Overview

Immune Restoration by Lipoic Acid in AIDS

Status:
Completed
Trial end date:
2004-08-01
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Treatments:
Thioctic Acid
Criteria
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.