Comparing 4 approaches for human immunodeficiency virus type 1 (HIV-1) infection
Official title: A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
A Phase 2/3, Randomized, Active-Controlled, Open-Label (Phase 2) and Double-Blind (Phase 3) Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily in Treatment-Naïve Adult Participants Living With HIV-1
Interventions
ISL
ISL 2 x 1 mg oral capsules administered qw for 96 weeks
ULO
ULO 2 x 100 mg oral tablets administered qw for 96 weeks
BIC/FTC/TAF
BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks
Placebo for BIC/FTC/TAF
BIC/FTC/TAF-matching placebo oral tablet administered qd for 96 weeks
Placebo to ISL/ULO
ISL/ULO-matching placebo oral tablets administered qw for 96 weeks
ISL/ULO
ISL/ULO fixed-dose combination 2 mg/200 mg oral tablet administered qw for 96 weeks
Canadian Sites (2)
Spectrum Health ( Site 3307)
Vancouver, British Columbia, Canada
Gestion clinique médicale l'Actuel ( Site 3303)
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for9 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →: Is human immunodeficiency virus type 1 (HIV-1) positive with Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies/mL.
- +Phase 3Phase 3A large study comparing a treatment against the current standard.Read more →: Is HIV-1 positive with Plasma HIV-1 RNA ≥500 copies/mL.
- +Is naïve to antiretroviral therapy (ART), defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection.
- +Phase 2: Has cluster of differentiation 4-positive (CD4+) T-cell count ≥200 cells/mm\^3.
Exclusion
- −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) or active hepatitis B virus (HBV) infection.
- −Has a history of malignancy ≤5 years prior to providing documented informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →/3 — a combined study that runs the middle stage and the large comparison stage together.
What is being given or done in this study: ISL, ULO, BIC/FTC/TAF, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → for BIC/FTC/TAF, and 2 more.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 4 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 570 people.
The study is currently expected to finish around April 2030.
The main measurement is taken over: Week 24.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24 — measured over Week 24.
Phase 2: Percentage of Participants Who Experience an Adverse EventAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AE) at Week 24 — measured over Week 24.
Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 24 — measured over Week 24.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more →: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 — measured over Week 48.
The study lists 2 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07266831 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About ISLDrug
ISL 2 x 1 mg oral capsules administered qw for 96 weeks
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About ULODrug
ULO 2 x 100 mg oral tablets administered qw for 96 weeks
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About BIC/FTC/TAFDrug
BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Placebo for BIC/FTC/TAFDrug
BIC/FTC/TAF-matching placebo oral tablet administered qd for 96 weeks
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Placebo to ISL/ULODrug
ISL/ULO-matching placebo oral tablets administered qw for 96 weeks
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About ISL/ULODrug
ISL/ULO fixed-dose combination 2 mg/200 mg oral tablet administered qw for 96 weeks
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Week 24.
The study as a whole is currently expected to finish around 2030-04-03.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 570 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 4 locations, including: Vancouver, British Columbia, Canada; Montreal, Quebec, Canada; Detroit, Michigan, United States; Seattle, Washington, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers want to know if a study ART works as well as a standard ART to treat HIV-1. The study ART combines 2 medicines, islatravir and ulonivirine, and is taken once a week. The goals of this study are to learn: 1) If the study ART works as well as a standard ART to treat HIV-1, and 2) About the safety of the study ART and if people tolerate it compared to a standard ART.
Other Sites (2)
Henry Ford Hospital ( Site 1535)
Detroit, Michigan, United States
Harborview Medical Center ( Site 1526)
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.