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 Alafenamide (B/F/TAF)

Gilead Sciences K.K.0 个研究点目标入组 600 人开始时间: 2025年1月27日最近更新: 2025年5月27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 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.

•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 > 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

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发起方