NCT07266831 A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
| NCT ID | NCT07266831 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Merck Sharp & Dohme LLC |
| Condition | Human Immunodeficiency Virus Type 1 (HIV-1) Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 570 participants |
| Start Date | 2025-12-18 |
| Primary Completion | 2029-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 570 participants in total. It began in 2025-12-18 with a primary completion date of 2029-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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 and ≤1,000,000 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.
Contact & Investigator
Medical Director
STUDY DIRECTOR
Merck Sharp & Dohme LLC
Frequently Asked Questions
Who can join the NCT07266831 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Human Immunodeficiency Virus Type 1 (HIV-1) Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07266831 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07266831 currently recruiting?
Yes, NCT07266831 is actively recruiting participants. Contact the research team at Trialsites@msd.com for enrollment information.
Where is the NCT07266831 trial being conducted?
This trial is being conducted at Los Angeles, United States, Denver, United States, Washington D.C., United States, Ft. Pierce, United States and 11 additional locations.
Who is sponsoring the NCT07266831 clinical trial?
NCT07266831 is sponsored by Merck Sharp & Dohme LLC. The principal investigator is Medical Director at Merck Sharp & Dohme LLC. The trial plans to enroll 570 participants.
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