HIV Disease, Drug Abuse, and Nutrient Therapy in Botswana
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 878
- 试验地点
- 1
- 主要终点
- HIV Disease Progression
研究概览
简要总结
The purpose of this trial is to determine whether supplementation with multivitamins and selenium will delay disease progression in HIV infected individuals in Botswana. The study will also assess how drug abuse modifies the effect of nutritional supplementation on HIV disease progression.
详细描述
Botswana has the highest rates of HIV infection in the world. In addition, drug abuse has become an emerging problem in Botswana. Past research suggests that multivitamin and selenium supplementation slows the progression of HIV disease. The purpose of this trial is to evaluate the effectiveness of supplementation with multivitamins and selenium in HIV infected individuals in Botswana.
This trial will last 2 years. Participants will be randomly assigned to 4 groups: a combination of multivitamins with selenium, multivitamins alone, selenium alone, or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV infected
- •CD4 count greater than 350 cells/mm3
- •Identified from the Infectious Disease Care Clinic
- •Body mass index greater than 18 for women and greater than 18.5 for men
排除标准
- •Current AIDS-defining condition
- •Currently participating in another clinical trial
- •Pregnant or intends to become pregnant during the study
结局指标
主要结局
HIV Disease Progression
时间窗: For at least 6 months
次要结局
- Morbidity(For at least 6 months)