Probiotics to Treat HSIL and Reduce Persistent High Risk HPV Infection in Women and Men Living With HIV

This is a randomized double-blinded, placebo-controlled trial. PRIMARY OBJECTIVES: I. Evaluate regression to no disease among people with HIV (PWH) with anal HSIL at baseline at Week 36. II. To determine the safety of EXE-346 in PWH. SECONDARY OBJECTIVES: I. To evaluate regression to LSIL or normal at Week 36 among PWH with anal HSIL at baseline. II. To evaluate clearance at Week 36 to HPV-negative in anal swab for type(s) found at the baseline visit in PWH. EXPLORATORY OBJECTIVES: I. To determine if changes in the microbiome from baseline to Week 36 correlate with regression of anal H…