Researching Alveolar Macrophage Improvements With Supplements in HIV

NCT02264860 | Completed DMC

• 2 other identifiers: IRB00062730a1R01HL125042-01
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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 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.

Conditions

HIV-1 Infection

Outcome Measures

Primary Outcomes (1)

• Dosage Efficacy

  Incidence of treatment-related adverse events, particularly gastrointestinal problems such as nausea, gastritis or diarrhea

  Three months

Secondary Outcomes (2)

• Change in exhaled breath condensate (EBC) levels of glutathione (GSH)

  Baseline, 12 months

• Change in exhaled breath condensate (EBC) levels of glutathione (GSH)

  Baseline, 24 months

Study Arms (1)

Nutritional Supplements Zinc and SAMe

OTHER

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

Interventions

Zinc and SAMe DIETARY_SUPPLEMENT

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.

Nutritional Supplements Zinc and SAMe

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Emory University: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Ponce De Leon Center

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Interventions

Zinc; S-Adenosylmethionine

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Methionine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• David M Guidot, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Pulmonary, Allergy, & Critical Care Medicine

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 15, 2014
• Study Start: October 1, 2014
• Primary Completion: December 15, 2018
• Study Completion: December 15, 2018
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

US (1)