Immune Enhancement for Immunological Non-responders to ART

Completed · Not applicable

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT01806870

Run by

Emory University

People needed

30

Starts

2013-03-01

Expected to finish

2018-12-15

Last updated by the study team

2019-07-18

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Grady Hospital- Ponce De Leon Clinic — Atlanta, Georgia, United States
• Atlanta VA Medical Center — Decatur, Georgia, United States

Full record on ClinicalTrials.gov

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