Researching Alveolar Macrophage Improvements With Supplements in HIV

Completed · Not applicable

Conditions studied: HIV-1 Infection

In brief

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.

Key facts

Study ID

NCT02264860

Run by

Emory University

People needed

67

Starts

2014-10-01

Expected to finish

2018-12-15

Last updated by the study team

2019-05-01

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Ponce De Leon Center — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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