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 Treatment Naive People with HIV-1

Conditions

HIV-1 Infection

Brief summary

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

Detailed description

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, The change from baseline in log10 HIV-1 RNA and CD4 cell count at Weeks 12, 24, and 48, The proportion of participants experiencing treatment-emergent adverse events (TEAEs), and treatment-emergent laboratory abnormalities through Weeks 12, 24, and 48, 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, The change from baseline in log10 HIV-1 RNA and CD4 cell count at Weeks 48 and 96, The proportion of participants experiencing TEAEs, and treatment-emergent laboratory abnormalities through Weeks 48 and 96

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGGS-4182

DRUGBiktarvy 50 mg/200 mg/25 mg film-coated tablets

DRUGGS-1720

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
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, The change from baseline in log10 HIV-1 RNA and CD4 cell count at Weeks 12, 24, and 48, The proportion of participants experiencing treatment-emergent adverse events (TEAEs), and treatment-emergent laboratory abnormalities through Weeks 12, 24, and 48, 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, The change from baseline in log10 HIV-1 RNA and CD4 cell count at Weeks 48 and 96, The proportion of participants experiencing TEAEs, and treatment-emergent laboratory abnormalities through Weeks 48 and 96	—

Measure

Time frame

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, The change from baseline in log10 HIV-1 RNA and CD4 cell count at Weeks 12, 24, and 48, The proportion of participants experiencing treatment-emergent adverse events (TEAEs), and treatment-emergent laboratory abnormalities through Weeks 12, 24, and 48, 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, The change from baseline in log10 HIV-1 RNA and CD4 cell count at Weeks 48 and 96, The proportion of participants experiencing TEAEs, and treatment-emergent laboratory abnormalities through Weeks 48 and 96

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Countries

Germany, Poland, Portugal, Romania, Spain

Outcome results

None listed