A Single Arm, Phase 3 Study, Exploring the Safety of Doravirine-based First-line Antiretroviral Therapy for Women of Reproductive Potential Living With HIV, a Pilot Switch Study Strategy in South Africa
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- Changes in fasting lipids from baseline to Week 48
研究概览
简要总结
This is a pilot study investigating the safety of Doravirine (DOR) in combination with Lamivudine (3TC) and Tenofovir Disoproxil Fumarate (TDF) administered over 48 weeks in women of reproductive potential living with HIV-1 switched from Efavirenz or Dolutegravir-based antiretroviral therapy on metabolic and neuropsychiatric outcomes.
详细描述
This is a pilot, open label, single-arm, single centre, phase 3, switch study exploring the safety of of Doravirine (DOR) in combination with Lamivudine (3TC) and Tenofovir Disoproxil Fumarate (TDF) administered over 48 weeks in women of reproductive potential living with HIV-1 switched from Efavirenz or Dolutegravir-based antiretroviral therapy. The metabolic and neuropsychiatric outcomes among women (and their infants) in a representative African female population of reproductive potential will be investigated.
Approximately 100 women aged between 18 and 49 years old 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 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females, aged 18-49 years and ≥ 40 kg
- •On a first-line EFV or DTG-containing regimen for at least six months and not more than 3 years
- •Plasma HIV-1 RNA < 50 copies/mL in last 60 days
- •Calculated creatinine clearance (CrCl) > 50 mL/min (Cockcroft-Gault formula)
- •Baseline weight measurement available at ART initiation.
排除标准
- •Virological failure on any other regimen
- •Women who are pregnant at the time of the screening or enrolment visits or have had a pregnancy gestation ≥ 28 weeks in the preceding 2 years
- •Active tuberculosis and/or are on antituberculosis 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 (see potential drug interactions section for list).
研究组 & 干预措施
Delstrigo
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 Disoproxil Fumarate (Drug)
结局指标
主要结局
Changes in fasting lipids from baseline to Week 48
时间窗: 48 weeks
Changes in fasting lipids from baseline to Week 48 assessed using lipid profile blood test
The proportion of participants with neuropsychiatric adverse events (AEs)
时间窗: 48 weeks
The proportion of participants with neuropsychiatric adverse events (AEs) in 3 pre-specified categories (dizziness, sleep disorders/ disturbances, and altered sensorium) at Week 48
Changes in body mass index from baseline to Week 48
时间窗: 48 weeks
Changes in body mass index from baseline to Week 48 assessed
Changes in weight from baseline to Week 48
时间窗: 48 weeks
Changes in weight from baseline to Week 48 assessed
Changes in glucose from baseline to Week 48
时间窗: 48 weeks
Changes in glucose from baseline to Week 48 assessed using blood test
次要结局
- Emergence of antiretroviral resistance mutations in participants with virological failure(48 weeks)
- The proportion of participants with detectable plasma HIV-1 RNA levels (≥ 50 copies/mL)(At week 24, 48)
- The proportion of participants with neuropsychiatric adverse events (AEs) in 3 pre-specified categories(24 weeks)
- Changes in glucose from baseline to week 24(24 weeks)
- Changes in fasting lipids from baseline to week 24(24 weeks)
- Changes in weight and from baseline to week 24(24 weeks)
- Changes in body mass index from baseline to week 24(24 weeks)
- The proportion of infants evaluated for HIV-positive tests using HIV DNA polymerase chain reaction test (PCR)(48 weeks)
- Changes in quality of life from baseline(At weeks 24, 48)
- Median adherence by each adherence measure(At weeks 24, 48)
研究者
Professor Francois Venter
Divisional Director of Ezintsha
University of Witwatersrand, South Africa