AV2 Antiviral Spray Versus Placebo in Human Papillomavirus Cervix Infections

This study is currently recruiting participants.

Verified September 2012 by Cesa Projects International

Sponsor:

Information provided by (Responsible Party):

Cesa Projects International

ClinicalTrials.gov Identifier:

NCT01654822

First received: June 19, 2012

Last updated: September 17, 2012

Last verified: September 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 19, 2012
Last Updated Date	September 17, 2012
Start Date ^ICMJE	August 2012
Estimated Primary Completion Date	November 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 30, 2012)	Efficacy comparison number of patients with drop (min 2 Log units) in HPV specific viral load AV2-DM versus placebo [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01654822 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 30, 2012)	number of adverse vents AV2-DM versus placebo [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	AV2 Antiviral Spray Versus Placebo in Human Papillomavirus Cervix Infections
Official Title ^ICMJE	Single Center, Placebo Controlled, Double-Blind Study to the Treatment of HPV Infected Cervix With AV2 Antiviral Spray and Assessment of Viral Load
Brief Summary	This study aims to prove that, by a one-time topical spray on the cervix, AV2-DM is an effective antiviral in reducing on short term (3 months) the human papillomavirus (HPV) infection. Primary endpoint: significant drop in viral load AV2-DM versus placebo Secondary endpoint:the number of patients with adverse events
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Genital Human Papilloma Virus Infection
Intervention ^ICMJE	Drug: topical application cervical spray one time (2 puffs) topical application of 100µl AV2-DM antiviral spray( containing 50% AV2-DM and 50% olive oil)on the cervix Drug: topical spray on the cervix one time (2 puffs) topical spray of 100 µl (90% olive oil and 10% d-limonene) on the cervix Procedure: cervical swab with Cervex-Brush-Combi at T0 Procedure: cervical swab with Cervex-Brush-Combi at T1
Study Arm (s)	Placebo Comparator: olive oil with 10% d-limonene Topical spray one-time administration 2 puffs of 100µl Interventions: Drug: topical spray on the cervix Procedure: cervical swab with Cervex-Brush-Combi at T0 Procedure: cervical swab with Cervex-Brush-Combi at T1 Experimental: AV2-DM antiviral spray Topical spray one-time application 2 puffs of 100µl Interventions: Drug: topical application cervical spray Procedure: cervical swab with Cervex-Brush-Combi at T0 Procedure: cervical swab with Cervex-Brush-Combi at T1
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	100
Estimated Completion Date	December 2013
Estimated Primary Completion Date	November 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Women between 25 and 40 years Patient has been recently (up to 6 months) Quantitatively (Viral Load) and Qualitatively (HPV types) diagnosed with HPV. Ability and willingness to participate in the study. Subject agrees to refrain from using prescription or supplemental antiviral medications without obtaining permission of the Treating Doctor. Voluntary written informed consent. Exclusion Criteria: Subject has been vaccinated against HPV Interval between a delivery and T0 is less than 3 months Subject has a gynecologic surgical intervention between T0 and T1 Subject is diagnosed HPV negative at T0 Subject has a (adeno)carcinoma in situ. Females with child bearing potential who are not using a reliable, medically accepted method of birth control Pregnant or breast-feeding female, or women planning to become pregnant during the trial. Medical history of immunosuppression by radiotherapy, chemotherapy, immuno-modulatory drugs, or HIV. Participation to another clinical trial concerning HPV infections within 6 months before the application of AV2-DM antiviral spray. Medical history of any severe diseases like hepatitis, renal or liver dysfunction, car-diovascular, gastrointestinal, malignant tumor(s), or psychiatric disorders etc., which might influence the assessments or conduct of the trial by the discretion of the investigator. Intake or application of antivirals or other prohibited concomitant medication within 30 days prior to application of AV2, or patients who plan to take such drugs during the trial. Known or suspected allergic or adverse response to the investigational product AV2-DM Antiviral spray, it's components, olive oil or d-limonene. Inability to follow the study protocol.
Gender	Female
Ages	25 Years to 40 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE
Location Countries ^ICMJE	Belgium

Administrative Information
NCT Number ^ICMJE	NCT01654822
Other Study ID Numbers ^ICMJE	AV2-HPV-001
Has Data Monitoring Committee	No
Responsible Party	Cesa Projects International
Study Sponsor ^ICMJE	Cesa Projects International
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Cesa Projects International
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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