A Phase 2/3, Randomized, Active-Controlled, Open-Label (Phase 2) and Double-Blind (Phase 3) Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily in Treatment-Naïve Adult Participants Living With HIV-1
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 570
- 试验地点
- 55
- 主要终点
- Phase 2: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24
研究概览
简要总结
Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers want to know if a study ART works as well as a standard ART to treat HIV-1. The study ART combines 2 medicines, islatravir and ulonivirine, and is taken once a week. The goals of this study are to learn: 1) If the study ART works as well as a standard ART to treat HIV-1, and 2) About the safety of the study ART and if people tolerate it compared to a standard ART.
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)
盲法说明
Phase 2: no masking Phase 3: Participant, Sponsor, and Investigator are masked
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
- •Phase 2: Is human immunodeficiency virus type 1 (HIV-1) positive with Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies/mL.
- •Phase 3: Is HIV-1 positive with Plasma HIV-1 RNA ≥500 copies/mL.
- •Phase 2: Has cluster of differentiation 4-positive (CD4+) T-cell count ≥200 cells/mm^
- •Is naïve to antiretroviral therapy (ART), defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection.
排除标准
- •Has human immunodeficiency virus type 2 (HIV-2) infection.
- •Has a diagnosis of an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection.
- •Has active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection.
- •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 or in situ anal cancer, or cutaneous Kaposi's sarcoma.
- •Has prior exposure to islatravir (ISL) or ulonivirine (ULO) for any duration any time prior to Day 1.
研究组 & 干预措施
Phase 3: ISL/ULO and Placebo to BIC/FTC/TAF
ISL/ULO fixed dose combination (2/200 mg), administered orally qw, and matching placebo to BIC/FTC/TAF administered orally qd for 96 weeks
干预措施: Placebo for BIC/FTC/TAF (Drug)
Phase 2: ISL + ULO
Islatravir (ISL) 2mg and Ulonivirine (ULO) 200mg administered orally once weekly (qw) for 96 weeks
干预措施: ULO (Drug)
Phase 3: ISL/ULO and Placebo to BIC/FTC/TAF
ISL/ULO fixed dose combination (2/200 mg), administered orally qw, and matching placebo to BIC/FTC/TAF administered orally qd for 96 weeks
干预措施: ISL/ULO (Drug)
Phase 2: BIC/FTC/TAF
Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) 50/200/25 mg, administered orally once daily (qd) for 96 weeks
干预措施: BIC/FTC/TAF (Drug)
Phase 2: ISL + ULO
Islatravir (ISL) 2mg and Ulonivirine (ULO) 200mg administered orally once weekly (qw) for 96 weeks
干预措施: ISL (Drug)
Phase 3: BIC/FTC/TAF and Placebo to ISL/ULO
BIC/FTC/TAF 50/200/25 mg, administered orally qd, and matching placebo to ISL/ULO administered orally qw for 96 weeks
干预措施: Placebo to ISL/ULO (Drug)
Phase 3: BIC/FTC/TAF and Placebo to ISL/ULO
BIC/FTC/TAF 50/200/25 mg, administered orally qd, and matching placebo to ISL/ULO administered orally qw for 96 weeks
干预措施: BIC/FTC/TAF (Drug)
结局指标
主要结局
Phase 2: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (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.
Phase 2: Percentage of Participants Who Experience an Adverse Event (AE) at Week 24
时间窗: Week 24
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 24
时间窗: Week 24
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Phase 3: Percentage of Participants With HIV-1 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 PCR assay. Percentage of participants with HIV-1 RNA \<50 copies/mL will be reported at week 48.
Phase 3: Percentage of Participants Who Experience an AE at Week 48
时间窗: Week 48
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 48
时间窗: Week 48
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
次要结局
- Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48(Week 48)
- Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96(Week 96)
- Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 24(Week 24)
- Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48(Week 48)
- Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96(Week 96)
- Phase 2: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 24(Baseline (Day 1) and Week 24)
- Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 48(Baseline (Day 1) and Week 48)
- Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 96(Baseline (Day 1) and Week 96)
- Phase 2: Percentage of Participants Who Experience an AE(Up to approximately 102 weeks)
- Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE(Up to approximately 96 weeks)
- Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 24(Week 24)
- Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 48(Week 48)
- Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 96(Week 96)
- Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96(Week 96)
- Phase 3: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48(Week 48)
- Phase 3: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96(Week 96)
- Phase 3: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 48(Baseline (Day 1) and Week 48)
- Phase 3: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 96(Baseline (Day 1) and Week 96)
- Phase 3: Percentage of Participants Who Experience an AE(Up to approximately 102 weeks)
- Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE(Up to approximately 96 weeks)
- Phase 3: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 48(Week 48)
- Phase 3: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 96(Week 96)
- Phase 3: Mean Change From Baseline in Body Weight at Week 48(Baseline (Day 1) and Week 48)
- Phase 3: Mean Change From Baseline in Body Weight at Week 96(Baseline (Day 1) and Week 96)