Effects of the Anti-HIV Pill Truvada on Gene Transcription in the Gastrointestinal Tract of HIV-uninfected Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Global Transcriptome Analysis
研究概览
简要总结
As explained in detail in a recently published hypothesis article (Hladik F. A new hypothesis on HIV cure. F1000Research, 4:77 (2015)), the investigators hypothesize that NRTI drugs may reduce the likelihood of HIV eradication by promoting the survival of cells with integrated provirus. In this study, the investigators will test whether daily oral use of two NTRI drugs, tenofovir and emtricitabine (Truvada Pill), induces changes in the upper and lower gut mucosa that are congruent with supporting this hypothesis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •• HIV-negative
- •Male gender at birth
- •Age ≥18 years old
- •Intent to initiate PrEP in the next 1-2 months.
- •Willingness and ability to provide informed consent for study participation
- •Willingness to undergo all required study procedures
排除标准
- •Creatinine clearance < 60mL/min
- •Platelet count below the normal reference
- •Coagulation (PT/PTT) tests above the normal reference
- •Any prior use of PrEP
- •Use of PEP within 30 days prior to study entry
- •Receipt of
- •anti-coagulant medications (e.g. warfarin). Aspirin is allowable.
- •Systemic corticosteroid medications
- •Non-steroidal anti-inflammatory drug (NSAID) use >2 days/week
- •Signs or symptoms of acute HIV infection within 14 days of study entry
- •No availability of another person who will drive participant home on days of entry and follow-up procedures.
- •Plan to leave the Seattle area in the subsequent 2.5 months
- •Any condition or substance use that, in the opinion of the study investigator, would interfere with study participation.
研究组 & 干预措施
Cohort
All subjects will undergo all procedures
干预措施: Upper endoscopy (Procedure)
Cohort
All subjects will undergo all procedures
干预措施: Anoscopy (Procedure)
Cohort
All subjects will undergo all procedures
干预措施: Truvada (Drug)
结局指标
主要结局
Global Transcriptome Analysis
时间窗: 2-3 months after initiating HIV Pre-exposure prophylaxis
Global transcriptome analysis tests for expression changes of any possible gene across the entire human genome in response to Truvada PrEP. The main outcome of such an analysis is the number of genes significantly changing in expression between before and after treatment. We will report that Truvada PrEP up-regulates X number of genes and down-regulates Y number of genes.
次要结局
未报告次要终点
研究者
Joanne Stekler, MD MPH
Associate Professor, Division of Allergy & Infectious Diseases
University of Washington