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)

Purpose

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.

Condition

  • Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ISL + ULO in Group 1 		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.
  • Drug: ISL
    ISL 1mg oral capsule will be administered as 2mg orally (each capsule 1mg) as part of ISL and ULO combination to group 1 participants for 96 weeks and for group 2 participants in part 2 of the study from 49 to 96 weeks.
    Other names:
    • MK-8591
    • Islatravir
  • Drug: ULO
    ULO 100mg oral tablet will be administered as 200mg (2 tablets) orally as part of ISL and ULO combination to group 1 participants for 96 weeks and for group 2 participants in part 2 of the study from 49 to 96 weeks.
    Other names:
    • MK-8507
    • Ulonivirine.
Active Comparator
BIC/FTC/TAF in Group 2 		In part 1 of the study, participants will receive BIC 50mg/FTC 200mg/TAF 25mg orally once daily (QD) for 48 weeks.
  • Drug: BIC/FTC/TAF
    BIC 50mg oral tablet/FTC 200mg oral tablet/TAF 25 mg oral tablet administered orally to group 2 participants for 48 weeks in part 1 of the study.
    Other names:
    • BIKTARVY®
Experimental
ISL + ULO in Group 2 		In part 2 of the study, participants previously on BIC/FTC/TAF (for the 1st 48 weeks, or part 1) will switch to ISL + ULO, to week 96.
  • Drug: ISL
    ISL 1mg oral capsule will be administered as 2mg orally (each capsule 1mg) as part of ISL and ULO combination to group 1 participants for 96 weeks and for group 2 participants in part 2 of the study from 49 to 96 weeks.
    Other names:
    • MK-8591
    • Islatravir
  • Drug: ULO
    ULO 100mg oral tablet will be administered as 200mg (2 tablets) orally as part of ISL and ULO combination to group 1 participants for 96 weeks and for group 2 participants in part 2 of the study from 49 to 96 weeks.
    Other names:
    • MK-8507
    • Ulonivirine.

Recruiting Locations

Georgetown University Medical Center ( Site 4106)
Washington, District of Columbia 20007
Contact:
Study Coordinator
202-444-8525

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com