An Operationally Seamless Phase 2/3, Randomized, Active -Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination With GS-4182 Versus Biktarvy in Virologically Suppressed People With HIV-1

HIV-1 Infection

Phase 2: The proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24 as determined by the United States (US) Food and Drug Administration (FDA)-defined snapshot algorithm, Phase 3: The proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as determined by the US FDA-defined snapshot algorithm

Phase 2: The proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Weeks 12 and 48 as determined by the US FDA-defined snapshot algorithm, Phase 2: The proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 12, 24, and 48 as determined by the US FDA-defined snapshot algorithm, Phase 2: The change from baseline in CD4+ T-cell count at Weeks 12, 24, and 48, Phase 2: The proportion of participants experiencing treatment-emergent adverse events (TEAEs), and treatment-emergent laboratory abnormalities through Weeks 12, 24, and 48, Phase 2: PK parameters (Cmax, Tmax, Ctau, and AUCtau, as applicable) of GS-1720 and lenacapavir (LEN), Phase 3: The proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 as determined by the US FDA-defined snapshot algorithm, Phase 3: The proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 48 and 96 as determined by the US FDA-defined snapshot algorithm, Phase 3: The change from baseline in CD4+ T-cell count at Weeks 48 and 96, Phase 3: The proportion of participants experiencing TEAEs, and treatment-emergent laboratory abnormalities through Weeks 48 and 96

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