Recruiting

Testing a new immune therapy dose for people with well-controlled HIV

Plain-English translation of NCT05187429 on ClinicalTrials.gov ↗ · Source last updated December 2025 · Translation generated June 2026 · How we translate trials

Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.

What is this trial?

This trial is testing a medication called Nivolumab to see if it can help people living with HIV who are already on antiretroviral therapy (HIV medications). The study has two parts: first, researchers will test different doses of the medication to find the safest amount, and then they will test whether the medication helps the body control HIV better, even if regular HIV medications are paused for a short time.

Even though modern HIV medications work very well to keep the virus undetectable, they don't cure HIV, and most people need to take them for life. This trial is exploring whether this medication could help boost the immune system to better control HIV on its own.

Do you qualify?

You likely qualify if…

you have been living with HIV for several years and have an undetectable viral load (less than 50 copies) for at least 2 years
you have been on the same combination of HIV medications for at least 4 weeks and are willing to continue them throughout the study
you weigh at least 110 pounds (50 kg)
your CD4+ T cell count (a measure of immune health) is above 500 cells per microliter
if female, you are either not able to become pregnant, or you agree to use effective contraception during the study and have a negative pregnancy test

You likely don't qualify if…

you have not been on stable HIV medications for at least 4 weeks
your HIV viral load has not been undetectable (below 50 copies) for the past 2 years
you have a CD4+ T cell count below 500 cells per microliter
you are pregnant, planning to become pregnant, or unwilling to use contraception during the study

What participation looks like

If you join, you would first go through a screening visit where your HIV levels and immune health are checked. Then you would receive a single infusion of either the medication or a placebo (salt water), which takes a few hours. In the second part of the study, some participants will have the option to pause their regular HIV medications for up to 6 months while researchers monitor how well their immune system controls the virus, before restarting treatment. You would have multiple follow-up visits over about 6 to 8 months total to have blood tests and check-ins.

AI-generated summary from trial data · Jun 3, 2026 · Not medical advice

Trial locations(2 sites)

Australia

Alfred Hospital - Department of Infecious Diseases, Melbourne, Victoria

Singapore

Tan Tock Seng Hospital, Singapore