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Immune restoration by lipoic acid in AIDS Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Immune restoration by lipoic acid in AIDS conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Immune restoration by lipoic acid in AIDS Clinical research trials and Immune restoration by lipoic acid in AIDS medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Immune restoration by lipoic acid in AIDS. Immune restoration by lipoic acid in AIDS Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Immune restoration by lipoic acid in AIDS clinical trial. Participants oftentimes recieve the finest healthcare available for their Immune restoration by lipoic acid in AIDS condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Immune restoration by lipoic acid in AIDS  Immune restoration by lipoic acid in AIDS
Immune restoration by lipoic acid in AIDS
For Condition: Acquired Immunodeficiency Syndrome,HIV Infections
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: 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).
Details: 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 amended placebo-controlled study, 42 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 two arms, treatment and control, of 21 patients each. 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, bimonthly and at 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 unpaired 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 106 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.
Total Enrollment: 42
Location and Contact Information:
Overall Study Official:
SamMansour, , Santa Clara Valley Medical Center
Eye Clinic, Santa Clara Valley Medical Center *Recruiting*
San Jose, California, 95128
United States
Recruiting
Additional Information:
Study ID Numbers: 1 R21 AT00246-01A2;
Study Start Date: February 2002
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033176
Other Acquired Immunodeficiency Syndrome Studies:
1. Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients
2. A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients
3. Effect of a Change in HIV Therapy on Liver Steatosis, Inflammation, and Fibrosis
4. Safety and Effectiveness of a Combination Anti-HIV Drug Treatment
5. A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
Related Studies:
Other Acquired Immunodeficiency Syndrome Clinical Trials
Other California Clinical Trials
Other San Jose Clinical Trials
Immune restoration by lipoic acid in AIDS
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