临床试验/NCT00197587

NCT00197587已完成不适用

Prevention of Milk-Borne Transmission of HIV-1C in Botswana ("Mashi")

Harvard School of Public Health (HSPH)0 个研究点目标入组 1,200 人开始时间: 2002年8月最近更新: 2013年5月20日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 1,200
主要终点: HIV PCR

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to find the most effective and safe treatment to prevent the passage of HIV from an infected mother to her baby.

详细描述

To assess the effectiveness of the addition of a single dose of nevirapine (NVP) to Zidovudine (ZDV, also known as AZT) as used in the Botswana mother-to-child transmission (MTCT) National Program, in reducing transmission of HIV-1 from mother to child. To determine if maternal NVP (per HIVNET 012 protocol) is necessary in the setting of maternal ZDV from 34 weeks gestation through delivery AND single-dose prophylactic infant NVP at birth plus ZDV from birth to 4 weeks for the reduction of transmission of HIV-1 from mother to child.
To assess the effect of prophylactic AZT given to infants during breast feeding on HIV transmission.
To confirm the safety and tolerance of one dose of NVP given to mothers and infants
To evaluate the safety and tolerance of AZT given to infants for up to 6 months of age
To determine the association between assigned infant feeding strategy and maternal morbidity and mortality
To determine the rates of virologic response to NNRTI-containing HAART at 26 and 52 weeks after initiating treatment, among HIV+ women who previously received single dose NVP versus placebo during labour.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Factorial
主要目的: Prevention
盲法: None

入排标准

年龄范围: 15 Years 至 45 Years（Child, Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Mothers must be no more than 34 weeks pregnant, intending to carry to term, intending to stay in area for at least 7 months, and consenting to HIV-1 testing and participation; HIV-1 infected by ELISA confirmed by Western blot; etc.

排除标准

未提供

研究组 & 干预措施

maternal nevirapine

Active Comparator

干预措施: Nevirapine (Drug)

maternal placebo

Placebo Comparator

干预措施: No intervention (Drug)

结局指标

主要结局

HIV PCR

时间窗: 1 month

The primary endpoint was infant HIV infection by the 1-month visit.

次要结局

未报告次要终点

研究者

发起方

Harvard School of Public Health (HSPH)

申办方类型

Other

责任方

Principal Investigator

主要研究者

Max Essex

Study Chair

Harvard School of Public Health (HSPH)

相似试验

已完成

2 期

ARVs to Prevent Breastmilk HIV:Viral and Immune ResponsesHIV Infections

NCT00167674University of Washington58

进行中（未招募）

不适用

Prévention de la transmission du VIH-1 de la mère à l’enfant sans utilisation d’analogue nucléosidique - PRIMEVA

EUCTR2006-006200-11-FRAgence nationale de recherches sur le sida et les hépatites virales. ANRS

尚未招募

2 期

Prevention of CMV infection via breast milk by Microwave treatment.

JPRN-UMIN000040246Showa University of Medicine32

已完成

不适用

Primary HIV Prevention in Pregnant and Lactating Ugandan WomenPrimary Prevention of HIV Acquisition

NCT01882998University of California, San Francisco1,230

招募中

不适用

PROJECT ¿SABES?”

PER-066-14Centro de Investigacion del Cancer Fred Hutchinson, Estados Unidos,2,138