In breve
Clinical trials are studying Ulonivirine in people with HIV-1 infection. The trials look at how well it works, how safe it is, and how well people tolerate it. The target groups include adults with HIV-1 who have not been treated before and other participants in switch and dose-ranging studies.
Punti chiave
- Clinical trials of Ulonivirine are focused on HIV-1 infection. One completed Phase 2 study looked at safety and tolerability in a dose-ranging and switch setting. Another authorised Phase 4 study is testing Ulonivirine in people with HIV who have not been treated before. The main outcomes include how many participants reach HIV-1 RNA below 50 copies/mL and how many have adverse events. The studies also track how many people stop treatment because of an adverse event. Overall, the trials are studying Ulonivirine as part of HIV treatment research in different patient groups.
Overview of the Ulonivirine studies
The available clinical trials are studying Ulonivirine in people with HIV-1 infection or HIV. These studies are focused on whether the treatment plan is safe, well tolerated, and able to lower the amount of virus in the blood.
One trial is completed and one is authorised, so the research includes both finished and ongoing study planning.
Who is being studied
The studies include people with HIV-1 infection, and one trial specifically focuses on people with HIV-1 who have not been treated before. This means the research is looking at both treatment-naive participants, which means people who have not yet received treatment, and other HIV populations in a switch setting.
The authorised study enrolls a larger group, with 520 participants, while the completed Phase 2 trial enrolled 161 participants.
Study designs and phases
Both studies are interventional trials, which means researchers assign the study treatments rather than only observing what happens in routine care. The completed study is a Phase 2 dose-ranging and switch study, while the authorised study is described as Phase 4.
The Phase 2 trial studied once-weekly treatment strategies, including Ulonivirine as part of the study plan. The authorised study compares once-weekly islatravir and Ulonivirine with a standard daily treatment regimen in people with HIV-1 who have not been treated before.
What the trials measure
The main outcomes in these trials focus on safety, tolerability, and antiretroviral activity, which means how well the treatment controls HIV.
- Adverse events: the studies count how many participants have at least one adverse event, which is any health problem that happens during the trial.
- Stopping study treatment because of an adverse event: the trials measure how many participants stop the study intervention due to a health problem.
- HIV-1 RNA below 50 copies/mL: this is a key effectiveness measure showing how many participants reach a low level of virus in the blood.
In the authorised study, these outcomes are measured at Week 24 for Phase 2 and at Week 48 for Phase 3.
Main trial details
NCT04564547 is a completed Phase 2 study in 161 participants with HIV-1 infection. It was designed as a dose-ranging and switch study and mainly evaluated the safety and tolerability of once-weekly treatment strategies, including Ulonivirine.
2025-522519-40-00 is an authorised Phase 4 study with 520 participants and focuses on people with HIV who have not been treated before. It compares once-weekly islatravir and Ulonivirine with a standard daily regimen, and it measures both virus control and safety over time.
| Trial ID | Title | Phase | Status | Enrollment |
|---|---|---|---|---|
| NCT04564547 | Dose Ranging, Switch Study of ISL and MK‑8507 Once-Weekly | Phase 2 | Completed | 161 |
| 2025-522519-40-00 | A clinical study of islatravir and ulonivirine for people with HIV-1 who have not been treated before (MK-8591B-062) | Phase 4 | Authorised | 520 |
Key points for patients
These trials do not describe Ulonivirine as a stand-alone treatment; instead, they study it as part of HIV treatment combinations. The main questions are whether the treatment plan works, whether it is safe, and whether people can stay on it without major problems.
Because the studies include different phases and different participant groups, they help researchers learn about Ulonivirine in both earlier and later stages of clinical research.