Immune Restoration by Lipoic Acid in AIDS

Immune Restoration by Lipoic Acid in AIDS

Patrocinadores

Patrocinador principal: National Center for Complementary and Integrative Health (NCCIH)

Fuente National Center for Complementary and Integrative Health (NCCIH)
Resumen breve

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).

Descripción detallada

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.

Estado general Completed
Fecha de inicio February 2002
Fecha de Terminación August 2004
Fase Phase 2
Tipo de estudio Interventional
Inscripción 33
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Alpha Lipoic Acid

Elegibilidad

Criterios:

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.

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Ubicación
Instalaciones:
Quest Clinical Research | San Francisco, California, 94115, United States
Eye Clinic, Santa Clara Valley Medical Center | San Jose, California, 95128, United States
Ubicacion Paises

United States

Fecha de verificación

July 2006

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Single Group Assignment

Propósito primario: Treatment

Enmascaramiento: Double

Fuente: ClinicalTrials.gov