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)
- Conditions
- Human Immunodeficiency Virus Type 1 (HIV-1) Infection
- Interventions
- Registration Number
- NCT06891066
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ISL + ULO in Group 1 ISL 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. ISL + ULO in Group 1 ULO 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. BIC/FTC/TAF in Group 2 BIC/FTC/TAF In part 1 of the study, participants will receive BIC 50mg/FTC 200mg/TAF 25mg orally once daily (QD) for 48 weeks. ISL + ULO in Group 2 ISL 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. ISL + ULO in Group 2 ULO 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With HIV-1 RNA ≥50 copies/mL at Week 24 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.
Percentage of Participants who Experience an Adverse Event (AE) Up to ~ 96 weeks 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.
Percentage of Participants Discontinuing Study Treatment due to AEs Up to ~ 96 weeks 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 discontinue study treatment due to an AE will be reported.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With HIV-1 RNA ≥50 copies/mL at Week 48 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.
Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 24 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.
Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 48 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.
Percentage of Participants With HIV-1 RNA <200 copies/mL at Week 24 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.
Percentage of Participants With HIV-1 RNA <200 copies/mL at Week 48 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.
Percentage of Participants With HIV-1 RNA ≥50 copies/mL at Week 96 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.
Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 96 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.
Percentage of Participants With HIV-1 RNA <200 copies/mL at Week 96 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.
Mean Change From Baseline in CD4+ T-cell Count at Week 24 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.
Mean Change From Baseline in CD4+ T-cell Count at Week 48 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.
Mean Change From Baseline in CD4+ T-cell Count at Week 96 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.
Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at Week 24 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.
Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at Week 48 Week 48 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 48.
Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at Week 96 Week 96 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 96.
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Trial Locations
- Locations (21)
Georgetown University Medical Center ( Site 4106)
🇺🇸Washington, District of Columbia, United States
Ponce Medical School Foundation Inc./CAIMED Center ( Site 4301)
🇵🇷Ponce, Puerto Rico
Clinical Research Puerto Rico ( Site 4300)
🇵🇷San Juan, Puerto Rico
Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 4404)
🇨🇭Genève, Geneve, Switzerland
Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 4405)
🇨🇭Lugano, Ticino, Switzerland
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
Orlando Immunology Center ( Site 4103)
🇺🇸Orlando, Florida, United States
Triple O Research Institute ( Site 4111)
🇺🇸West Palm Beach, Florida, United States
Chatham County Health Department - Chatham CARE Center ( Site 4116)
🇺🇸Savannah, Georgia, United States
KC CARE Health Center ( Site 4101)
🇺🇸Kansas City, Missouri, United States
Regional Center for Infectious Diseases ( Site 4115)
🇺🇸Greensboro, North Carolina, United States
Central Texas Clinical Research ( Site 4100)
🇺🇸Austin, Texas, United States
Prism Health North Texas, Oak Cliff Health Center ( Site 4114)
🇺🇸Dallas, Texas, United States
DCOL Center for Clinical Research ( Site 4112)
🇺🇸Longview, Texas, United States
Momentum Clinical Research - Darlinghurst ( Site 4260)
🇦🇺Darlinghurst, New South Wales, Australia
Momentum Clinical Research Fortitude Valley ( Site 4261)
🇦🇺Fortitude Valley, Queensland, Australia
Prahran Market Clinic ( Site 4262)
🇦🇺Prahran, Victoria, Australia
HOPE Clinical Research ( Site 4303)
🇵🇷San Juan, Puerto Rico
University Hospital Basel-Infectiology ( Site 4402)
🇨🇭Basel, Basel-Stadt, Switzerland
Inselspital Bern-Inselspital Infektiologie ( Site 4403)
🇨🇭Bern, Berne, Switzerland