A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in HIV-1 Infected Treatment-Naïve Participants

Conditions

HIV-1 Infection

Brief summary

Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) ≥50 copies/mL at Week 48, Percentage of participants experiencing ≥1 adverse event (AE) through Week 48, Percentage of participants discontinuing from study treatment due to an AE through Week 48

Detailed description

Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96, Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48, Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96, Change from baseline in cluster of differentiation 4+ (CD4+) T-cells at Week 48, Change from baseline in CD4+ T-cells at Week 96, Incidence of viral drug resistance, Change from baseline in body weight at Week 48, Change from baseline in body weight at Week 96, Percentage of participants experiencing ≥1 AE through Week 96, Percentage of participants discontinuing from study treatment due to an AE through Week 48, Percentage of participants with HIV-1 RNA <50 copies/mL at Week 144, Percentage of participants with HIV-1 RNA <200 copies/mL at Week 144., Change from baseline in CD4+ T-cells at Week 144., Change from baseline in body weight at Week 144

Related papers

No related papers found yet.

Interventions

DRUGMK-8591A

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

DRUGPlacebo to bictegravir/ emtricitabine/ tenofovir alafenamide

DRUGPlacebo to doravirine/ islatravir

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) ≥50 copies/mL at Week 48, Percentage of participants experiencing ≥1 adverse event (AE) through Week 48, Percentage of participants discontinuing from study treatment due to an AE through Week 48	—

Secondary

Measure	Time frame
Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96, Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48, Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96, Change from baseline in cluster of differentiation 4+ (CD4+) T-cells at Week 48, Change from baseline in CD4+ T-cells at Week 96, Incidence of viral drug resistance, Change from baseline in body weight at Week 48, Change from baseline in body weight at Week 96, Percentage of participants experiencing ≥1 AE through Week 96, Percentage of participants discontinuing from study treatment due to an AE through Week 48, Percentage of participants with HIV-1 RNA <50 copies/mL at Week 144, Percentage of participants with HIV-1 RNA <200 copies/mL at Week 144., Change from baseline in CD4+ T-cells at Week 144., Change from baseline in body weight at Week 144	—

Measure

Time frame

Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96, Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48, Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96, Change from baseline in cluster of differentiation 4+ (CD4+) T-cells at Week 48, Change from baseline in CD4+ T-cells at Week 96, Incidence of viral drug resistance, Change from baseline in body weight at Week 48, Change from baseline in body weight at Week 96, Percentage of participants experiencing ≥1 AE through Week 96, Percentage of participants discontinuing from study treatment due to an AE through Week 48, Percentage of participants with HIV-1 RNA <50 copies/mL at Week 144, Percentage of participants with HIV-1 RNA <200 copies/mL at Week 144., Change from baseline in CD4+ T-cells at Week 144., Change from baseline in body weight at Week 144

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Countries

France, Germany, Spain

Outcome results

None listed