A Phase 3, Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Antiretroviral Therapy

Conditions

HIV-1 Infection

Brief summary

Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48, Percentage of participants with one or more adverse events (AEs) from Day 1 up to Week 48, Percentage of participants with an AE leading to discontinuation of study intervention from Day 1 up to Week 48

Detailed description

Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48, Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48, Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96, Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96, Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96, Mean change from baseline at Day 1 in CD4+ T-cell count at Week 48, Mean change from baseline at Week 48 in CD4+ T-cell count at Week 96, Mean change from baseline at Day 1 in CD4+ T-cell count at Week 96, Number of participants with viral resistance-associated substitutions, Mean change from baseline to Week 48 in fasting LDL-C, Mean change from baseline to Week 48 in fasting HDL-C, Percentage of participants with one or more AEs from Day 1 up to Week 96, Percentage of participants with an AE leading to discontinuation of study intervention from Day 1 up to Week 96, Percentage of participants with one or more AEs from Week 48 up to Week 96, Percentage of participants with an AE leading to discontinuation of study intervention from Week 48 up to Week 96

Related papers

No related papers found yet.

Interventions

DRUGTybost 150 mg film-coated tablets

DRUG-

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48, Percentage of participants with one or more adverse events (AEs) from Day 1 up to Week 48, Percentage of participants with an AE leading to discontinuation of study intervention from Day 1 up to Week 48	—

Secondary

Measure	Time frame
Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48, Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48, Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96, Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96, Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96, Mean change from baseline at Day 1 in CD4+ T-cell count at Week 48, Mean change from baseline at Week 48 in CD4+ T-cell count at Week 96, Mean change from baseline at Day 1 in CD4+ T-cell count at Week 96, Number of participants with viral resistance-associated substitutions, Mean change from baseline to Week 48 in fasting LDL-C, Mean change from baseline to Week 48 in fasting HDL-C, Percentage of participants with one or more AEs from Day 1 up to Week 96, Percentage of participants with an AE leading to discontinuation of study intervention from Day 1 up to Week 96, Percentage of participants with one or more AEs from Week 48 up to Week 96, Percenta	—

Measure

Time frame

Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48, Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48, Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96, Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96, Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96, Mean change from baseline at Day 1 in CD4+ T-cell count at Week 48, Mean change from baseline at Week 48 in CD4+ T-cell count at Week 96, Mean change from baseline at Day 1 in CD4+ T-cell count at Week 96, Number of participants with viral resistance-associated substitutions, Mean change from baseline to Week 48 in fasting LDL-C, Mean change from baseline to Week 48 in fasting HDL-C, Percentage of participants with one or more AEs from Day 1 up to Week 96, Percentage of participants with an AE leading to discontinuation of study intervention from Day 1 up to Week 96, Percentage of participants with one or more AEs from Week 48 up to Week 96, Percenta

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Countries

France, Italy, Spain

Outcome results

None listed