A clinical study of islatravir and ulonivirine for people with HIV-1 who have not been treated before (MK-8591B-062)
EU CTIS ID: 2025-522519-40-00
What this study is testing
1. Phase 2: To evaluate the antiretroviral activity of ISL+ULO qw compared to BIC/FTC/TAF qd, as assessed by the percentage of participants with HIV-1 RNA <50 copies/mL at Week 24 2. Phase 2: To evaluate the safety and tolerability of ISL+ULO qw compared to BIC/FTC/TAF qd, as assessed by review of accumulated safety data through Week 24 3. Phase 3: To evaluate the antiretroviral activity of ISL/ULO qw compared to BIC/FTC/TAF qd, as assessed by the percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 4. Phase 3: To evaluate the safety and tolerability of ISL/ULO qw compared with BIC/FTC/TAF qd, as assessed by review of accumulated safety data through Week 48
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Is human immunodeficiency virus type 1 (HIV-1) positive with: - Phase 2: Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies/mL. - Phase 3: 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.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- France
- Spain
- Mexico
- Chile
- Guatemala
- Canada
- Japan
- Thailand
- Colombia
- Malaysia
- United States
- Argentina
- South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include France; Spain; Mexico; Chile; Guatemala; Canada and 7 more locations. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.