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).
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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