Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions

Mithra Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Uterine Cervical Neoplasms; Cervix Intraepithelial Neoplasia

Treatments: Drug: Cidofovir gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00989443

MI-COL-CI01

EudraCT2009-012937-31

Details and patient eligibility

About

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.

Enrollment: 6 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women aged between 18 and 50 years old
• volunteers
• informed consent signed
• cervical lesion classified CIN 2 or 3, on a biopsy made during the 6 preceding weeks
• no sexual activity or use of effective mechanical, hormonal or intrauterine contraception (except hormonal vaginal ring)

Exclusion criteria

• pregnancy or breast feeding
• subtotal hysterectomy
• current or ancient renal impairment
• current immune disorder
• current use of drugs interfering with renal function
• current treatment for any cancer
• current use of treatment interfering with immunity
• current use of anti-viral treatment
• current or recent participation to another experimental study during the last 3 months before the screening visit
• current vaginal application of drugs or cosmetics
• local or general condition incompatible with the experimental treatment in the opinion of the principal investigator

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Cidofovir

Experimental group

Treatment:

Drug: Cidofovir gel