Status:
COMPLETED
Researching Alveolar Macrophage Improvements With Supplements in HIV
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
HIV-1 Infection
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
This new proposal entitled "The alveolar macrophage pool is a reservoir of HIV" addresses a fundamental question; specifically, does the alveolar macrophage pool serve as a reservoir of HIV even when ...
Eligibility Criteria
Inclusion
- Subjects living with HIV-1 infection who have been on anti-retroviral therapy (ART) for a minimum of 18 months and are followed longitudinally for their HIV healthcare in one of the study sites in Atlanta.
- Ability to give informed consent.
Exclusion
- Documented history of cirrhosis or a direct bilirubin ≥ 2.0 mg/ld.
- Documentation of left ventricular ejection fraction \< 40% or myocardial infarction within the past 6 months.
- End-stage renal disease requiring dialysis or a serum creatinine ≥ 2 mg/dL.
- Spirometry with Forced vital capacity (FVC) or Forced expiratory volume in 1 second (FEV1) \< 70% of predicted value.
- Diabetes
- Known or possible pregnancy or attempting to become pregnant or breastfeeding
- BMI \< 17
- Age \< 21
- Parkinson's disease: these are all b/c the SAMe risks sections states that these pts will not qualify
- Bipolar disorder
- Bleeding disorders such as thrombocytopenia or significant gastrointestinal bleeding within the past year
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2018
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT02264860
Start Date
October 1 2014
End Date
December 15 2018
Last Update
May 1 2019
Active Locations (1)
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1
Ponce De Leon Center
Atlanta, Georgia, United States, 30308