Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 915
- 试验地点
- 1
- 主要终点
- Change in CD4 cell counts and viral load from baseline to six weeks and six months postpartum in HIV-1 positive women
研究概览
简要总结
The purpose of this study is to determine whether the oral administration of daily selenium supplements to HIV-1 positive pregnant women: enhances immune status and reduces the HIV-1 viral load at six months postpartum, reduces the risk of lower genital shedding of HIV-1 infected cells at 36 weeks of gestation, and reduces the risk of mastitis at six weeks postpartum, compared to placebo.
详细描述
We are recruiting pregnant women who are infected with HIV and assign them to receive selenium or placebo. All women will be given standard prenatal care, including nevirapine for the prevention of mother-to-child transmission and prenatal multivitamin supplements. We will examine the effect of the selenium supplements on intermediate outcomes predictive of the risks of transmission of HIV and to disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HIV-1 Infected women between 12 and 27 weeks of gestation
排除标准
- •Women with clinical AIDS defined according to WHO Criteria
结局指标
主要结局
Change in CD4 cell counts and viral load from baseline to six weeks and six months postpartum in HIV-1 positive women
时间窗: Enrollment (12-27 wks gestation) to 6 months postpartum
Risk of lower genital shedding of HIV-1 infected cells at 36 wks gestation
时间窗: At 36 wks gestation
次要结局
- Risk of subclinical mastitis as defined by elevated sodium concentrations in breastmilk at 6 weeks postpartum(6 weeks postpartum)
- Fetal death, premature delivery, and low birth weight(Delivery)