A Pilot Project to Assess the Safety and Tolerability of Truvada Plus Raltegravir as Post-exposure Prophylaxis (nPEP) Following Sexual Exposure to Human Immunodeficiency Virus (HIV)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months
研究概览
简要总结
This study will evaluate the safety and tolerability of the combination of truvada and raltegravir given for 28 days for the prevention of HIV infection.
详细描述
Non-Occupational Post-Exposure Prophylaxis (nPEP) after sexual exposure to HIV is recommended by the Centers for Disease Control (CDC). Although no efficacy data exist for Post-Exposure Prophylaxis (PEP) after sexual exposure, PEP has been shown to reduce HIV transmission in other exposure situations such as occupational exposures and mother-to-child transmission. The role in nPEP of the newer agents approved for the treatment of HIV infection remains unknown. The anti-HIV drug raltegravir works early in the life cycle of the virus, before it integrates with human DNA. It has few side effects and drug interactions what makes it an ideal drug for an nPEP regimen.
We aim to asses the safety and tolerability of the combination of truvada and raltegravir for nPEP.
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
- 否
入选标准
- •Patients must be at least 18 years of age
- •HIV uninfected on the basis of a negative HIV rapid test, EIA or Western blot, and without any signs or symptoms of acute HIV infection
- •Able to understand and provide consent
- •High-Risk Exposure Characteristic (One or more of the below, unprotected or with failed condom use):
- •Receptive Anal Intercourse
- •Insertive Anal Intercourse
- •Receptive Vaginal Intercourse
- •Insertive Vaginal Intercourse
- •Receptive Oral Intercourse with Intraoral Ejaculation with known HIV+ source
- •High-Risk Source (One or more of the below):
- •Known HIV positive
- •Sexual perpetrator Partner of one of the above
- •Exposure within 72 hours of presentation
- •Not known to be HIV-1 positive
- •No countermanding concomitant medications or allergies
排除标准
- •Patients <18 years of age
- •Unable to understand and provide consent
- •Non-occupational exposure to HIV-1 not recent enough to commence the first dose of study medication within 72 hours from the exposure
- •Known to be HIV positive
- •Any condition which in the opinion of the intake provider will seriously compromise the patient's ability to comply with the protocol, including adherence to nPEP medication
- •Demonstrated HIV-1 positive on rapid testing
- •Unwillingness to commit to barrier-method (male and/or female condom) use until HIV negative status is confirmed 6 months after exposure
- •Unwillingness of breast-feeding women to transition to formula feeding
- •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 or other therapy for hepatitis B
- •Creatinine clearance less than 30 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
Truvada and Raltegravir
Single arm
干预措施: Truvada (Drug)
Truvada and Raltegravir
Single arm
干预措施: Raltegravir (Drug)
结局指标
主要结局
Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months
时间窗: 6 months
This measure assesses whether the combination of Truvada and Raltegravir prevents the acquisition of HIV at six months among HIV-negative people who have been exposed to HIV.
次要结局
- Number of Participants Exhibiting Clinical or Laboratory Abnormalities Resulting From the 28-day Exposure to the Antiretroviral Drugs Being Explored in This Study(28 days)
- Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study(28 days)
研究者
Karen Vigil
Assistant Professor - Internal Medicine
The University of Texas Health Science Center, Houston