Status:
COMPLETED
Immune Enhancement for Immunological Non-responders to ART
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
HIV
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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...
Detailed Description
There will be up to eleven study visits and three telephone visits. All study procedures are for research purposes. All study subjects will receive the nutritional supplements zinc and SAMe. During t...
Eligibility Criteria
Inclusion
- 1\. 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 or Seattle
- meet criteria for immunological non-responsiveness as defined by adherence to ART and cluster of differentiation 4 (CD4) count \<350 despite adequate retroviral suppression.
- 2\. Ability to give informed consent.
Exclusion
- Documented history of cirrhosis or a total bilirubin ≥ 2.0 mg/dL.
- 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.
- 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 :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01806870
Start Date
March 1 2013
End Date
December 15 2018
Last Update
July 18 2019
Active Locations (2)
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1
Grady Hospital- Ponce De Leon Clinic
Atlanta, Georgia, United States, 30308
2
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033