Nevirapine Plus Zidovudine to Prevent Perinatal HIV in Thailand
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,792
- 试验地点
- 1
- 主要终点
- Definitive HIV infection in infants as assessed by positive HIV DNA PCR on two peripheral blood samples
研究概览
简要总结
The purpose of this study was to assess the efficacy of a single dose of the drug nevirapine (NVP) given to pregnant women at onset of labor and to their infant 48-72 hours after birth in addition to standard oral zidovudine (ZDV or AZT) prophylaxis for the prevention of mother-to-child transmission of HIV-1.
详细描述
Multicenter, randomized, three arms, double-blind, controlled study. Study population was HIV-infected pregnant women who were on ZDV prophylaxis for more than two weeks and gave informed consent. If eligible, women completed a baseline check-up. Women meeting selection criteria were randomly assigned to receive one of three study regimens, in addition to ZDV prophylaxis:
- One dose maternal NVP treatment at onset of labor, and one dose of infant NVP treatment 48-72 hours after birth
- One dose maternal NVP treatment at onset of labor, and one dose of infant placebo 48-72 hours after birth
- One dose maternal placebo at onset of labor, and one dose of infant placebo 48-72 hours after birth. This was the reference study arm.
Follow-up of women and infants was carried out on an outpatient basis except for delivery and the first three days after delivery.
AMENDMENT
After the first interim analysis, enrollment in Placebo-Placebo arm was terminated on May 2, 2002, according to the recommendation of the Data and Safety Monitoring Board. The target sample size was increased to 660, instead of 510, in each of the two remaining arms (N-N and N-P) to ensure enough power to test for non-inferiority between these arms with a limit of 2.5%.
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
- Double
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •evidence of pre-existing fetal anomalies incompatible with life;
- •known hypersensitivity to any benzodiazepine or to NVP;
- •receipt of antiretroviral agent other than ZDV;
- •receipt of non-allowed concomitant treatment;
- •uncontrolled hypertension;
- •concurrent participation in another clinical trial;
- •women with a CD4 count <200/µL or history of oral candidiasis if they were not receiving PCP prophylaxis.
研究组 & 干预措施
1
One dose maternal NVP treatment at onset of labor, and one dose of infant NVP treatment 48-72 hours after birth (NVP-NVP)
干预措施: Single dose nevirapine to the mother and to the child (Drug)
2
One dose maternal NVP treatment at onset of labor, and one dose of infant placebo 48-72 hours after birth. (NVP-Placebo)
干预措施: Single dose nevirapine to the mother and placebo to the child (Drug)
3
One dose maternal placebo at onset of labor, and one dose of infant placebo 48-72 hours after birth. This was the reference study arm. (Placebo-Placebo)
干预措施: Single dose placebo to the mother and to the child (Drug)
结局指标
主要结局
Definitive HIV infection in infants as assessed by positive HIV DNA PCR on two peripheral blood samples
次要结局
- Tolerance of nevirapine, in particular rashes.