A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure for Individuals on Tenofovir, Lamivudine, and Dolutegravir (TLD) in Sub-Saharan Africa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 648
- 试验地点
- 3
- 主要终点
- Viral suppression at 48 weeks
研究概览
简要总结
The RESOLVE trial is an open, parallel arm, randomized clinical trial which aims to determine the optimal strategy for management of virologic failure on antiretroviral therapy (ART) with tenofovir, lamivudine, and dolutegravir (TLD) in sub-Saharan Africa. The primary outcome of interest will be viral suppression to <50 copies/mL at 48 weeks using the FDA snapshot definition. The study will be conducted in Uganda and South Africa.
详细描述
The RESOLVE trial is an open, parallel arm, randomized clinical trial which will be conducted at public-sector HIV clinics in Uganda and South Africa. We will enroll individuals with HIV age 15 and above who have had two HIV-1 RNA viral load results >1,000 copies/mL while on TLD and who have been on TLD for at least 12 months. Participants will be randomized using an equal allocation ratio of 1:1:1 across three study arms: a) Standard of Care (regimen guided by genotypic resistance tests and care as per guidelines in Uganda; and with regimen selection and possible genotypic resistance testing (GRT) and care as per guidelines in South Africa), 2) Individualized Care with regimen choice based on results of genotypic resistance tests and urine tenofovir adherence assays, or 3) Immediate Switch to PI-based second-line ART. Randomization will be stratified by clinic, prior exposure to non-nucleoside reverse transcriptase inhibitors, and virologic failure history. We will follow participants for one year with study visits at enrollment, Week 24, and Week 48. The primary outcome of interest will be viral suppression to <50 copies/mL at 48 weeks using the FDA snapshot definition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 15 years and above
- •Enrolled in HIV care at one of the study clinics
- •History of two HIV-1 RNA viral load measurements >1,000 copies/mL while on TLD
- •On TLD for at least 12 months
- •Lives within 100 kilometers of study clinic
- •Pregnant women are eligible for enrollment.
排除标准
- •Plans to transfer out of the clinic within the next 48 weeks
- •Plans to move out of the study catchment area within the next 48 weeks
- •As determined by chart review, we will exclude those with known virologic failure on protease inhibitors or exposure to integrase strand transfer inhibitors other than dolutegravir.
结局指标
主要结局
Viral suppression at 48 weeks
时间窗: 48 weeks post-enrollment (visit window spanning 42 to 54 weeks post-enrollment)
A plasma HIV-1 RNA viral load \<50 copies/mL (FDA-snapshot definition)
次要结局
未报告次要终点
研究者
Suzanne McCluskey
Assistant Professor
Massachusetts General Hospital