Parallel Comparison of Tenofovir and Emtricitabine/Tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,758
- 试验地点
- 9
- 主要终点
- Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants
研究概览
简要总结
Randomized, blinded, placebo-controlled trial to demonstrate if pre-exposure prophylaxis decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1 discordant couples.
详细描述
HIV-1 uninfected individuals within HIV-1 discordant partnerships are at high-risk for HIV-acquisition. The majority of HIV-1 transmissions to adults in Africa occur within stable, HIV-1 discordant couples.
Pre-exposure chemoprophylaxis, in which an HIV-1 uninfected individual at high risk for contracting HIV-1 takes antiretroviral medications to maintain blood and genital drug levels sufficient to prevent HIV-1 acquisition, has been proposed as a potential HIV-1 prevention strategy.
This study was a randomized, blinded, placebo-controlled trial to demonstrate if pre-exposure prophylaxis decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1 discordant couples. The HIV-1 uninfected partner was randomized in a 1:1:1 ratio to one of three arms: once daily Tenofovir Disoproxil Fumarate (TDF), Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) or Placebo.
Couples were followed up to 36 months; the HIV uninfected partner attended monthly visits and the HIV infected partner quarterly visits. All participants received a comprehensive package of HIV prevention services including individual and couples counseling, free condoms, and male circumcision referrals.
Participants who seroconverted during follow-up stopped the study drug but continued with follow-up.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tenofovir Disoproxil Fumarate (TDF)
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
干预措施: Tenofovir Disoproxil Fumarate (TDF) (Drug)
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
干预措施: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) (Drug)
Placebo
Placebo TDF + Placebo FTC/TDF orally, once daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants
时间窗: Up to 36 months
The efficacy of once daily PrEP in preventing HIV-1 acquisition among uninfected heterosexuals in HIV-1 discordant partnerships, measured by calculating the HIV incidence per 100 person-years in each of three arms.
Number of Participants With Serious Adverse Events (SAEs)
时间窗: Up to 36 months
Safety of daily TDF or FTC/TDF among HIV-1 uninfected individuals randomized to TDF or FTC/TDF compared to those randomized to placebo measured as the number of participants with Serious Adverse Events (SAEs) during follow-up.
次要结局
- Length Among Infants Born to Female Participants Taking Study Drug(up to 12 months)
- Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.(Up to 36 months)
- Study Drug Adherence: Self-reported Missed Doses of Study Drug(Up to 36 months)
- Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC(Up to 36 months)
- Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up(Up to 36 months)
- Prevalence of Unprotected Sex During Follow-up(Up to 36 months)
- Weight Among Infants Born to Female Participants Taking Study Drug(up to 12 months)
- Head Circumference Among Infants Born to Female Participants Taking Study Drug(up to 12 months)
- Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug.(Up to 36 months)
研究者
Connie Celum
Professor, School of Medicine, Global Health
University of Washington