2025-522519-40-00招募中3 期
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
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 10
- 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
- Phase 2: To evaluate the antiretroviral activity of ISL+ULO qw compared to BIC/FTC/TAF qd, as assessed by the percentage of participants with HIV-1 RNA <50 copies/mL at Week 24
- Phase 2: To evaluate the safety and tolerability of ISL+ULO qw compared to BIC/FTC/TAF qd, as assessed by review of accumulated safety data through Week 24
- Phase 3: To evaluate the antiretroviral activity of ISL/ULO qw compared to BIC/FTC/TAF qd, as assessed by the percentage of participants with HIV-1 RNA <50 copies/mL at Week 48
- Phase 3: To evaluate the safety and tolerability of ISL/ULO qw compared with BIC/FTC/TAF qd, as assessed by review of accumulated safety data through Week 48
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Is human immunodeficiency virus type 1 (HIV-1) positive with: - Phase 2: Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies/mL. - Phase 3: 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
islatravir
Experimental
Participants receiving islatravir
干预措施: islatravir (Drug)
ulonivirine
Experimental
Participants receiving ulonivirine
干预措施: ulonivirine (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
Phase 2: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24
Phase 2: Percentage of Participants Who Experience an Adverse Event (AE) at Week 24
Phase 2: Percentage of Participants Who Experience an Adverse Event (AE) at Week 24
Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 24
Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 24
Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
Phase 3: Percentage of Participants Who Experience an AE at Week 48
Phase 3: Percentage of Participants Who Experience an AE at Week 48
Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 48
Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 48
次要结局
- Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
- Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
- Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 24
- Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48
- Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96
- Phase 2: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 24
- Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 48
- Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 96
- Phase 2: Percentage of Participants Who Experience an AE
- Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE
- Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 24
- Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 48
- Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 96
- Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
- Phase 3: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48
- Phase 3: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96
- Phase 3: Mean Change From Baseline in CD4+ T-Cell Count at Week 48
- Phase 3: Mean Change From Baseline in CD4+ T-Cell Count at Week 96
- Phase 3: Percentage of Participants Who Experience an AE
- Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE
- Phase 3: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 48
- Phase 3: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 96
- Phase 3: Mean Change From Baseline in Body Weight at Week 48
- Phase 3: Mean Change From Baseline in Body Weight at Week 96
研究者
Randolph Matthews
Scientific
Merck Sharp & Dohme LLC
研究点 (10)
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