Human Immunodeficiency Virus Type 1 (HIV-1) InfectionPhase 2NCT06891066
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)
A Phase 2 study testing ISL, ULO and BIC/FTC/TAF in people with Human Immunodeficiency Virus Type 1 (HIV-1) Infection, run by Merck Sharp & Dohme LLC at 23 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus Type 1 (HIV-1) Infection
- What is being tested?
- ISL, ULO and BIC/FTC/TAF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 23 sitesin 4 countries
- Study dates
- 14 Apr 2025to 30 Sep 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
United States11 sites
Central Texas Clinical Research ( Site 4100)
Austin, Texas, 78705
Prism Health North Texas, Oak Cliff Health Center ( Site 4114)
Dallas, Texas, 75208
Regional Center for Infectious Diseases ( Site 4115)
Greensboro, North Carolina, 27401
KC CARE Health Center ( Site 4101)
Kansas City, Missouri, 64111
DCOL Center for Clinical Research ( Site 4112)
Longview, Texas, 75605
Orlando Immunology Center ( Site 4103)
Orlando, Florida, 32803
Zuckerberg San Francisco General Hospital and Trauma Center ( Site 4107)
San Francisco, California, 94110
Chatham County Health Department - Chatham CARE Center ( Site 4116)
Savannah, Georgia, 31401
Georgetown University Medical Center ( Site 4106)
Washington D.C., District of Columbia, 20007
Mills Clinical Research ( Site 4109)
West Hollywood, California, 90046
Triple O Research Institute ( Site 4111)
West Palm Beach, Florida, 33407
Australia5 sites
Momentum Clinical Research - Darlinghurst ( Site 4260)
Darlinghurst, New South Wales, 2010
St. Vincent's Hospital ( Site 4263)
Darlinghurst, New South Wales, 2010
Momentum Clinical Research Fortitude Valley ( Site 4261)
Fortitude Valley, Queensland, 4006
The Alfred Hospital ( Site 4264)
Melbourne, Victoria, 3004
Prahran Market Clinic ( Site 4262)
Prahran, Victoria, 3181
Switzerland4 sites
University Hospital Basel-Infectiology ( Site 4402)
Basel, Canton of Basel-City, 4031
Inselspital Bern-Inselspital Infektiologie ( Site 4403)
Bern, Canton of Bern, 3010
Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 4404)
Geneva, Canton of Geneva, 1205
Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 4405)
Lugano, Canton Ticino, 6900
Puerto Rico3 sites
Ponce Medical School Foundation Inc./CAIMED Center ( Site 4301)
Ponce, 00716
Clinical Research Puerto Rico ( Site 4300)
San Juan, 00909
HOPE Clinical Research ( Site 4303)
San Juan, 00909
About this study
Official title: A Phase 2b, Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Islatravir (ISL) and Ulonivirine (ULO) Once Weekly in Adults With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily
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.
- Being tested
- ISL, ULO, BIC/FTC/TAF
- Keywords
- HIV-1
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISLDrug
Also called MK-8591, Islatravir
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.
ULODrug
Also called MK-8507, Ulonivirine.
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.
BIC/FTC/TAFDrug
Also called BIKTARVY®
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.
| Study group | Role | What they receive |
|---|---|---|
| ISL + ULO in Group 1 | Experimental | 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. Receives: Drug: ISL; Drug: ULO |
| BIC/FTC/TAF in Group 2 | Active comparator | In part 1 of the study, participants will receive BIC 50mg/FTC 200mg/TAF 25mg orally once daily (QD) for 48 weeks. Receives: Drug: BIC/FTC/TAF |
| ISL + ULO in Group 2 | Experimental | 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. Receives: Drug: ISL; Drug: ULO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to ~ 96 weeks
Percentage of Participants Discontinuing Study Treatment due to AEs
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.
Measured: Up to ~ 96 weeks
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 24
Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at 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.
Measured: Week 48
Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at 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.
Measured: Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start14 Apr 2025
- Primary completion10 Aug 2027 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus Type 1 (HIV-1) InfectionStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891066
- Sponsor's protocol ID
- 8591B-060
- Other IDs
- MK-8591B-060
- Status last verified
- Oct 2025
- First submitted
- 17 Mar 2025
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Islatravir (ISL) and Ulonivirine (ULO) Once Weekly in Adults With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily
- ClinicalTrials.gov ID
- NCT06891066
- Acronym / sponsor ID
- 8591B-060
- Keywords
- HIV-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 10 Aug 2027 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ISL + ULO in Group 1 | Experimental | Drug: ISL, Drug: ULOIn 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 | Active comparator | Drug: BIC/FTC/TAFIn 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 | Experimental | Drug: ISL, Drug: ULOIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISLAlso: MK-8591, IslatravirISL 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. | Drug | ISL + ULO in Group 1, ISL + ULO in Group 2 |
| ULOAlso: MK-8507, Ulonivirine.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. | Drug | ISL + ULO in Group 1, ISL + ULO in Group 2 |
| BIC/FTC/TAFAlso: BIKTARVY®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. | Drug | BIC/FTC/TAF in Group 2 |
Primary outcome
Percentage of Participants With HIV-1 RNA ≥50 copies/mL at Week 24
Time frame: 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)
Time frame: 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
Time frame: 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.
14 secondary outcomes
Percentage of Participants With HIV-1 RNA ≥50 copies/mL at Week 48
Time frame: Week 48
Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 24
Time frame: Week 24
Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 48
Time frame: Week 48
Percentage of Participants With HIV-1 RNA <200 copies/mL at Week 24
Time frame: Week 24
Percentage of Participants With HIV-1 RNA <200 copies/mL at Week 48
Time frame: Week 48
Percentage of Participants With HIV-1 RNA ≥50 copies/mL at Week 96
Time frame: Week 96
Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 96
Time frame: Week 96
Percentage of Participants With HIV-1 RNA <200 copies/mL at Week 96
Time frame: Week 96
Mean Change From Baseline in CD4+ T-cell Count at Week 24
Time frame: Week 24
Mean Change From Baseline in CD4+ T-cell Count at Week 48
Time frame: Week 48
Mean Change From Baseline in CD4+ T-cell Count at Week 96
Time frame: Week 96
Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ISL, ULO and BIC/FTC/TAF in people with Human Immunodeficiency Virus Type 1 (HIV-1) Infection, run by Merck Sharp & Dohme LLC at 23 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Australia, Switzerland, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With HIV-1 RNA ≥50 copies/mL at Week 24 (time frame: Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.