Immune Restoration by Lipoic Acid in AIDS
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| ClinicalTrials.gov Identifier: NCT00033176 |
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Recruitment Status :
Completed
First Posted : April 9, 2002
Last Update Posted : August 18, 2006
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acquired Immunodeficiency Syndrome HIV Infections | Drug: Alpha Lipoic Acid | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 33 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | Immune Restoration by Lipoic Acid in AIDS |
| Study Start Date : | February 2002 |
| Study Completion Date : | August 2004 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033176
| United States, California | |
| Quest Clinical Research | |
| San Francisco, California, United States, 94115 | |
| Eye Clinic, Santa Clara Valley Medical Center | |
| San Jose, California, United States, 95128 | |
| Principal Investigator: | Raxit J. Jariwalla, PhD | California Institute for Medical Research | |
| OverallOfficial: | Abha Kumar, MD | Santa Clara Valley Medical Center | |
| OverallOfficial: | Jay Lalezari, MD | Quest Clinical Research |
| ClinicalTrials.gov Identifier: | NCT00033176 History of Changes |
| Other Study ID Numbers: |
R21AT000246-01A2 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 9, 2002 Key Record Dates |
| Last Update Posted: | August 18, 2006 |
| Last Verified: | July 2006 |
Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
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complementary therapies Immune restoration HIV infection AIDS |
HAART non-responsiveness glutathione restoration lipoic acid dithiol |
Additional relevant MeSH terms:
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HIV Infections Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases Slow Virus Diseases |
Thioctic Acid Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Nutrients Growth Substances |