About this trial
This study is focused on treatment of anal high-grade squamous intraepithelial lesions (HSIL) in persons with HIV (PWH), with the ultimate goal of applying the approach toward prevention of anal cancer in this population
Eligibility criteria
Qualifiers
Signed informed consent
Participant in ULACNet-101 or participant screened specifically for ULACNet-102.
Biopsy-proven anal HSIL (men or women) shown as part of participation in the ULACNet-101 study or at a screening visit for ULACNet-102.
At least one focus of anal HSIL must be large enough to be monitored for response, i.e.,not completely removed after the screening biopsy.
Disqualifiers
History of any anogenital cancer.
Presence of untreated cervical HSIL or cervical cancer.
Anal HSIL on clinical examination or biopsy that clinicians are concerned for cancer.
Receipt of chemotherapy, radiotherapy or immunosuppressive medication in three months preceding enrollment in ULACNet-101 or at the screening visit for ULACNet-102.
Trial design
Treatments tested in this trial
- EXE-346 Probiotic
- Placebo
- Usual Care High Resolution Anoscopy (HRA)
Treatment groups
Sponsors and collaborators
University of California, San Francisco
Lead sponsor
Exegi Pharma, LLC
Collaborator
National Cancer Institute (NCI)
Collaborator