NCT01865786已完成不适用
A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication Nested in the Antiretroviral Pregnancy Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Presence or absence of congenital malformations among infants born to HIV-1 uninfected women on FTC/TDF for PrEP
研究概览
简要总结
This is a prospective, observational study to describe pregnancy outcomes among HIV-1 uninfected pregnant women who are taking emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) (Truvada®) for a pre-exposure prophylaxis (PrEP) indication nested in the Antiretroviral Pregnancy Registry (APR).
Information on subjects is provided to the APR prospectively (prior to the outcome of the pregnancy being known) through their healthcare provider, with follow-up obtained from the healthcare provider following determination of the pregnancy outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women
- •Part of the prospective arm of the APR Target Group Inclusion Criteria
- •HIV-1 Negative
- •Choosing to remain on FTC/TDF for PrEP during pregnancy or,
- •Choosing to discontinue FTC/TDF for PrEP during pregnancy Comparison Group Inclusion Criteria
- •HIV-1 Positive
- •On antiretroviral therapy
排除标准
- •This is an observational nested study and will monitor all reported exposures without intervention/exclusion.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
Presence or absence of congenital malformations among infants born to HIV-1 uninfected women on FTC/TDF for PrEP
时间窗: Year 1
次要结局
- Pregnancy outcomes in HIV-1 uninfected women who choose to continue or discontinue FTC/TDF for PrEP during their pregnancy as well as HIV-infected women treated with antiretrovirals(Years 1, 2, and 3)
研究者
研究点 (1)
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