A Phase 2b, Randomized, Active-Controlled, Double-Blind, Dose-Ranging Clinical Study to Evaluate a Switch to Islatravir (ISL) and MK-8507 Once-Weekly in Adults with HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once-Daily

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511041-19-00

Acronym

MK-8591-013

Enrollment

Registered

2024-04-17

Start date

2021-04-06

Completion date

2025-01-28

Last updated

2025-01-29

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 ≥1 adverse event (AE), Percentage of participants discontinuing study intervention due to AE

Detailed description

Interventions

DRUGPlacebo to ISL

DRUGPlacebo to MK-8507

DRUGPlacebo to BIC/FTC/TAF

DRUGEMTRICITABINE

DRUGTENOFOVIR ALAFENAMIDE AND BICTEGRAVIR

DRUGislatravir

DRUGulonivirine

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of participants with ≥1 adverse event (AE), Percentage of participants discontinuing study intervention due to AE	—

Secondary

Measure	Time frame
NA	—

Countries

France

Outcome results

None listed

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