NCT07266831 · Merck Sharp & Dohme LLC
A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
ISL
ISL 2 x 1 mg oral capsules administered qw for 96 weeks
DRUG
ULO
ULO 2 x 100 mg oral tablets administered qw for 96 weeks
DRUG
BIC/FTC/TAF
BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks
DRUG
Placebo for BIC/FTC/TAF
BIC/FTC/TAF-matching placebo oral tablet administered qd for 96 weeks
DRUG
Placebo to ISL/ULO
ISL/ULO-matching placebo oral tablets administered qw for 96 weeks
DRUG
ISL/ULO
ISL/ULO fixed-dose combination 2 mg/200 mg oral tablet administered qw for 96 weeks
Primary outcome measures
Phase 2: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (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.
Phase 2: Percentage of Participants Who Experience an Adverse Event (AE) at Week 24
Time frame: Week 24
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 24
Time frame: Week 24
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
Time frame: 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.
Phase 3: Percentage of Participants Who Experience an AE at Week 48
Time frame: Week 48
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 48
Time frame: Week 48
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Phase 2: Is human immunodeficiency virus type 1 (HIV-1) positive with Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies/mL.
- Phase 3: Is HIV-1 positive with Plasma HIV-1 RNA ≥500 copies/mL.
- Phase 2: Has cluster of differentiation 4-positive (CD4+) T-cell count ≥200 cells/mm\^3.
- Is naïve to antiretroviral therapy (ART), defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection.
Exclusion criteria
- 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 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.
Where
- Los Angeles, California
- Denver, Colorado
- Washington D.C., District of Columbia
- Ft. Pierce, Florida
- Miami Gardens, Florida
- Orlando, Florida
- Sarasota, Florida
- West Palm Beach, Florida
- Decatur, Georgia
- Macon, Georgia
- Chicago, Illinois
- Detroit, Michigan
And 11 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 10, 2026 · Source of record for eligibility and locations