Study of the Safety and Efficacy of Daily Oral Antiretroviral Use for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,219
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms
研究概览
简要总结
This study tested whether taking a pill of tenofovir and emtricitabine (two antiretroviral medicines) was safe for sexually-active young adults in Botswana without HIV infection and whether it reduced their risk of getting an HIV infection.
详细描述
Twelve hundred and nineteen healthy, sexually active women and men, 18-39 years old, without HIV infection were enrolled in Francistown and Gaborone, Botswana. They were provided with free male and female condoms, repeated individualized risk-reduction counseling, diagnosis and treatment of sexually transmitted diseases, and women will be provided with a choice of effective family planning methods. In addition, volunteers were randomized to receive either Tenofovir and emtricitabine (in a single pill) or a placebo pill to take once a day. Volunteers were seen monthly for at least 12 months to monitor for side effects and toxicities and to test their HIV status. Persons who become HIV infected during the trial received ongoing supportive counseling, CD4 and viral load monitoring, education about HIV infection/disease, and access to HIV care including free antiretrovirals when clinically indicated. Volunteer safety was monitored by a local ethics committee, Centers for Disease Control Institutional Review Board (CDC IRB) and an independent data safety and monitoring board
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •citizen of Botswana 18-39 years old
- •sexually active
- •HIV uninfected
- •Hepatitis B and C uninfected
- •Calculated creatinine clearance >= 60 mL/min
- •hemoglobin >= 8 gm/dL
- •ALT and AST <= 2x ULN
- •total bilirubin <= 1.5 mg/dL
- •total serum amylase <= 1.5x ULN
- •Serum phosphorus >= 2.2 mg/dL
- •willing to use hormonal contraception (females)
- •living within 1 hours travel of study clinic
- •pass comprehension test
- •willing and able to give informed consent
排除标准
- •18-20 without parent/guardian consent
- •history of significant renal or bone disease
- •any chronic illness requiring ongoing prescription medication
- •pregnant or breastfeeding
- •planning to move away from site in the next year
- •participating in another HIV prevention or vaccine safety trial
- •any other clinical condition or prior therapy that, in the opinion of the study physician, would make the volunteer unsuitable for the study or unable to comply with the dosing requirements
研究组 & 干预措施
TDF-FTC,condoms,adh/risk counseling
Eligible participants were randomized to oral Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg (TDF-FTC) once daily in the form of a single tablet. The ratio of randomization was 1:1. Participants randomized to the active arm received male and female condoms, risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events.
干预措施: Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg (Drug)
Placebo,condoms,adh/risk counseling
Eligible participants were randomized to the placebo arm and received placebo oral tablets that were visually identical to the TDF-FTC tablet and taken once daily. The placebo tablets contained no active ingredients. The ratio of randomization was 1:1. Participants randomized to the placebo arm received male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms
时间窗: Monthly, for up to 3 years
Study visits were scheduled every 30 days until completion of the study, and participants were instructed to return to the clinic for evaluation in the event of an illness. Participants reported any adverse effects at monthly visits and interim visits.
HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms
时间窗: Monthly, for up to 3 years
Study visits were scheduled every 30 days until completion of the study and during monthly study visits, we performed testing for HIV infection. At completion of the study, we tested all participants for HIV infection, using an enzyme-linked immunosorbent assay (ELISA).The primary efficacy end point was the difference in the rates of HIV infection between participants assigned to receive TDF-FTC and those assigned to receive placebo. The initial efficacy analysis included all study participants who were randomly assigned to receive a study medication (intention-to-treat cohort).
次要结局
- Antiretroviral (ARV) Resistance Patterns in Seroconverters(At time HIV infection diagnosed,1 month post-time of HIV infection diagnosis, and 6 months post-time of HIV infection diagnosis)
- CD4 Evaluation After HIV Seroconversion(1-year post seroconversion)
- Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts(12 months)
- Rates of Adherence to Study Medication(36 months)