Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,300
- 试验地点
- 1
- 主要终点
- A. Rate of HIV infection at 9 months and assess HIV infection rates at 6-8 & 14 weeks, and 6, 12, 18, and 24 months. B.Determine HIV survival rates at ages 6, 12, 18, and 24 months. C. Evaluate safety of oral NVP and ZDV for 14 weeks.
研究概览
简要总结
The purpose of this study is to determine if extended antiretroviral regimens given to the infant during the first 14 weeks of age would decrease breast milk transmission of HIV.
详细描述
This is a three-arm randomized, open label, clinical trial to evaluate the effectiveness of two extended regimens of antiretrovirals compared to infant single dose nevirapine plus AZT given twice daily for 1 week (comparison regimen). All infants receive the comparison regimen at birth and then randomized at birth to start either one of the two extended regimens after the first week. The extended regimens are nevirapine daily and nevirapine plus AZT daily - both regimens are given up to age 14 weeks.
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
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Had given birth within the last 24 hours
- •Ability and willingness to give informed consent for HIV testing and enrollment into the study
- •Willing to receive HIV results
- •HIV infected
- •Planning to deliver or had given birth at the study clinics
- •Willing to come back for follow-up visits for 2 years postnatally
- •Resident of Blantyre city or its suburbs
排除标准
- •HIV negative
- •Women with discordant HIV results
- •Women who indicate that they will not breastfeed at time of delivery
- •Inability or unwillingness to follow any of the inclusion requirements
- •Newborn with life-threatening condition
- •Women who previously enrolled in this study and have a second pregnancy cannot reenroll
研究组 & 干预措施
A
Single dose NVP + ZDV daily for the first week.
干预措施: Nevirapine (Drug)
A
Single dose NVP + ZDV daily for the first week.
干预措施: AZT (Drug)
A
Single dose NVP + ZDV daily for the first week.
干预措施: NVP and AZT (Drug)
C
Arm A plus NVP + ZDV daily to age 14 weeks.
干预措施: Nevirapine (Drug)
C
Arm A plus NVP + ZDV daily to age 14 weeks.
干预措施: AZT (Drug)
C
Arm A plus NVP + ZDV daily to age 14 weeks.
干预措施: NVP+AZT (Drug)
B
Arm A plus oral NVP daily to age 14 weeks.
干预措施: Nevirapine (Drug)
B
Arm A plus oral NVP daily to age 14 weeks.
干预措施: NVP (Drug)
结局指标
主要结局
A. Rate of HIV infection at 9 months and assess HIV infection rates at 6-8 & 14 weeks, and 6, 12, 18, and 24 months. B.Determine HIV survival rates at ages 6, 12, 18, and 24 months. C. Evaluate safety of oral NVP and ZDV for 14 weeks.
时间窗: 9 months
次要结局
- To determine overall infant survival rates at 6, 12, 18 and 24 months.(6,12,18 & 24 months)