Doravirine Concentrations and Antiviral Activity in Genital Fluids in HIV-1 Infected Individuals
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Concentration of Doravirine in Seminal Plasma Fluid
研究概览
简要总结
This study aims to evaluate the ability of Doravirine to penetrate the genital tract and suppress viral replication and provide evidence for the use of Doravirine as part of treatment strategies as prevention.
详细描述
Objectives:
- To determine Doravirine concentrations in seminal plasma and cervicovaginal fluid in HIV-1 infected male and female individuals receiving antiretroviral therapy (ATR) with Doravirine plus Descovy®.
- To evaluate HIV-1 viral load in seminal plasma and cervicovaginal fluid in HIV-1 infected male and female individuals receiving ART with Doravirine plus Descovy®.
Study Phase:
Phase II
Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Asymptomatic, HIV-1 infected individuals ≥ 18 years of age.
- •Be on a stable ART consisting of TAF/FTC, tenofovir disoproxil fumarate/emtricitabine or abacavir/lamivudine, plus an non-nucleoside reverse transcriptase inhibitor, a boosted protease inhibitor or an integrase inhibitor, continuously for at least 3 consecutive months preceding the screening visit.
- •Plasma HIV-1 RNA <40 copies/mL for at least 6 months at the Screening visit.
- •Signed and dated written informed consent prior to inclusion.
- •Female Subjects of Childbearing Potential must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit throughout the duration of the study.
排除标准
- •Severe hepatic impairment (Child-Pugh Class C)
- •Ongoing malignancy
- •Active opportunistic infection
- •Resistance to any of the antiretroviral (ARV) included in the study or history of virologic failure with risk of resistance selection to any of the study drugs.
- •Any verified Grade 4 laboratory abnormality
- •ALT or AST ≥ 3xULN and/or bilirubin ≥ 1.5xULN
- •Severe renal impairment (Estimated creatinine filtration rate <50mL/min).
- •Females who are pregnant (as confirmed by positive serum pregnancy test) or breastfeeding.
研究组 & 干预措施
Doravirine + Descovy® TAF/FTC
Doravirine (MK-1439) 100 mg administered orally once daily in combination with Tenofovir alafenamide (TAF) and emtricitabine (FTC) co-formulated as single tablet (Descovy® TAF/FTC 25/200 mg) and administered orally once daily during 16 weeks
干预措施: Doravirine (Drug)
Doravirine + Descovy® TAF/FTC
Doravirine (MK-1439) 100 mg administered orally once daily in combination with Tenofovir alafenamide (TAF) and emtricitabine (FTC) co-formulated as single tablet (Descovy® TAF/FTC 25/200 mg) and administered orally once daily during 16 weeks
干预措施: Descovy (Drug)
结局指标
主要结局
Concentration of Doravirine in Seminal Plasma Fluid
时间窗: 8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC
Concentration of Doravirine in seminal plasma fluid in HIV-1 infected male individuals
Concentration of Doravirine in Cervicovaginal Fluid
时间窗: 8 weeks after switching to Doravirine plus TAF/FTC
Concentration of Doravirine in cervicovaginal fluid in HIV-1 infected female individuals
Number of Participants With HIV-1 RNA Seminal Plasma <40 Copies/mL
时间窗: 8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC
Number of participants with HIV-1 RNA seminal plasma \<40 Copies / mL of HIV measured by real-Time Reverse Transcriptase Polymerase Chain Reaction Amplification
Quantification of Participants With HIV-1 RNA <40 Copies / mL in Cervicovaginal Fluid
时间窗: 8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC
Number of participants with HIV-1 RNA cervicovaginal fluid\<40 Copies / mL of HIV measured by real-Time Reverse Transcriptase Polymerase Chain Reaction Amplification
次要结局
未报告次要终点
研究者
Daniel Podzamczer
Chief of the HIV and STD Unit (Infectious Disease Service)
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia