2023-510022-33-00招募中3 期
Phase 3 Double-Blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy® (Bictegravir/ Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People with HIV-1
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 26
- 主要终点
- 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.
研究概览
简要总结
To evaluate the efficacy of switching to bictegravir/lenacapavir (BIC/LEN) (75/50 mg) fixed-dose combination (FDC) tablets versus continuing on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) FDC tablets in virologically suppressed people with HIV-1
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 18 years at screening.
- •Currently receiving B/F/TAF for at least 6 months prior to screening.
- •If plasma HIV-1 RNA measurements in the last 6 months prior to screening are available, all levels must be < 50 copies/mL.
- •At least one documented HIV-1 RNA level measured between 6 and 12 months (± 2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be < 50 copies/mL.
- •Plasma HIV-1 RNA levels < 50 copies/mL at screening.
- •No documented or suspected resistance to BIC (mutations T66A/I/K, E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene).
- •No documented or suspected resistance to tenofovir alafenamide (TAF; mutations K65R, K65N, K70E, Q151M or T69 insertion, or ≥ 3 of the following thymidine analog mutations [M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R] in the reverse transcriptase gene).
- •Estimated glomerular filtration rate > 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance (CLcr).
- •Participants assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.
排除标准
- •Positive serum pregnancy test or pregnant at screening or a positive pregnancy test prior to Day 1 randomization.
- •Active, serious infections (other than HIV-1) requiring parenteral therapy < 30 days prior to randomization.
- •Active tuberculosis infection.
- •Acute hepatitis < 30 days before randomization.
- •Chronic hepatitis B virus (HBV) infection, as determined by either: a) Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit. b) Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit.
- •Known hypersensitivity to the study drug, its metabolites, or any formulation excipient.
- •History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
- •Participants under guardianship, curatorship, or legal protection may not participate in the study.
- •Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator.
- •Active malignancy requiring acute systemic therapy.
- •Any of the following laboratory values at screening: a) Alanine aminotransferase > 5 × upper limit of normal (ULN) b) Direct bilirubin > 1.5 × ULN c) Platelets < 50,000/mm3 d) Hemoglobin < 8.0 g/dL
- •Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section 5.3 of the protocol.
- •Participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor.
- •Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements
- •Breastfeeding (nursing).
- •Prior use of, or exposure to, LEN.
结局指标
主要结局
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.
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.
次要结局
- Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 48 as determined by the US FDA-defined snapshot algorithm
- Change from baseline in CD4 cell count at Week 48
- Proportion of participants from Treatment Group 1 with HIV-1 RNA ≥ 50 copies/mL at Week 96 (96 weeks on BIC/LEN including blinded and open-label [OL] phases) as determined by US FDA–defined snapshot algorithm
- Proportion of participants from Treatment Group 1 with HIV-1 RNA < 50 copies/mL at Week 96 (96 weeks on BIC/LEN including blinded and OL phases) as determined by US FDA–defined snapshot algorithm
- Change from baseline in CD4 cell count at Week 96 for participants from Treatment Group 1 (96 weeks on BIC/LEN including blinded and OL phases)
- Proportion of participants experiencing treatment-emergent adverse events (AEs) through Week 48
- Proportion of participants from Treatment Group 1 experiencing treatment-emergent AEs through Week 96 (96 weeks on BIC/LEN including blinded and OL phases)
研究者
EU CT Support
Scientific
Gilead Sciences Inc.
研究点 (26)
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