Routine Use of Antiretroviral Therapy to Prevent Mother-to-Child HIV Transmission in the Kafue District of Zambia (Impact of HAART to Prevent Pediatric AIDS in Rural Zambia).
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- HIV Infection
研究概览
简要总结
The investigators will enroll a cohort of HIV-infected pregnant women accessing PMTCT services, to better understand the incremental benefits (e.g. reduction in HIV transmission, improvements in HIV-free survival) and risks (e.g. drug toxicities) of the routine HAART strategy, in comparison to HIV-infected pregnant women accessing the Zambian Standard of Care services.
The investigators will test the hypothesis that routine use of HAART produces significant reductions in HIV transmission rates, with only minimal side effects.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HIV infected
- •Pregnant women
- •Ability to provide informed consent.
- •Meets eligibility criteria for HAART initiation
排除标准
- •Unwillingness to provide informed consent
- •Below the age of legal consent
研究组 & 干预措施
Routine three-drug antiretroviral prophyalxis
Cohort of 160 HIV-infected women, approached at > 28 weeks gestation and initiated on routine HAART for the purposes of PMTCT.
干预措施: Routine three-drug antiretroviral prophylaxis (Drug)
结局指标
主要结局
HIV Infection
时间窗: 12 months
次要结局
- HIV Infection(6 weeks, 6 months and 24 months)
- Infant survival(12 and 24 months)
- HIV-free survival(12 months and 24 months)
- Incidence of maternal toxicity to HAART regimens(24 months)
研究者
Benjamin Chi, MD, MSc
Associate Professor
University of North Carolina, Chapel Hill