Combined HIV Adolescent PrEP and Prevention: On Demand Pre-exposure Prophylaxis to Provide Protection From HIV in Men - Using Foreskin Tissue to Estimate Protection (Phase II)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- HIV Infection free
研究概览
简要总结
To compare the effect of different PrEP drugs (FTC-TDF and FTC-TAF), doses and timing of doses on p24 antigen level in resected foreskin tissue following HIV exposure ex vivo challenge.
详细描述
- Investigate the timing and dose of FTC-TDF and FTC-TAF as oral PrEP and in vitro PEP (applied directly to removed foreskin tissue) required to prevent ex vivo HIV infection in foreskin tissue and blood using the explant model
- Determine blood, rectal fluid and foreskin tissue concentrations of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection
- Evaluate inflammation, cellular activation, foreskin mucosal integrity, gene expression and microbiome in foreskin tissue following oral in vivo PrEP and in vitro PEP
- Evaluate the efficacy of in vitro post exposure dosing with PrEP in protection against ex vivo HIV infection using the explant model
- To investigate sexual behaviour, PrEP acceptability and feedback on HIV prevention trials implementation
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
- None
入排标准
- 年龄范围
- 13 Years 至 24 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participants must satisfy all the following criteria within 21 days prior to their circumcision visit:
- •Clinically eligible for either forceps guided, or dorsal slit circumcision
- •The ability to understand and sign a written informed consent form by participant (and participant's legal guardian if younger than 18 years) prior to participation in any study procedures and to comply with all trial requirements
- •Male sex at birth
- •Age 13- 24 years
- •Haemoglobin >9g/dL
- •Weight >35Kg
- •Two negative rapid HIV antibody tests results (manufactured by different companies), dating from 21 days or less prior to VMMC
- •Two locator information details (including physical address, telephone contacts, email) for contacting of either patient or their parent
排除标准
- •Any significant acute or chronic medical illness and current therapy that in the opinion of the site investigator would preclude receipt either of investigational products, or VMMC
- •Any evidence that participant is not suitable for VMMC
研究组 & 干预措施
Arm 2: FTC-TDF
FTC-TDF one day, 5 hours before circumcision.
干预措施: Tenofovir (Drug)
Arm 3: FTC-TDF
FTC-TDF one day, 21 hours before circumcision.
干预措施: Tenofovir (Drug)
Arm 4: FTC-TDF
FTC-TDF two days, 5 hours before circumcision.
干预措施: Tenofovir (Drug)
Arm 5: FTC-TDF
FTC-TDF two days, 21 hours before circumcision.
干预措施: Tenofovir (Drug)
Arm 6: FTC-TAF
FTC-TAF one day, 5 hours before circumcision.
干预措施: Tenofovir (Drug)
Arm 7: FTC-TAF
FTC-TAF one day, 21 hours before circumcision.
干预措施: Tenofovir (Drug)
Arm 8: FTC-TAF
FTC-TAF two days, 5 hours before circumcision.
干预措施: Tenofovir (Drug)
Arm 9: FTC-TAF
FTC-TAF two days, 21 hours before circumcision.
干预措施: Tenofovir (Drug)
结局指标
主要结局
HIV Infection free
时间窗: 15 days
We will ascertain the proportion of patients' foreskin tissue that is not infected with HIV 15 days following our ex-vivo HIV challenge. We will use the concentration of p24 antigen (pg/mL) at day15 and also report the slope of the p24 curves from day 3 to 15 (pg/mL per day) and also the AUC day 3 to 15 (pg/mL days).
次要结局
- Blood PrEP Concentrations(1 year)
- Foreskin tissue PrEP concentration(1 year)
- Timing(1 year)
- Dose(1 year)
- Efficacy of post-exposure PrEP(1 year)
- Rectal Fluid PrEP concentrations(1 year)