A Study of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly (QW) in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8591B-060)

Merck Sharp & Dohme (MSD)

Status and phase

Active, not recruiting

Phase 2

Conditions

Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Treatments

Drug: BIC/FTC/TAF

Drug: ULO

Drug: ISL

Study type

Interventional

Funder types

Industry

Identifiers

NCT06891066

MK-8591B-060 (Other Identifier)

8591B-060

Details and patient eligibility

About

Investigators are trying to find better treatments for people with HIV-1. In this clinical study, investigators want to see how well a new treatment called ISL+ULO, taken once a week, works compared to an existing treatment called BIC/FTC/TAF, which is taken every day. Investigators will check how many people still have a high level of the virus in their blood after 24 weeks. The investigators also want to understand if the new treatment, MK-8591B, is safe and how well people can handle it.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

The main inclusion criteria include but are not limited to the following:

- Has been receiving Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) therapy with documented viral suppression [Human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL] for ≥6 months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen.

Exclusion:

The main exclusion criteria include but are not limited to the following:

Has Human immunodeficiency virus type 2 (HIV-2) infection.
Has a diagnosis of an active Acquired immune deficiency syndrome (AIDS)-defining opportunistic infection.
Has active hepatitis C virus (HCV) coinfection.
Has hepatitis B virus (HBV) coinfection.
Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or in situ anal cancer, or cutaneous Kaposi's sarcoma.
Has prior exposure to Islatravir (ISL) or Ulonivirine (ULO) for any duration any time prior to Day 1.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 3 patient groups

ISL + ULO in Group 1

Experimental group

Description:

In part 1 of the study, participants will receive ISL 2mg + ULO 200mg orally once a week (QW) for 48 weeks. In part 2 (2nd 48 weeks), participants will continue to receive ISL 2mg + ULO 200mg once a week till week 96.

Treatment:

Drug: ULO

Drug: ISL

BIC/FTC/TAF in Group 2

Active Comparator group

Description:

In part 1 of the study, participants will receive BIC 50mg/FTC 200mg/TAF 25mg orally once daily (QD) for 48 weeks.

Treatment:

Drug: BIC/FTC/TAF

ISL + ULO in Group 2

Experimental group

Description: