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

Conditions

HIV-1 Infection

Brief summary

The 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 [Time Frame: Week 48]

Detailed description

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

Related papers

No related papers found yet.

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

Interventions

DRUGRITONAVIR

DRUGEMTRICITABINE AND TENOFOVIR ALAFENAMIDE

DRUGRILPIVIRINE

DRUGISLATRAVIR/LENACAPAVIR

DRUGEMTRICITABINE

DRUGTENOFOVIR DISOPROXIL AND RILPIVIRINE

DRUGTENOFOVIR DISOPROXIL

DRUGELVITEGRAVIR AND COBICISTAT

DRUGTENOFOVIR ALAFENAMIDE

DRUGDORAVIRINE

DRUGDOLUTEGRAVIR

DRUGDARUNAVIR AND COBICISTAT

DRUGLAMIVUDINE AND DOLUTEGRAVIR

DRUGRALTEGRAVIR

DRUGTENOFOVIR ALAFENAMIDE AND BICTEGRAVIR

DRUGDARUNAVIR

DRUGLAMIVUDINE

DRUGABACAVIR AND DOLUTEGRAVIR

DRUGTENOFOVIR ALAFENAMIDE AND RILPIVIRINE

DRUGTENOFOVIR DISOPROXIL AND DORAVIRINE

DRUGCOBICISTAT

DRUGTENOFOVIR DISOPROXIL AND EMTRICITABINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The 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 [Time Frame: Week 48]	—

Secondary

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

Measure

Time frame

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

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Countries

Germany, Netherlands, Poland, Spain

Outcome results

None listed