Immune Enhancement for Immunological Non-responders to ART
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Immune Enhancement for Immunological Non-responders to ART
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Known or possible pregnancy or attempting to become pregnant.
- •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
研究组 & 干预措施
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
干预措施: Zinc and SAMe (Dietary Supplement)
结局指标
主要结局
Immune Enhancement for Immunological Non-responders to ART
时间窗: 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'
次要结局
未报告次要终点
研究者
David M. Guidot, MD
Principal Investigator
Emory University