A Phase IV Open-Label Evaluation of Safety, Tolerability and Patient Acceptance of Raltegravir (MK-0518) Combined With a Fixed-Dose Formulation of Tenofovir Following Potential Exposure to HIV-1
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Medication Regimen Completion Rates
研究概览
简要总结
This study will evaluate how safe and tolerable a combination of taking three-drugs will be for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in HIV uninfected adults.
详细描述
This study will evaluate a three drug regimen in the form of two pills which will be taken for 28 days for the prevention of HIV infection. Two drugs are combined in an FDA-approved pill called TRUVADA, containing the HIV medications, tenofovir disoproxil fumarate 300mg and emtricitabine 200mg, taken as one pill once a day. The third drug is a new formulation, raltegravir 400mg pill taken twice a day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV uninfected on the basis of a negative HIV Rapid Test, EIA or Western blot, and a negative HIV-1 RNA assay
- •Possible non-occupational exposure to HIV-1, recent enough to permit receiving the first dose of study medication within 72 hours from the end of the exposure.
- •Able to understand the study procedures and willing to sign informed consent
排除标准
- •Any active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures.
- •Pregnancy.
- •Chronic hepatitis B infection, diagnosed by either positive serum HBsAg or positive serum HBV DNA; or prior lamivudine therapy for hepatitis B.
- •Creatinine clearance less than 50 mL/min as calculated by Cockcroft-Gault formula.
- •Unwillingness to participate in study procedures, including Mental Health referral and intervention.
- •Known intolerance or allergy to tenofovir DF, emtricitabine or raltegravir.
- •Use of prohibited concomitant medication: dilantin, phenobarbital and rifampin which cannot be used with raltegravir.
研究组 & 干预措施
Group 1
TRUVADA
干预措施: TRUVADA + Raltegravir (Drug)
结局指标
主要结局
Medication Regimen Completion Rates
时间窗: 28 days
Pill counts performed at 14 and 28 days
Number of HIV-1 Infected Participants
时间窗: 90 days
Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected
次要结局
未报告次要终点
研究者
Kenneth H. Mayer, MD
Medical Director, The Fenway Institute
Fenway Community Health