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)

Phase 2Active Not RecruitingNCT06891066

Merck Sharp & Dohme LLC150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (23)

Zuckerberg San Francisco General Hospital and Trauma Center ( Site 4107)

San Francisco, California, United States

Mills Clinical Research ( Site 4109)

West Hollywood, California, United States

Georgetown University Medical Center ( Site 4106)

Washington D.C., District of Columbia, United States

Orlando Immunology Center ( Site 4103)

Orlando, Florida, United States

Triple O Research Institute ( Site 4111)

West Palm Beach, Florida, United States

Outcomes

Primary Outcomes

Percentage of Participants With HIV-1 RNA ≥50 copies/mL at Week 24

Plasma HIV-1 ribonucleic acid (RNA) quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay. Percentage of participants with HIV-1 RNA ≥50 copies/mL will be reported at week 24.

Time frame: Week 24

Percentage of Participants who Experience an Adverse Event (AE)

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who experience an AE will be reported.

Time frame: Up to ~ 96 weeks

Percentage of Participants Discontinuing Study Treatment due to AEs

Time frame: Up to ~ 96 weeks

Secondary Outcomes

Percentage of Participants With HIV-1 RNA ≥50 copies/mL at Week 48

Plasma HIV-1 RNA quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay. Percentage of participants with HIV-1 RNA ≥50 copies/mL will be reported at week 48.

Time frame: Week 48

Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 24

Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<50 copies/mL will be reported at week 24.

Time frame: Week 24

Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 48

Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<50 copies/mL will be reported at week 48.

Time frame: Week 48

Percentage of Participants With HIV-1 RNA <200 copies/mL at Week 24

Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<200 copies/mL will be reported at week 24.

Time frame: Week 24

Percentage of Participants With HIV-1 RNA <200 copies/mL at Week 48

Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<200 copies/mL will be reported at week 48.

Time frame: Week 48

Percentage of Participants With HIV-1 RNA ≥50 copies/mL at Week 96

Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA ≥50 copies/mL will be reported at week 96.

Time frame: Week 96

Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 96

Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<50 copies/mL will be reported at week 96.

Time frame: Week 96

Percentage of Participants With HIV-1 RNA <200 copies/mL at Week 96

Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<200 copies/mL will be reported at week 96.

Time frame: Week 96

Mean Change From Baseline in CD4+ T-cell Count at Week 24

The mean change from baseline in CD4+ T-cell count will be calculated at each applicable time point at which CD4+ T-cell count is collected with primary interest at 24 weeks. Blood samples are taken for this purpose. Baseline measurements are defined as the Day 1 value for each participant.

Time frame: Week 24

Mean Change From Baseline in CD4+ T-cell Count at Week 48

The mean change from baseline in CD4+ T-cell count will be calculated at each applicable time point at which CD4+ T-cell count is collected with primary interest at 48 weeks. Blood samples are taken for this purpose. Baseline measurements are defined as the Day 1 value for each participant.

Time frame: Week 48

Mean Change From Baseline in CD4+ T-cell Count at Week 96

The mean change from baseline in CD4+ T-cell count will be calculated at each applicable time point at which CD4+ T-cell count is collected with primary interest at 96 weeks. Blood samples are taken for this purpose. Baseline measurements are defined as the Day 1 value for each participant.

Time frame: Week 96

Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at Week 24

Antiviral drug resistance is the reduced susceptibility of the virus to the study intervention. Participants with HIV-1 RNA ≥400 copies/mL will be included in the resistance analyses. Participants who have test results showing signs of viral resistance will also be included for analysis, irrespective of the viral load. Percentage of participants in each treatment group who have evidence of resistance-associated substitutions will be analyzed at week 24.

Time frame: Week 24

Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at Week 48

Time frame: Week 48

Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at Week 96

Time frame: Week 96