A Phase 2b, Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Islatravir (ISL) and Ulonivirine (ULO) Once Weekly in Adults With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 23
- 主要终点
- Percentage of Participants With HIV-1 RNA ≥50 copies/mL at Week 24
研究概览
简要总结
Investigators are trying to find better treatments for people with HIV-1. In this clinical study, investigators want to see how well a new treatment called ISL+ULO, taken once a week, works compared to an existing treatment called BIC/FTC/TAF, which is taken every day. Investigators will check how many people still have a high level of the virus in their blood after 24 weeks. The investigators also want to understand if the new treatment, MK-8591B, is safe and how well people can handle it.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ISL + ULO in Group 1
In part 1 of the study, participants will receive ISL 2mg + ULO 200mg orally once a week (QW) for 48 weeks. In part 2 (2nd 48 weeks), participants will continue to receive ISL 2mg + ULO 200mg once a week till week 96.
干预措施: ISL (Drug)
ISL + ULO in Group 1
In part 1 of the study, participants will receive ISL 2mg + ULO 200mg orally once a week (QW) for 48 weeks. In part 2 (2nd 48 weeks), participants will continue to receive ISL 2mg + ULO 200mg once a week till week 96.
干预措施: ULO (Drug)
BIC/FTC/TAF in Group 2
In part 1 of the study, participants will receive BIC 50mg/FTC 200mg/TAF 25mg orally once daily (QD) for 48 weeks.
干预措施: BIC/FTC/TAF (Drug)
ISL + ULO in Group 2
In part 2 of the study, participants previously on BIC/FTC/TAF (for the 1st 48 weeks, or part 1) will switch to ISL + ULO, to week 96.
干预措施: ISL (Drug)
ISL + ULO in Group 2
In part 2 of the study, participants previously on BIC/FTC/TAF (for the 1st 48 weeks, or part 1) will switch to ISL + ULO, to week 96.
干预措施: ULO (Drug)
结局指标
主要结局
Percentage of Participants With HIV-1 RNA ≥50 copies/mL at Week 24
时间窗: Week 24
Plasma HIV-1 ribonucleic acid (RNA) quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay. Percentage of participants with HIV-1 RNA ≥50 copies/mL will be reported at week 24.
Percentage of Participants who Experience an Adverse Event (AE)
时间窗: Up to ~ 96 weeks
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who experience an AE will be reported.
Percentage of Participants Discontinuing Study Treatment due to AEs
时间窗: Up to ~ 96 weeks
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who discontinue study treatment due to an AE will be reported.
次要结局
- Percentage of Participants With HIV-1 RNA ≥50 copies/mL at Week 48(Week 48)
- Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 24(Week 24)
- Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 48(Week 48)
- Percentage of Participants With HIV-1 RNA <200 copies/mL at Week 24(Week 24)
- Percentage of Participants With HIV-1 RNA <200 copies/mL at Week 48(Week 48)
- Percentage of Participants With HIV-1 RNA ≥50 copies/mL at Week 96(Week 96)
- Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 96(Week 96)
- Percentage of Participants With HIV-1 RNA <200 copies/mL at Week 96(Week 96)
- Mean Change From Baseline in CD4+ T-cell Count at Week 24(Week 24)
- Mean Change From Baseline in CD4+ T-cell Count at Week 48(Week 48)
- Mean Change From Baseline in CD4+ T-cell Count at Week 96(Week 96)
- Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at Week 24(Week 24)
- Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at Week 48(Week 48)
- Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at Week 96(Week 96)