A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in HIV-1 Infected Treatment-Naïve Participants
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 537
- 试验地点
- 131
- 主要终点
- Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL at Week 48
研究概览
简要总结
This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL [MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL at screening
- •Is naïve to antiretroviral therapy (ART) defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection
- •If female, is not a participant of childbearing potential (POCBP); or if a POCBP, is not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration
排除标准
- •Has HIV-2 infection
- •Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
- •Has a diagnosis of an active AIDS-defining opportunistic infection within 30 days prior to screening
- •Has active hepatitis B infection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA]-positive).
- •Has chronic hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid [RNA]) and lab values are consistent with cirrhosis
- •Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
- •Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality, or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate
研究组 & 干预措施
DOR/ISL
Participants take DOR/ISL and placebo to BIC/FTC/TAF once daily (qd) for 144 weeks.
干预措施: DOR/ISL (Drug)
DOR/ISL
Participants take DOR/ISL and placebo to BIC/FTC/TAF once daily (qd) for 144 weeks.
干预措施: Placebo to BIC/FTC/TAF (Drug)
BIC/FTC/TAF
Participants take BIC/FTC/TAF and placebo to DOR/ISL qd for 144 weeks.
干预措施: BIC/FTC/TAF (Drug)
BIC/FTC/TAF
Participants take BIC/FTC/TAF and placebo to DOR/ISL qd for 144 weeks.
干预措施: Placebo to DOR/ISL (Drug)
结局指标
主要结局
Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL at Week 48
时间窗: Week 48
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay with a lower limit of detection of \<50 copies/mL.
Percentage of participants experiencing ≥1 adverse event (AE) through Week 48
时间窗: Up to 48 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Percentage of participants discontinuing from study treatment due to an AE through Week 48
时间窗: Up to 48 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
次要结局
- Percentage of participants with HIV-1 RNA <50 copies/mL at Week 144(Week 144)
- 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 <200 copies/mL at Week 96(Week 96)
- Percentage of participants with HIV-1 RNA <200 copies/mL at Week 144(Week 144)
- Change from baseline in cluster of differentiation 4+ (CD4+) T-cells at Week 48(Baseline (Day 1) and Week 48)
- Change from baseline in CD4+ T-cells at Week 96(Baseline (Day 1) and Week 96)
- Change from baseline in CD4+ T-cells at Week 144(Baseline (Day 1) and Week 144)
- Incidence of viral drug resistance(Up to 96 weeks)
- Change from baseline in body weight at Week 48(Baseline (Day 1) and Week 48)
- Change from baseline in body weight at Week 96(Baseline (Day 1) and Week 96)
- Change from baseline in body weight at Week 144(Baseline (Day 1) and Week 144)
- Percentage of participants experiencing ≥1 AE through Week 144(Up to 144 weeks)
- Percentage of participants discontinuing from study treatment due to an AE through Week 144(Up to 144 weeks)