Immune Enhancement for Immunological Non-responders to ART (IMMUNE)
The purpose of this study is to see if taking two nutritional supplements, zinc and SAMe (S-adenosylmethionine), can improve lung health and immune function in persons with HIV. You are being asked to volunteer because you have HIV (Human Immunodeficiency Virus) and you take anti-retroviral therapy (ART) medications.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Immune Enhancement for Immunological Non-responders to ART|
- Immune Enhancement for Immunological Non-responders to ART [ Time Frame: First 6 months ] [ Designated as safety issue: No ]Optimize the dosing of dietary zinc and SAMe that restores redox balance and zinc bioavailability in the airways of a cohort of HIV-infected individuals who are 'immunological non-responders'
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
No Intervention: Nutritional Supplements
Each subject will receive 1600mg of SAMe per day Men subjects will receive 30mg Zinc Women subjects will receive 25mg Zinc
Dietary Supplement: Zinc and SAMe
If a subject has side effects their dose of Zinc will be reduced. SAMe will remain the same dose.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01806870
|United States, Georgia|
|Grady Hospital- Ponce De Leon Clinic|
|Atlanta, Georgia, United States, 30308|
|Atlanta VA Medical Center|
|Decatur, Georgia, United States, 30033|
|Principal Investigator:||David Guidot, MD||Emory University|