Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV

"ACU-D1 is a topical therapeutic agent that has pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate) (PTTC) as its major active ingredient. PTTC is a novel proteasome inhibitor that has antiangiogenic and anti-inflammatory activities that reduce pro-inflammatory cytokines. ACU-D1 ointment contains a range of 2.5% to 10% weight by volume of PTTC.~Level 1 will consist of 2.5% ACU-D1 ointment, used twice daily for 4 weeks."

Level 2 will consist of 5% ACU-D1 ointment, used twice daily for 4 weeks.

Level 3 will consist of 10% ACU-D1 ointment, used twice daily for 4 weeks.

3 vulvar or perianal biopsies are to be performed at the screening as well as at the end of the study (week 4).