Clinical Trial Details

Primary Objective:

• To evaluate efficacy of EXE-346 to induce regression of anal HSIL (i.e.,HSIL at baseline to no disease) at Week 36 among people with HIV (PWH).

• To determine the safety of EXE346 in PWH.

Secondary Objectives:
To evaluate efficacy of EXE-346 to induce at least partial regression of anal HSIL (i.e., HSIL at baseline to LSIL or no disease) at Week 36 among PWH

• To evaluate efficacy of EXE-346 to induce clearance of HPV in anal swabs (i.e., overall/type-specific HPV positive at baseline to overall/type-specific HPV negative) at Week 36 among PWH.

Exploratory Objectives:

• To determine if changes in the microbiome (i.e., changes from baseline to Week 36) linked to the
  use of EXE-346 correlate with anal HSIL regression (i.e., anal HSIL to LSIL and/or no disease) or clearance of HPV (i.e., overall/typespecific HPV positive at baseline to overall/type-specific HPV negative) at Week 36.