Colvir-PhaseII: Safety and Efficacy Study of Antiviral Local Application to Treat High Grade Cervical Intraepithelial Lesions (CIN2/3)

• Sponsor: Mithra Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01303328
• Collaborator: (none)
• Enrollment: 200
• Locations: 9
• Arms: 2
• Duration (Months): 23.1
• Patients Per Site: 22.2
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The purpose of this phase-II study is to evaluate the efficacy and safety of an aqueous gel containing an antiviral, administered directly on cervix exhibiting high grade squamous or glandular intraepithelial lesion (CIN 2 and 3) in comparison with a placebo treatment.

Condition or Disease	Intervention/Treatment	Phase
Uterine Cervical Neoplasia; Cervix Intraepithelial Neoplasia	Drug: C1	Phase 2

Detailed Description

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 antiviral would preserve the cervix of young subjects and reduce obstetrical morbidity induced by the conisation.

This clinical study is aimed at:

• to evaluate the efficacy of a gel with antiviral directly applied on the cervix exhibiting high grade CIN lesions (CIN2/3): conisation is still indicated?

• to evaluate the safety and tolerance after local application.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Multi-centre, Placebo Controlled Phase II Clinical Study to Evaluate the Efficacy, Tolerance and Safety of an Aqueous Gel Containing an Antiviral, Directly Applied on the Cervix Exhibiting High Grade Intraepithelial Lesion.
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group	Drug: C1; Local application of the experimental gel or placebo gel.
Placebo Comparator: Placebo group	Drug: C1; Local application of the experimental gel or placebo gel.

Outcome Measures

Primary Outcome Measures

1. Efficacy at week 12: change of histological and cytological parameters (success or not) [12 weeks]

   Efficacy will be measured by histological and cytological criteria at week 12 (disappearance of CIN 2+) in correlation with viral status (positive or negative) before and after treatment.

2. Efficacy at week 28: recurrence rate [28 weeks]

   The recurrence rate will be assessed at week 28, by the same histological and cytological criteria in correlation with the viral status (positive or negative) before and after treatment.

3. Tolerance and Safety (AE reporting, changes of gynecological and biological parameters) [during 30 weeks]

   Safety will be measured by record of adverse events, changes in clinical biology test results; local tolerance will be measured by patient questioning and gynecological examination of vagina and cervix.

Secondary Outcome Measures

1. Virological status (infection) [during 30 weeks]

   The viral load and genotypes of HPVhr will be determined before treatment, during follow-up and at the end of the study, by using a quantitative analysis.

2. Changes in lesion (colposcopic changes) [during 30 weeks]

   Colposcopic description of lesion will be done before, during and after treatment of the lesion, during follow up and at the end of the study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Women aged between 18 and 50 years old

• Informed consent signed

• Cervical lesion classified CIN 2 or 3, on a biopsy made during the 60 days before inclusion

• No sexual activity, or proved sterility, or use of effective mechanical, hormonal or intrauterine contraception during 30 days following inclusion (except vaginal ring Nuvaring, diaphragm and spermicide)

Exclusion Criteria:

• Invasive or microinvasive cervical neoplasia

• Pregnancy or breast feeding

• Subtotal hysterectomy

• Current renal impairment

• Current immune disorder including serology HIV +

• Current use of drugs interfering with renal function

• Current use of oncologic treatment

• Current use of immune treatment

• Current use of anti-viral treatment

• Current vaginal application of drugs or cosmetics

• Prior treatment with the antiviral on the cervix

• Local or general condition incompatible with the experimental treatment in the opinion of the principal investigator

• Current or recent participation to another experimental study during the last 3 months before the screening visit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HIS Ixelles	Ixelles	Bruxelles	Belgium	1050
2	CHU Charleroi Site André Vésale	Montigny-le-Tilleul	Charleroi	Belgium	6110
3	CHU ND des Bruyères	Chenee	Liege	Belgium	4032
4	Hôpital Saint Pierre	Bruxelles		Belgium	1000
5	CHU Brugmann	Bruxelles		Belgium	1020
6	Hôpital Erasme	Bruxelles		Belgium	1070
7	CHU Charleroi Hôpital Civil	Charleroi		Belgium	6000
8	CHU Tivoli	La Louvière		Belgium	7100
9	CHR Citadelle	Liege		Belgium	4000

Sponsors and Collaborators

• Mithra Pharmaceuticals

Investigators

• Principal Investigator: Philippe SIMON, MD, PhD, Professor, Hôpital Erasme, service de gynécologie obstétrique

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01303328
• Other Study ID Numbers: MI-CI-C02; 2010-023271-26
• First Posted: Feb 24, 2011
• Last Update Posted: Feb 18, 2013
• Last Verified: Aug 1, 2012

• Additional relevant MeSH terms: Neoplasms; Cervical Intraepithelial Neoplasia

Study Results

No Results Posted as of Feb 18, 2013