PROTECT Study: Using Probiotics to Treat Pre-Cancerous Anal Lesions in People with HIV

Sponsor: University of California, San Francisco

Sponsor score: 40

ClinicalTrials ID:NCT06949800

Provider View

This study is testing whether a probiotic treatment can help reduce pre-cancerous anal lesions in people living with HIV, aiming to prevent anal cancer in this group.

Patient Parameters

Program Overview

The study is investigating if a probiotic treatment can help reduce or eliminate high-grade squamous intraepithelial lesions (HSIL) in the anal area of people with HIV. The ultimate goal is to prevent anal cancer in this population. Participants will receive either the probiotic treatment or a placebo for up to 12 weeks, with follow-up visits at 24 and 36 weeks. The study will also look at the safety of the treatment and its effects on the body's microbiome.

Description

This clinical trial is designed to see if a probiotic treatment can help reduce or eliminate pre-cancerous anal lesions in people with HIV. The study is double-blinded, meaning neither the participants nor the researchers know who is receiving the probiotic or a placebo. The main goals are to see if the treatment can reduce the lesions to no disease or to a lower grade by week 36, and to check if the treatment is safe. The study will also explore if changes in the body's microbiome are linked to the reduction of lesions or clearance of HPV.

Participants will be randomly assigned to receive either the probiotic treatment or a placebo. They will take the treatment for up to 12 weeks and have follow-up visits at 24 and 36 weeks. If lesions are still present at week 36, standard treatment may be offered. The study will also monitor the safety of the treatment and its impact on the body's microbiome.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed informed consent.
  • Must be part of the ULACNet-101 study or screened for ULACNet-102.
  • Must have biopsy-confirmed anal HSIL.
  • Lesions must be large enough to monitor but cover less than 50% of the anal area.
  • Must be on effective HIV treatment for at least three months before joining the study.
  • HIV RNA levels must be below 200 copies/ml.
  • CD4 count must be above 200 cells/uL.
  • Must be in good general health with a performance status of 1 or less.
  • Must meet specific blood test criteria.
  • Women must not be pregnant or breastfeeding and must use effective contraception if of childbearing potential.

Exclusion Criteria

  • History of any anogenital cancer.
  • Untreated cervical HSIL or cervical cancer.
  • Concerns about cancer in anal HSIL.
  • Recent chemotherapy, radiotherapy, or immunosuppressive medication.
  • Immunosuppression due to illness or treatment.
  • Recent or planned antibiotic treatment.
  • Long-term use of NSAIDs.
  • Allergy to the probiotic treatment.
  • Current COVID-19 infection.
  • Extensive warts that obscure HSIL.
  • Uncontrolled high or low blood pressure.
  • History of significant blood disorders.
  • Uncontrolled illness or psychiatric conditions.
  • Participation in another clinical study within 30 days before screening.
  • Any other condition deemed unsuitable by the investigator.

Locations

FACILITYZIPCITYSTATE
University of California, San Francisco94143San FranciscoCalifornia

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