Immune Enhancement for Immunological Non-responders to ART (IMMUNE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David M. Guidot, MD, Emory University
ClinicalTrials.gov Identifier:
NCT01806870
First received: March 6, 2013
Last updated: October 17, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
HIV
Dietary Supplement: Zinc and SAMe

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Immune Enhancement for Immunological Non-responders to ART

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Immune Enhancement for Immunological Non-responders to ART [ Time Frame: First 6 months ] [ Designated as safety issue: No ]
    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'


Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nutritional Supplements Zinc and SAMe
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
If a subject has side effects their dose of Zinc will be reduced. SAMe will remain the same dose.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  1. Documented history of cirrhosis or a total bilirubin ≥ 2.0 mg/dL.
  2. Documentation of left ventricular ejection fraction < 40% or myocardial infarction within the past 6 months.
  3. End-stage renal disease requiring dialysis or a serum creatinine ≥ 2 mg/dL.
  4. Spirometry with Forced vital capacity (FVC) or Forced expiratory volume in 1 second (FEV1) < 70% of predicted value.
  5. Diabetes
  6. Known or possible pregnancy or attempting to become pregnant.
  7. BMI < 17
  8. Age < 21
  9. Parkinson's disease: these are all b/c the SAMe risks sections states that these pts will not qualify
  10. Bipolar disorder
  11. Bleeding disorders such as thrombocytopenia or significant gastrointestinal bleeding within the past year
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01806870

Locations
United States, Georgia
Grady Hospital- Ponce De Leon Clinic
Atlanta, Georgia, United States, 30308
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: David Guidot, MD Emory University
  More Information

No publications provided

Responsible Party: David M. Guidot, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01806870     History of Changes
Other Study ID Numbers: IRB00062730, 1R34HL117351-01
Study First Received: March 6, 2013
Last Updated: October 17, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Emory University:
HIV
ART

ClinicalTrials.gov processed this record on October 19, 2014