Researching Alveolar Macrophage Improvements With Supplements in HIV (RAISe)
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|ClinicalTrials.gov Identifier: NCT02264860|
Recruitment Status : Recruiting
First Posted : October 15, 2014
Last Update Posted : February 1, 2018
HIV infection causes systemic zinc deficiency and oxidative stress that impairs host immunity in the alveolar space.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.
The investigators hypothesize that long-term dietary supplementation with zinc and the glutathione precursor SAMe will enhance pulmonary host immune function in HIV-infected individuals who do not respond adequately to ART alone.
|Condition or disease||Intervention/treatment||Phase|
|HIV-1 Infection||Dietary Supplement: Zinc and SAMe||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cohort 2: Researching Alveolar Macrophage Improvements With Supplements in HIV|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Nutritional Supplements Zinc and SAMe
All men subjects will be started on 30 mg/day and women will be started on 25mg of elemental zinc plus 1600 mg/day of SAMe.
Dietary Supplement: Zinc and SAMe
The subjects will have the supplements dispensed at visit 2. They will be contacted weekly for the next three weeks to ensure that they are tolerating the supplements without significant side-effects. If these side-effects are significant then the dose of zinc will be decreased for all subjects to 15 mg of elemental zinc/day; if symptoms persist the SAMe dose will then be decreased by 25% (to 1200 mg/day) and then by 50% (to 800 mg/day) if necessary until the supplements are tolerated. 12 mg of zinc and 800 mg of SAMe is the lowest dose possible.
- Dosage Efficacy [ Time Frame: Three months ]Incidence of treatment-related adverse events, particularly gastrointestinal problems such as nausea, gastritis or diarrhea
- Change in exhaled breath condensate (EBC) levels of glutathione (GSH) [ Time Frame: Baseline, 12 months ]Collection of exhaled breath condensate (EBC) is a non-invasive technique obtained by freezing and collecting exhaled breath that contains glutathione (GSH) from the lower airways. EBC GSH is measured is nmoles/µg urea.
- Change in exhaled breath condensate (EBC) levels of glutathione (GSH) [ Time Frame: Baseline, 24 months ]Collection of exhaled breath condensate (EBC) is a non-invasive technique obtained by freezing and collecting exhaled breath that contains glutathione (GSH) from the lower airways. EBC GSH is measured is nmoles/µg urea.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02264860
|Contact: David M Guidot, MDfirstname.lastname@example.org|
|Contact: Elena Morales, BS||404-321-6111 ext email@example.com|
|United States, Georgia|
|Ponce De Leon Center||Recruiting|
|Atlanta, Georgia, United States, 30308|
|Contact: Vincent Marconi, MD 404-616-0673 firstname.lastname@example.org|
|Principal Investigator: David M Guidot, MD|
|Principal Investigator:||David M Guidot, MD||Emory University|