NCT02151838已完成不适用
The Thai Red Cross AIDS Research Centre
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- HIV-infected pregnant women
研究概览
简要总结
To assess the safety and the efficacy of Highly Active Anti-Retroviral Treatment (HAART) for the Prevention of Mother-To-Child Transmission of HIV (PMTCT)
详细描述
- To describe characteristics of HIV-infected pregnant women who request HAART from the Thai Red Cross Society PMTCT (TRCS PMTCT) program
- To study adverse pregnancy outcomes among HIV-infected pregnant women who receive HAART
- To study adverse events in infants born to women who receive HAART during pregnancy
- To evaluate risk factors for HAART-related toxicities and for perinatal HIV transmission
- To establish the pilot model of care for HIV-infected pregnant women in middle income country
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Volunteers meeting all of the following criteria will be considered eligible for enrollment in the study:
- •HIV-infected pregnant women (as defined by the hospital)
- •Choose to start HAART according to protocol and do not want to receive antiretroviral treatment provided by the other health care systems
- •Understand the study and sign informed consent form. Persons who cannot read will have the consent form read to them by a study staff and they can give informed consent by using thumb print.
- •Availability for follow-up for the planned study duration
排除标准
- •Volunteers meeting any of the following criteria will be excluded from the study:
- •1.Persons who have a history of a medical or psychiatric disorder by interview and physical examination according to standard practices, that in the judgment of the treating physician, would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.
结局指标
主要结局
HIV-infected pregnant women
时间窗: 18 months
Choose to start HAART according to protocol and do not want to receive antiretroviral treatment provided by the other health care systems
次要结局
未报告次要终点
研究者
研究点 (1)
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