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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David M. Guidot, MD, Emory University
ClinicalTrials.gov Identifier:
NCT01806870
First received: March 6, 2013
Last updated: December 3, 2013
Last verified: December 2013
  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
No Intervention: Nutritional Supplements
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.

  Hide Detailed Description

Detailed Description:

There will be up to eleven study visits and three telephone visits. All study procedures are for research purposes. All study subjects will receive the nutritional supplements zinc and SAMe.

During the study you will be asked to answer questions about your alcohol use and smoking history. You will have exhaled breath tests, blood draws, physical exams, and bronchoscopies. Your medical records will be reviewed during the study. If you are a woman of childbearing age, a urine pregnancy test will be done at each study visit.

Visit 1 (screening visit): This visit will last about 2 hours. At this visit you will:

  • Have a physical exam
  • Review your medical history
  • Review your medications
  • Have blood drawn
  • Have a urine pregnancy test for women of child-bearing age
  • Complete a survey about your alcohol use and smoking history.
  • Discuss and schedule a bronchoscopy for the next visit You may not be eligible to continue in the study if the blood work done at visit one is not within normal limits or if you are pregnant. A study team member will contact you to let you know if you do or do not qualify to participate in the remainder of the study.

Visit 2: This visit will last about 6 hours and will take place at the Hospital. At this visit you will:

  • Have a physical exam
  • Have blood drawn
  • Have a urine pregnancy test for women of child-bearing age
  • Do an exhaled breath test
  • Have a bronchoscopy
  • Receive nutritional supplements and education

Treatment: The nutritional supplements zinc and SAMe will be given to you by the study team at visit 2. You will be asked to take the tablets once a day.

If you experience upset stomach, abdominal cramps, diarrhea, or other uncomfortable side effects, we will reduce the amount of the nutritional supplements. If you are unable to tolerate the nutritional supplements, you will be withdrawn from the research study.

Visits 3, 4, and 5 -Telephone Contact: You will receive a telephone call at one, two, and three weeks after visit 2 to ask you how you are tolerating the study supplements. If you are experiencing side effects such as upset stomach, abdominal cramps, or diarrhea, we will instruct you to decrease the dose of the supplements.

Visits 6, 7, and 8 (months one, two, and three): These visits will last about 30 minutes and will be scheduled two months apart. At this visit you will:

  • Have blood drawn
  • Have a urine pregnancy test for women of child-bearing age
  • Do an exhaled breath test
  • Answer questions about how you are tolerating the nutritional supplements
  • Receive nutritional supplements and education

If your exhaled breath test is at goal at visit 6, you will continue to take the dietary supplements for one year from this point forward. If your exhaled breath test is not at goal at visit 6, you will be asked to return for visit 7. If your exhaled breath test is at goal at visit 7, you will continue to take the dietary supplements for one year from this point forward. If your exhaled breath test is not at goal at visit 7, you will be asked to return for visit 8. You will be asked to take the nutritional supplements for one year from this point forward.

Visits 9 through 13: These visits will last about 30 minutes and will be scheduled two months apart.

At this visit you will:

  • Have blood drawn
  • Have a urine pregnancy test for women of child-bearing age
  • Answer questions about how you are tolerating the nutritional supplements
  • Receive nutritional supplements and education

Visit 14: This is the final study visit. It will last about 6 hours and will take place at the Hospital. At this visit you will:

  • Have a physical exam
  • Have blood drawn
  • Have a urine pregnancy test for women of child-bearing age
  • Do an exhaled breath test
  • Have a bronchoscopy procedure
  • Return unused nutritional supplements
  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 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 FVC or 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: December 3, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Emory University:
HIV
ART

Additional relevant MeSH terms:
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014