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A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502079-49-00
Acronym
MK-8591A-052
Enrollment
180
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 human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) ≥50 copies/mL at Week 48, Percentage of participants who experience adverse events (AEs) through Week 48, Percentage of participants who discontinue study intervention due to AEs 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 <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, Change from baseline in CD4+ T-cell count at Week 48, Change from baseline in CD4+ T-cell count at Week 96, Number of participants with viral drug resistance mutations at Week 48, Number of participants with viral drug resistance mutations at Week 96, Percentage of participants who experience AEs through study duration, Percentage of participants who discontinue study intervention due to AEs through study duration

Interventions

DRUGBiktarvy 50 mg/200 mg/25 mg film-coated tablets
DRUGPlacebo to MK-8591A tablets
DRUGPlacebo to Biktarvy

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage of participants with human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) ≥50 copies/mL at Week 48, Percentage of participants who experience adverse events (AEs) through Week 48, Percentage of participants who discontinue study intervention due to AEs through Week 48—

Secondary

MeasureTime 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 <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, Change from baseline in CD4+ T-cell count at Week 48, Change from baseline in CD4+ T-cell count at Week 96, Number of participants with viral drug resistance mutations at Week 48, Number of participants with viral drug resistance mutations at Week 96, Percentage of participants who experience AEs through study duration, Percentage of participants who discontinue study intervention due to AEs through study duration—

Countries

France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026