A Phase 3 Open-label Rollover Clinical Study of Doravirine/Islatravir (DOR/ISL) Once-daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL in a Phase 2 or Phase 3 DOR/ISL Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
- 试验地点
- 93
- 主要终点
- Participants who discontinued due to an adverse event (AE)
研究概览
简要总结
The safety and tolerability of MK-8591A, a 2-drug fixed dose combination (FDC) of doravirine (100mg) and islatravir (0.75mg) [DOR/ISL 100 mg/0.75 mg) will be evaluated in participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.
详细描述
As of Amendment 12, participants will have the option to continue receiving DOR/ISL (100 mg/0.75 mg) until treatment alternatives are identified, or up to Week 288 given that participants are still deriving benefit, based on individual benefit/risk assessment.
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
- •Is currently receiving DOR 100 mg/ISL 0.75 mg adult FDC tablet in an MSD-sponsored clinical study and has completed the last treatment visit.
- •Is considered by the investigator to have derived clinical benefit from receiving DOR/ISL and for whom further treatment with DOR/ISL is considered clinically appropriate.
- •Female is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); or is a non-pregnant WOCBP who agrees to the following during the intervention period and for at least 6 weeks after the last dose of study intervention: Not be sexually active, or if sexually active, to use an acceptable method of contraception; or is pregnant and continues to receive study intervention (where allowed by local regulations and as appropriate based on available data/local standard-of-care guidelines)
排除标准
- •Is taking or is anticipated to require any prohibited therapies.
研究组 & 干预措施
MK-8591A
Fixed dose combination (FDC) tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks.
干预措施: MK-8591A (Drug)
结局指标
主要结局
Participants who discontinued due to an adverse event (AE)
时间窗: Up to Week 192
Percentage of participants who discontinued study treatment due to an AE.
Participants with serious adverse events (SAEs)
时间窗: Up to Week 198
Percentage of participants with serious adverse events (SAEs)
次要结局
未报告次要终点