ADORE: A Single-arm, Phase 3, Pilot Study Investigating the Efficacy of Doravirine in Adults Living With HIV Experiencing Virological Failure on First-line Efavirenz-based Antiretroviral Therapy With Non-nucleoside Reverse Transcriptase Inhibitor Resistance
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Proportion of participants with undetectable plasma HIV-1 RNA levels (<50 copies/mL) at week 24
研究概览
简要总结
This is a pilot study investigating the efficacy of Doravirine (DOR) in combination with Lamivudine (3TC) and Tenofovir Disoproxil Fumarate (TDF) administered over 48 weeks in adults living with HIV-1 experiencing virological failure on first-line Efavirenz-based antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor resistance
详细描述
This is a single-arm, phase 3 pilot study investigating the efficacy of Doravirine (DOR) in combination with Lamivudine (3TC) and Tenofovir Disoproxil Fumarate (TDF) administered over 48 weeks in adults living with HIV-1 experiencing virological failure on first-line Efavirenz-based antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor resistance.
Approximately 25 male and female participants 18 years and older infected with HIV-1 and experiencing virological failure on efavirenz-based ART will be administered a once-daily, fixed-dose combination of doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg (DOR/3TC/TDF). The study includes screening and baseline visits, 4 study visits from Week 4 to Week 36, and an end of study visit at Week 48.
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
- •Adults living with HIV-1, 18 years and older
- •Viral load 5000 - 60 000 copies/mL on first-line efavirenz-based antiretroviral therapy
- •HIV genotype resistance test with first generation NNRTI resistance (e.g. K103N, Y181C, etc as listed in the protocol)
- •CD4 > 200 cells/uL
- •Creatinine clearance > 50 mL/min
- •Body mass ≥ 35 kg.
排除标准
- •Resistance to TDF on genotype (K65R)
- •"Significant resistance" to doravirine, denoted by a Stanford Score ≥ 15 on genotype
- •Virologic failure on any other regimen
- •Women who are pregnant at the time of the screening or enrolment visits
- •Active tuberculosis and/or are on anti-tuberculous therapy at the time of the screening or enrolment visits
- •Taking and cannot discontinue prohibited concomitant medications listed in protocol at least two weeks prior to the enrolment visit and for the duration of the study period.
研究组 & 干预措施
Doravirine
Once-daily, fixed-dose combination of doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg (DOR/3TC/TDF).
干预措施: Doravirine/Lamivudine/Tenofovir (Drug)
结局指标
主要结局
Proportion of participants with undetectable plasma HIV-1 RNA levels (<50 copies/mL) at week 24
时间窗: 24 weeks
The proportion of participants with undetectable plasma HIV-1 RNA levels at Week 24 will be recorded.
次要结局
- Proportion of patients with undetectable plasma HIV-1 RNA levels (<50 copies/mL) at weeks 4, 12 and 48(At week 4, 12, 48)
- Change from baseline in plasma CD4 levels at weeks 24 and 48(At week 24, 48)
- Emergence of antiretroviral resistance mutations in participants with virological failure(48 weeks)
研究者
Professor Francois Venter
Divisional Director: Ezintsha
University of Witwatersrand, South Africa