Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Human Papilloma Virus (HPV) infections induce cervical intraepithelial neoplasia (CIN) of
cervix. To reduce incidence of invasive tumor associated with high grade CIN lesions, the
standard treatment is the conisation of cervix (surgical act). A local treatment with the
antiviral and anti-proliferative cidofovir would preserve the cervix of young subjects and
reduce obstetrical morbidity induced by the conisation.
This clinical study is aimed at :
1. evaluating the tolerance and safety of a cidofovir gel directly applied on the cervix
exhibiting high grade CIN lesions;
2. evaluating the pharmacokinetic (PK) profile of cidofovir after local application.