Phase II double-blind, placebo-controlled study of the safety and efficacyof cidofovir topical gel for the treatment of patients with human papillomavirus infection

Genital condylomata acuminata are nonmalignant human papillomavirus (HPV)-i nduced tumors in which HPV types 6 and 11 are most commonly found. Usual tr eatments for condylomata acuminata are nonspecific and are based on the des truction or removal of infected tissue. These procedures are often painful and are characterized by a high relapse rate. We report here what is to our knowledge the first double-blind, placebo-controlled study of the use of c idofovir, a nucleotide analogue, for the treatment of genital papillomaviru s infections. Thirty patients were enrolled in the study; 19 received cidof ovir, and 11 received placebo. The median number of warts and the median ba seline wart area were comparable for both groups. Nine (47%) of 19 patients in the cidofovir group had a complete response (total healing), compared w ith 0 of the patients in the placebo group (P=.006). None of the patients i n the cidofovir group experienced progression of the disease, compared with 5 (45%) of 11 patients in the placebo group. The side effects recorded for both groups were comparable.