Immune Restoration by Lipoic Acid in AIDS
Immune Restoration by Lipoic Acid in AIDS
Sponsors
Source
National Center for Complementary and Integrative Health (NCCIH)
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.
Overall Status
Completed
Start Date
2002-02-01
Completion Date
2004-08-01
Primary Completion Date
N/A
Phase
Phase 2
Study Type
Interventional
Enrollment
33
Conditions
Intervention
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.
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Raxit J. Jariwalla, PhD |
Principal Investigator |
California Institute for Medical Research |
|
Abha Kumar, MD |
Santa Clara Valley Medical Center | |
|
Jay Lalezari, MD |
Quest Clinical Research |
Location
Facility |
|
Quest Clinical Research San Francisco California 94115 United States |
|
Eye Clinic, Santa Clara Valley Medical Center San Jose California 95128 United States |
Location Countries
Country
United States
Verification Date
2006-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Keywords
Has Expanded Access
No
Condition Browse
Intervention Browse
Mesh Term
Thioctic Acid
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
Double
Study First Submitted
April 8, 2002
Study First Submitted Qc
April 8, 2002
Study First Posted
April 9, 2002
Last Update Submitted
August 17, 2006
Last Update Submitted Qc
August 17, 2006
Last Update Posted
August 18, 2006
ClinicalTrials.gov processed this data on December 12, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.