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Immune Restoration by Lipoic Acid in AIDS

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00033176
First received: April 8, 2002
Last updated: August 17, 2006
Last verified: July 2006

April 8, 2002
August 17, 2006
February 2002
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Complete list of historical versions of study NCT00033176 on ClinicalTrials.gov Archive Site
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Immune Restoration by Lipoic Acid in AIDS
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).

AIDS is characterized by infection with HIV which leads to collapse of the immune system. Although highly active antiretroviral therapy (HAART) has contributed significantly to lowering morbidity and mortality from AIDS, antiretroviral drugs do not fully restore the immune system and patients often fail multi-drug treatment. Hence, there is a need for alternative/complementary medicine (CAM) that can restore an immune system ravaged by HIV/AIDS. To address this need, investigators have formed a multidisciplinary collaboration to evaluate and demonstrate utility of natural immune-based modulators in ethnically diverse patients with HIV/AIDS. The long-term goal of this proposal is to develop a CAM therapy to facilitate immune reconstitution and HIV eradication following cessation of antiretroviral treatment or concurrent with continued antiretroviral treatment. It is based on the premise of a widespread deficiency of glutathione (GSH), vital to lymphocyte function, in patients with HIV/AIDS. The proposed project will study the immunomodulatory and antiretroviral effects of a dietary antioxidant, alpha-lipoic acid (ALA), which is known to efficiently boost systemic GSH.

In this study, HIV-infected adults unresponsive to HAART (i.e. those with persistent CD4+ count > 50 cells/mm3, viral load> 10,000 copies/cc) will be randomized into a treatment or a control arm. The treatment group will be given 300 mg ALA thrice daily for 6 months and the control group will receive inert placebo. Studies performed at baseline and at 2,4, and 6 months will include estimation of CD4+ count, HIV RNA, T-cell reactivity in vitro and whole blood GSH level. Significance of changes from baseline parameters will be analyzed by t-tests. The proposed research will show whether GSH augmentation by ALA increases CD4+ cell number and T cell function and reduces viral load in subjects unresponsive to antiretroviral therapy.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
Drug: Alpha Lipoic Acid
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
August 2004
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00033176
R21 AT000246-01A2
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National Center for Complementary and Alternative Medicine (NCCAM)
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Principal Investigator: Raxit J. Jariwalla, PhD California Institute for Medical Research
Investigator: Abha Kumar, MD Santa Clara Valley Medical Center
Investigator: Jay Lalezari, MD Quest Clinical Research
National Center for Complementary and Alternative Medicine (NCCAM)
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP