Study of the Safety and Efficacy of Daily Tenofovir Disoproxil Fumarate for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1,200
- 试验地点
- 3
- 主要终点
- Adverse drug reactions in the tenofovir and placebo arms
研究概览
简要总结
This study will test whether taking a pill of tenofovir (an antiretroviral medicine) is safe for sexually-active young adults in Botswana without HIV infection and whether it will reduce their risk of getting an HIV infection.
详细描述
Twelve hundred healthy, sexually active women and men, 18-29 years old, without HIV infection will be enrolled in Francistown and Gaborone, Botswana. They will be 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 will be randomized to receive either Tenofovir or a placebo pill to take once a day. Volunteers will be 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 will receive 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 will be 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
- Double
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •citizen of Botswana 18-29 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 effective contraception
- •living within 1 hours travel of study clinic
- •pass comprehension test
- •willing and able to give informed consent
排除标准
- •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
结局指标
主要结局
Adverse drug reactions in the tenofovir and placebo arms
HIV incidence in the tenofovir and placebo arms
次要结局
- Changes in levels of unprotected sex during the trial
- Adherence to medication
- Antiretroviral (ARV) resistance patterns in seroconverters
- Viral set point in seroconverters