Immune Enhancement for Immunological Non-responders to ART

NCT01806870 | Completed DMC

• 2 other identifiers: IRB000627301R34HL117351-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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 volunteer because you have HIV (Human Immunodeficiency Virus) and you take anti-retroviral therapy (ART) medications.

Conditions

HIV

Keywords

HIV; ART

Outcome Measures

Primary Outcomes (1)

• Immune Enhancement for Immunological Non-responders to ART

  Optimize the dosing of dietary zinc and SAMe that restores redox balance and zinc bioavailability in the airways of a cohort of HIV-infected individuals who are 'immunological non-responders'

  First 6 months

Study Arms (1)

Nutritional Supplements Zinc and SAMe

EXPERIMENTAL

Each subject will receive 1600mg of SAMe per day Men subjects will receive 30mg Zinc Women subjects will receive 25mg Zinc

Dietary Supplement: Zinc and SAMe

Interventions

Zinc and SAMe DIETARY_SUPPLEMENT

If a subject has side effects their dose of Zinc will be reduced. SAMe will remain the same dose.

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 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.
• \. 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

Sponsors & Collaborators

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

Study Sites (2)

Grady Hospital- Ponce De Leon Clinic

Atlanta, Georgia, 30308, United States

Location

Atlanta VA Medical Center

Decatur, Georgia, 30033, 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 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: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 7, 2013
• Study Start: March 1, 2013
• Primary Completion: December 15, 2018
• Study Completion: December 15, 2018
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

US (2)