Recruiting

Testing a new HIV medication in people newly diagnosed

Plain-English translation of NCT07202546 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing a new HIV medication called to see if it works well for people newly diagnosed with HIV who have never been treated before. The study compares two different doses of this medication—each combined with two other standard HIV drugs—against a well-established HIV treatment regimen. The goal is to find out if this new treatment is effective and determine the best dose to use.

While current HIV treatments work well for many people, researchers are always looking for newer options that might be more convenient, easier to tolerate, or work better for certain patients. This trial tests whether this medication could become another effective choice for people starting HIV treatment for the first time.

Do you qualify?

You likely qualify if…

you are at least 18 years old
you have been newly diagnosed with HIV and have never taken HIV medications before
you have a CD4+ T-cell count above 200 cells per microliter at screening
you weigh at least 110 pounds (if assigned male at birth) or 99 pounds (if assigned female at birth)
you have a body mass index (BMI) between 18.5 and 35.5
you are willing and able to give informed consent

You likely don't qualify if…

you are pregnant, planning to become pregnant, or breastfeeding
you have severe HIV-related infections or illnesses (CDC Stage 3 disease)
you have serious liver disease or a history of cirrhosis
you have hepatitis C or hepatitis B co-infection
you have early or acute HIV infection (diagnosed within the last 3 months)

What participation looks like

If you enroll, you will take one of three different daily pill combinations for at least one year. Some participants will take the new medication at a lower dose, some at a higher dose, and others will take the standard HIV treatment regimen as a comparison. You will have regular clinic visits to check your health, have blood tests done, and be monitored to see how well the treatment is working. The study lasts up to two years for some participants, depending on which treatment group you are assigned to.

AI-generated summary from trial data · Jun 6, 2026 · Not medical advice

Trial locations(123 sites)

United States

GSK Investigational Site, Bakersfield, California

GSK Investigational Site, Palm Springs, California

GSK Investigational Site, West Hollywood, California

GSK Investigational Site, Aurora, Colorado

GSK Investigational Site, New Haven, Connecticut