An Open Label Study Evaluating the Safety and Efficacy of Switching From Rilpivirine/Emtricitabine/Tenofovir Alafenamide in Combination With Dolutegravir, to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Combination With Doravirine, in Male HIV+ Subjects > 45 Years With Multi-drug Resistant Virus and Virologic Suppression (Documented With at Least One Viral Load Result < 50 Copies Per mL) During the Last 6 Months on Current Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Viral Suppression
研究概览
简要总结
The current study proposal is an open label observational trial for maintenance of virologic suppression, and is designed as a non- inferiority switch trial. The study will involve approximately 30 patients, which includes a PK arm of approximately 10 patients. The study will also include secondary outcomes of quality of life (QOL) and weight changes
Hypothesis:
Patients with prior NUC or NNRTI resistance (but not to rilpivirine or doravirine) will maintain their virologic suppression after a drug regimen switch from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine. The switch therapy will avoid food interactions, and will be well tolerated by subjects.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •HIV positive Males, age 45 or older
- •Any genotypic or phenotypic resistance except k65R, 69 insertion, integrase resistance, or resistance to rilpivarine or doravirine.
- •Receiving combination antiretroviral regimen of rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir > 12 months and with viral load <50 copies/ mL on at least one occasion within the six months prior to switch.
- •Suppressed viral load as defined by one plasma HIV RNA level < 50 copies/mL within previous 6 months.
- •Capable of providing informed consent
排除标准
- •Any current or prior integrase inhibitor resistance
- •Nucleoside reverse transcriptase (NRTI) mutation 69 insertion or k65R mutation
- •Documented second generation non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance (rilpivirine or doravirine)
研究组 & 干预措施
Biktarvy + Doravirine Switch
bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets + doravirine 100mg tablets taken orally once per day
干预措施: Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch (Drug)
结局指标
主要结局
Viral Suppression
时间窗: 48 Weeks
Percentage of patients with viral HIV load (VL) \<50 and \<200 copies/mL at 48 weeks
次要结局
- PK Assessment(Week 4 (+/- 14 days) with time points at predose (-0.5 hr), 0.5, 1, 2, 4, 6, 8, 12, and 24 hours)
- Adverse Events Assessment(Day 28, Weeks 12, 24, 36, & 48)
- Wellbeing Improvement(Week 48)
- Tolerability of Study Drug(Week 48)
- Work Productivity and Activity(Week 48)
- Change in Body Mass Index(Week 48)