A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Standard of Care

Gilead Sciences K.K.0 个研究点目标入组 600 人开始时间: 2025年1月28日最近更新: 2025年5月30日

试验速览

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•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 weeks 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.
•Are receiving guideline-recommended standard of care treatment such as International Antiviral Society (IAS), Department of Health and Human Services (DHHS), European AIDS Clinical Society (EACS) consisting of 2 or 3 ARVs for >= 6 months prior to screening and willing to continue until Day
•Individuals in Treatment Group 2 must also be willing to continue their standard of care through at least Week
•Individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.

•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: individuals 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: individuals 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
•Alanine aminotransferase (ALT) > 5 x upper limit of normal (ULN)
•Direct bilirubin > 1.5 x ULN
•Platelets < 50,000/uL
•Hemoglobin < 8.0 g/dL

Proportion of participants with HIV-1 RNA >= 50 copies/mL at Week 48

时间窗: Week 48

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 96 as Determined by the US FDA-defined Snapshot Algorithm(Week 96)
Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 48 and Week96 as Determined by the US FDA-defined Snapshot Algorithm(Week 48, Week96)
Change from Baseline in clusters of differentiation 4 (CD4) T-Cell Count at Week 48 and Week96(Baseline, Week 48, Week96)
Proportion of Participants Discontinuing ISL/LEN due to Treatment-Emergent Adverse Events (TEAEs)(First dose date up to Week 96)

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