Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033176
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2002-04-08
Brief Title:
Immune Restoration by Lipoic Acid in AIDS
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Immune Restoration by Lipoic Acid in AIDS
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 alternativecomplementary medicine CAM that can restore an immune system ravaged by HIVAIDS 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 HIVAIDS 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 HIVAIDS 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 ie those with persistent CD4 count 50 cellsmm3 viral load 10000 copiescc 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 24 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
In this study HIV-infected adults unresponsive to HAART ie those with persistent CD4 count 50 cellsmm3 viral load 10000 copiescc 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 24 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None