Probiotics to treat precancerous anal lesions in people with HIV

Plain-English translation of NCT06949800 on ClinicalTrials.gov ↗ · Source last updated September 2026 · Translation generated September 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 probiotic medication called EXE-346 to see if it can help treat precancerous lesions (called HSIL) in the anal area and clear a persistent virus (HPV) in people living with HIV. Researchers believe that changing the bacteria in your body with this medication might help your immune system fight these lesions on its own. The study will compare this medication to a placebo (a dummy pill) to see which works better.

Precancerous lesions in the anal area are common in people living with HIV and often require surgery to remove. This medication might offer a non-surgical way to treat these lesions by working with your body's natural defenses, potentially preventing the need for more invasive procedures.

Do you qualify?

You likely qualify if…

you have been diagnosed with precancerous anal lesions (HSIL) that were confirmed by biopsy
you are living with HIV and have been on stable HIV medications for at least three months with an undetectable viral load
your immune system is strong enough (CD4 count has been above 200 cells in the past)
you are in reasonable overall health and able to participate in visits over nine months
if you can become pregnant, you agree to use effective birth control during the study and for two weeks after stopping the medication

You likely don't qualify if…

you have a history of cancer in the anal or genital area
you have untreated precancerous or cancerous lesions of the cervix
you have received chemotherapy, radiation, or immunosuppressive medications in the three months before enrollment
you are pregnant or breastfeeding
your precancerous lesions are so extensive (covering more than half the anal area) that researchers are concerned about cancer

What participation looks like

You will take sachets of the medication (or placebo) mixed in water twice daily for 12 weeks. You'll visit the clinic at baseline for a biopsy and confirmation, then return for check-up visits at 12 weeks, 24 weeks, and 36 weeks. At some of these visits, doctors will examine your anal area and may take swabs to check if the lesions are improving and if the HPV virus is clearing. If your lesions haven't fully healed by week 36, you can receive standard surgical treatment. The entire study lasts about nine months.

AI-generated summary from trial data · Sep 24, 2026 · Not medical advice

Trial locations(2 sites)

United States

University of California, San Francisco, San Francisco, California

Puerto Rico

University of Puerto Rico Comprehensive Cancer Center, San Juan