2024-514046-37-00招募中3 期
A Phase 3, Randomized, Double-Blind, Active-Controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir (B/F/TAF).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 13
- 主要终点
- The proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as determined by the United States (US) Food and Drug Administration (FDA)-defined snapshot algorithm [Time Frame: Week 48]
研究概览
简要总结
The primary objective is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing B/F/TAF in virologically suppressed people with HIV at 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
- 是
入选标准
- •Participants 18 years of age or older at screening and able to understand and give written informed consent.
- •HIV-1 RNA < 50 copies/mL for ≥ 6 months before screening, as documented by: • One HIV-1 RNA < 50 copies/mL immediately preceding the 24 week period prior to screening. • Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must be < 50 copies/mL. • During the 6 to 12 months period prior to screening, transient detectable viremia ≥ 50 copies/mL is acceptable (“blip”), as long as it is not confirmed on 2 consecutive visits.
- •Plasma HIV-1 RNA levels < 50 copies/mL at screening.
- •Individuals are receiving B/F/TAF for ≥ 6 months prior to screening and willing to continue until Day
- •Individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.
- •Note: Other protocol defined Inclusion criteria may apply.
排除标准
- •Note: Other protocol defined Exclusion criteria may apply.
- •Prior virologic failure.
- •Prior use of, or exposure to, ISL or LEN.
- •Active, serious infections requiring parenteral therapy within 30 days before randomization.
- •Active tuberculosis infection.
- •Acute hepatitis within 30 days before randomization.
- •Hepatitis B virus (HBV) infection, as determined below at the screening visit: • Positive HBV surface antigen. OR •Positive HBV core antibody and negative HBV surface antibody. Note: participants found to be susceptible to HBV infection (eg negative hepatitis B surface antibody at the screening visit, regardless of prior HBV vaccination history) should be recommended to receive HBV vaccination.
- •Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA. Note: participants with prior/inactive HCV infection (defined as undetectable HCV RNA) may be enrolled.
- •Any of the following laboratory values at screening: • Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula (Cockcroft 1976) • Alanine aminotransferase > 5 x upper limit of normal (ULN) • Direct bilirubin > 1.5 x ULN • Platelets < 50,000/μL • Hemoglobin < 8.0 g/dL
结局指标
主要结局
The proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as determined by the United States (US) Food and Drug Administration (FDA)-defined snapshot algorithm [Time Frame: Week 48]
The proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as determined by the United States (US) Food and Drug Administration (FDA)-defined snapshot algorithm [Time Frame: Week 48]
次要结局
- Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the US FDA-Defined Snapshot Algorithm [Time Frame: Week 96]
- Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Weeks 48 as Determined by the US FDA-Defined Snapshot Algorithm [Time Frame: Week 48]
- Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Weeks 96 as Determined by the US FDA-Defined Snapshot Algorithm [Time Frame: Week 96]
- Change From Baseline in Cluster of Differentiation 4 (CD4) T-Cell Count at Weeks 48 [Time Frame: Week 48]
- Change From Baseline in CD4 T-Cell Count at Weeks 96 [Time Frame: Week 96]
- Proportion of Participants Discontinuing ISL/LEN due to Treatment-Emergent Adverse Events (AEs) [Time Frame: Day 1 up to Week 48]
研究者
EU CT Support
Scientific
Gilead Sciences Inc.
研究点 (13)
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