A Phase IV Open-label Evaluation of Safety, Tolerability and Patient Acceptance of Atazanavir Boosted With Ritonavir Combined With a Fixed-dose Formulation of Tenofovir DF and Emtricitabine for nPEP Following Potential Exposure to HIV-1
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Safety of Regimen - Symptoms
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
Participants are given a regimen containing tenofovir disoproxil fumarate (TDF) 300mg and emtricitabine (FTC) 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily,for 28 days.
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
- •Age of 18 at time of first visit.
- •HIV uninfected on the basis of a negative HIV Rapid Test
- •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.
排除标准
- •Women who are actively trying to become pregnant.
- •Pregnancy and/or Breastfeeding.
- •Known self report of Chronic Hepatitis B infection or prior antiretroviral therapy for hepatitis B.
- •Known intolerance or allergy to study drugs.
研究组 & 干预措施
Atazanavir, Ritonavir, Truvada
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir
干预措施: Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir (Drug)
结局指标
主要结局
Safety of Regimen - Symptoms
时间窗: Visit 3- Day 30
Number of subjects who experienced moderate-to-severe symptoms on the symptom-directed physical exam at or before visit 3.
Safety of Regimen - Adverse Events/Serious Adverse Events Considered Related
时间窗: visit 3 - day 30
Number of subjects who experience adverse or serious adverse events that are considered related to the use of the drug regimen at or before visit 3.
Safety of Regimen - Unsafe Biological Test
时间窗: visit 3 - day 30
Number of subjects who have an unsafe biological test result as part of the laboratory screen for safety levels (e.g., CBC, Creatinine, etc.) at or before visit 3.
次要结局
- Awareness of NPEP(Visit 2- Day 14)
- Adherence - Degree of Adherence(Visit 1- Day 28)
- Adherence Rate - Overall(Visit 3- Day 30)
- Prior nPEP Use(Visit 2- Day 14)
研究者
Kenneth H. Mayer, MD
Medical Director, The Fenway Institute
Fenway Community Health