Prevention of Maternal-to-Infant HIV Transmission/India

描述（由申请人提供）：本竞争性延续（2类）申请的目的是申请额外资金，以完成NIH在印度浦那发起的一项正在进行的III期临床试验，该试验题为“预防印度母婴艾滋病毒传播”，于2002年8月16日启动。本研究是一项在HIV感染母亲及其母乳喂养婴儿中进行的随机化、双臂、开放标签试验，旨在比较标准母亲/婴儿单次给药奈韦拉平（NVP）（第1组）与单次给药NVP方案加低剂量婴儿NVP每日给药产后6周（第2组）的安全性和疗效。这项试验的主要结果是比较婴儿在产后6个月的艾滋病毒感染率。这项研究还有次要目的，包括测量产后9个月时母亲对NVP的耐药性，以及测量参与母亲及其婴儿的死亡率和发病率。2002年8月16日至2004年7月31日期间，20 800多名同意的母亲接受了艾滋病毒检查，408名合格的母亲参加了临床试验。本临床试验的NIAID DSMB建议将印度试验的主要终点数据与埃塞俄比亚和乌干达类似试验中心的数据合并。所有三个研究中心的试验设计、研究干预、合格性标准、数据管理程序和研究程序的一致性促进了这一建议。这项新的合并分析的总样本量为1964，其中包括来自我们在印度试验中心的730名婴儿的数据。

DESCRIPTION (provided by applicant): The objective of this Competitive Continuation (Type 2) application is to request additional funding to complete an ongoing NIH-sponsored Phase III clinical trial in Pune, India entitled "Prevention of Mother-to-Infant HIV Transmission in India", which was initiated 16 August 2002. This study is a randomized, 2-arm, open-labeled trial among HIV-infected mothers and their breast-fed infants designed to compare the safety and efficacy of standard maternal/infant single dose nevirapine (NVP) (Arm 1) to the single dose NVP regimen plus low-dose daily infant NVP for 6 weeks post-partum (Arm 2). The primary outcome of this trial is the comparison of infant HIV infection rates at 6 months post-partum. This study also has secondary objectives, including the measurement of maternal NVP drug resistance at 9 months postpartum, as well as the measurement of mortality and morbidity rates among participating mothers and their infants. Between 16 August 2002 and 31 July 2004, more than 20,800 consenting mothers have been HIV screened and 408 eligible mothers have been enrolled in the clinical trial. The NIAID DSMB for this clinical trial recommended the merging of the primary endpoint data from this trial in India, with data from similar trial sites in Ethiopia and Uganda. This recommendation was facilitated by the consistency in trial designs, study interventions, eligibility criteria, data management procedures and study procedures for all three sites. The total sample size for this new merged analysis is 1964, which will include data from 730 nfants from our trial site in India.