Trial purpose

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.

View full trial information on Clinicaltrials.gov

NATIONAL TRIAL REFERENCE NUMBER

NCT07266831

When you talk with your doctor or clinical trial team member, please have the national trial reference number available.

Resources

Eligibility

Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.

Conditions

Human Immunodeficiency Virus Type 1 Infection

Age Range

18+

Sex

All

About the trial

Current trial phase

Phase 2

Tests the medicine or vaccine in approximately 100 to 500 participants. In the case of medicines, participants usually have the disease or condition the investigational medicine is designed to treat. In vaccine trials, the participants are usually healthy. Phase 2 trials may happen in a doctor’s office, a clinic, or a hospital.

Phase 3

Tests the medicine or vaccine in approximately 1,000 to 5,000 participants. For medicines, participants have the disease or condition the medicine is designed to treat. In vaccine trials, the participants may be healthy or have diseases or conditions. Phase 3 trials may happen in a doctor’s office, a clinic, or a hospital.

Trial start and end dates
  • Trial start date 12-18-2025
  • Estimated primary completion date 10-05-2029
  • Estimated trial completion date 04-25-2030

Trial locations

Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.

What can you do next?

If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.

Discuss with your doctor or care team

Print this page with details about the trial or email it to your doctor to discuss the clinical trial during your next visit.

Get help talking with your doctor or care team

NATIONAL TRIAL REFERENCE NUMBER

NCT07266831

When you talk with your doctor or clinical trial team member, please have the national trial reference number available.