AV2 Antiviral Spray Versus Placebo in Human Papillomaviru... | NCT01654822

Studies
AV2 Antiviral Spray Versus Placebo in Human Papillomavirus Cervix Infections

NCT01654822

Sponsor

Cesa Projects International

Status

Unknown status

Last Update Posted

Nov 9, 2012Estimated

Enrollment

100Estimated

Phase

Phase 2

Conditions

Genital Human Papilloma Virus Infection

Interventions

topical application cervical spray
topical spray on the cervix
cervical swab with Cervex-Brush-Combi at T0
cervical swab with Cervex-Brush-Combi at T1
cervical swab with Cervex-Brush-Combi at T0
cervical swab with Cervex-Brush-Combi at T1

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Dec 2012Estimated

Completion Date

Jan 2013Estimated

First Submitted Date

Jun 19, 2012

First Submission Date that Met QC Criteria

Jul 30, 2012

First Posted Date

Aug 1, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2012

Last Update Posted Date

Nov 9, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
olive oil with 10% d-limonene	Placebo Comparator	Topical spray one-time administration 2 puffs of 100µl	Drug: topical spray on the cervix Procedure: cervical swab with Cervex-Brush-Combi at T0 Procedure: cervical swab with Cervex-Brush-Combi at T1
AV2-DM antiviral spray	Experimental	Topical spray one-time application 2 puffs of 100µl	Drug: topical application cervical spray Procedure: cervical swab with Cervex-Brush-Combi at T0 Procedure: cervical swab with Cervex-Brush-Combi at T1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
topical application cervical spray	Drug	one time (2 puffs) topical application of 100µl AV2-DM antiviral spray( containing 50% AV2-DM and 50% olive oil)on the cervix	AV2-DM antiviral spray

Measure	Description	Time Frame
Efficacy comparison number of patients with drop (min 2 Log units) in HPV specific viral load AV2-DM versus placebo		90 days

Measure	Description	Time Frame
number of adverse vents AV2-DM versus placebo		90 days

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided