HIVIMMUNENCT01806870
Immune Enhancement for Immunological Non-responders to ART
A study testing Zinc and SAMe in people with HIV, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Zinc and SAMe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2013to 15 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grady Hospital- Ponce De Leon Clinic
Atlanta, Georgia, 30308
Atlanta VA Medical Center
Decatur, Georgia, 30033
About this study
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.
Read the 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
- Conditions
- HIV
- Being tested
- Zinc and SAMe
- Keywords
- HIV, ART
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc and SAMeDietary supplement
If a subject has side effects their dose of Zinc will be reduced. SAMe will remain the same dose.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Zinc and SAMe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'
Measured: First 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startMar 2013
- Primary completion15 Dec 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, David M. Guidot, MD, Emory University
- Investigators
- David Guidot, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806870
- Sponsor's protocol ID
- IRB00062730
- Other IDs
- 1R34HL117351-01
- Acronym
- IMMUNE
- Status last verified
- Jul 2019
- First submitted
- 6 Mar 2013
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Enhancement for Immunological Non-responders to ART
- ClinicalTrials.gov ID
- NCT01806870
- Acronym / sponsor ID
- IMMUNE / IRB00062730
- Conditions
- HIV
- Keywords
- HIV, ART
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2013 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 7 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutritional Supplements Zinc and SAMe | Experimental | Dietary Supplement: Zinc and SAMeEach subject will receive 1600mg of SAMe per day Men subjects will receive 30mg Zinc Women subjects will receive 25mg Zinc |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Subjects living with HIV-1 infection who have been on anti-retroviral therapy (ART) for a minimum of 18 months and:
- 2. Ability to give informed consent.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc and SAMeIf a subject has side effects their dose of Zinc will be reduced. SAMe will remain the same dose. | Dietary supplement | Nutritional Supplements Zinc and SAMe |
Primary outcome
Immune Enhancement for Immunological Non-responders to ART
Time frame: First 6 months
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'
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Guidot, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc and SAMe in people with HIV, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune Enhancement for Immunological Non-responders to ART (time frame: First 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.