Immune Enhancement for Immunological Non-responders to ART
| Status: | Active, not recruiting |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 7/27/2018 |
| Start Date: | March 2013 |
| End Date: | June 2019 |
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.
(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.
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
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
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
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