Zinc Therapy in Zinc Deficient HIV Positive Drug Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 231
- 试验地点
- 2
- 主要终点
- Immune failure
研究概览
简要总结
Zinc deficiency is prevalent in HIV infected individuals who abuse drugs. The purpose of this study is to determine if zinc therapy will prevent immune failure in HIV infected individuals who abuse drugs and have low plasma zinc levels.
详细描述
Low levels of zinc are associated with an increased risk of HIV-related death and opportunistic infections in HIV infected individuals. Drug users are especially susceptible to zinc deficiency. The purpose of this trial is to evaluate the effectiveness of zinc therapy in preventing immune failure in HIV infected individuals who abuse drugs.
This trial will last 30 months. Participants will be randomly assigned to receive either zinc supplements or placebo. Male participants will receive 15 mg of zinc and female participants will receive 12 mg of zinc. Clinical and laboratory study visits will occur at 3 or 6 month intervals throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV infected
- •Drug User
- •Blood zinc level greater than 0.35 mcg/mL and less than 0.75mcg/ml
排除标准
- •Currently participating in an another clinical trial
- •Blood selenium level less than 85 mcg/L
- •Pregnant or intends to become pregnant
结局指标
主要结局
Immune failure
时间窗: For at least 6 months
CD4 cell count \<200 cells/uL
次要结局
- Morbidity(For at least 6 months)
研究者
Marianna Baum
Professor
Florida International University