Safety and efficacy of topical cidofovir to treat high-grade perianal and vulvar intraepithelial neoplasia in HIV-positive men and women.

ABSTRACT:

Objective

To evaluate the safety and efficacy of topical cidofovir for treatment of high-grade squamous perianal intraepithelial neoplasia (PAIN) and vulvar intraepithelial neoplasia (VIN) lesions in HIV-positive individuals.

Design

Phase IIa prospective multicenter trial conducted at eight clinical sites through the AIDS Malignancy Consortium.

Methods

: HIV-positive patients with biopsy-proven high-grade PAIN that was at least 3 cm were enrolled. PAIN biopsy specimens were assessed for human papillomavirus (HPV) using PCR and type-specific HPV probing. Participants applied 1% topical cidofovir to PAIN and VIN (if present) for six 2-week cycles. Results were designated as complete response (CR), partial response (PR) (>50% reduction in size), stable disease, or progre

SUBMITTER: Stier EA 

PROVIDER: S-EPMC3759510 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature