDS

Completed · Phase 2

Conditions studied: Acquired Immunodeficiency Syndrome, HIV Infections

In brief

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).

Key facts

Study ID

NCT00033176

Run by

National Center for Complementary and Integrative Health (NCCIH)

People needed

33

Starts

2002-02-01

Expected to finish

2004-08-01

Last updated by the study team

2006-08-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Quest Clinical Research — San Francisco, California, United States
• Eye Clinic, Santa Clara Valley Medical Center — San Jose, California, United States

Full record on ClinicalTrials.gov

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