A Phase 3 Open-label Clinical Study of Doravirine/Islatravir (DOR/ISL [100 mg/0.25 mg]) Once Daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL (100 mg/0.75 mg) QD in a Phase 3 Clinical Study

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502126-40-00

Acronym

MK-8591A-054

Enrollment

356

Registered

2023-04-28

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 infection

Brief summary

Percentage of participants with one or more adverse events, Percentage of participants who discontinue study intervention due to adverse events

Detailed description

Percentage of participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 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 ≥200 copies/mL at Week 96, Percentage of participants with evidence of viral drug resistance-associated substitutions

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of participants with one or more adverse events, Percentage of participants who discontinue study intervention due to adverse events	—

Secondary

Measure	Time frame
Percentage of participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 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 ≥200 copies/mL at Week 96, Percentage of participants with evidence of viral drug resistance-associated substitutions	—

Countries

Finland, France, Germany, Italy, Poland, Spain

Outcome results