Clinical trial NCT00033176: Immune Restoration by Lipoic Acid in AIDS
Official title: Immune Restoration by Lipoic Acid in AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acquired Immunodeficiency Syndrome
HIV Infections
Keywords: complementary therapies
Immune restoration
HIV infection
AIDS
HAART non-responsiveness
glutathione restoration
lipoic acid
dithiol
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2002-04-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: San Jose
country: United States
facility: Eye Clinic, Santa Clara Valley Medical Center
state: California
Study officials:
affiliation: California Institute for Medical Research
name: Raxit J. Jariwalla, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Santa Clara Valley Medical Center
name: Abha Kumar, MD
affiliation: Quest Clinical Research
name: Jay Lalezari, MD
References: