Back to resultsAV2 Antiviral Spray Versus Placebo in Human Papillomavirus Cervix Infections
Primary Purpose
Genital Human Papilloma Virus Infection
Status
Unknown status
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional treatment trial for Genital Human Papilloma Virus Infection focused on measuring HPV, cervix
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.
Sites / Locations
- Labo Riatol
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
olive oil with 10% d-limonene
AV2-DM antiviral spray
Arm Description
Topical spray one-time administration 2 puffs of 100µl
Topical spray one-time application 2 puffs of 100µl
Outcomes
Primary Outcome Measures
Efficacy comparison number of patients with drop (min 2 Log units) in HPV specific viral load AV2-DM versus placebo
Secondary Outcome Measures
number of adverse vents AV2-DM versus placebo
Full Information
NCT ID
NCT01654822
First Posted
June 19, 2012
Last Updated
November 8, 2012
Sponsor
Cesa Projects International
1. Study Identification
Unique Protocol Identification Number
NCT01654822
Brief Title
AV2 Antiviral Spray Versus Placebo in Human Papillomavirus Cervix Infections
Official Title
Single Center, Placebo Controlled, Double-Blind Study to the Treatment of HPV Infected Cervix With AV2 Antiviral Spray and Assessment of Viral Load
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
January 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cesa Projects International
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Human Papilloma Virus Infection
Keywords
HPV, cervix
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
olive oil with 10% d-limonene
Arm Type
Placebo Comparator
Arm Description
Topical spray one-time administration 2 puffs of 100µl
Arm Title
AV2-DM antiviral spray
Arm Type
Experimental
Arm Description
Topical spray one-time application 2 puffs of 100µl
Intervention Type
Drug
Intervention Name(s)
topical application cervical spray
Intervention Description
one time (2 puffs) topical application of 100µl AV2-DM antiviral spray( containing 50% AV2-DM and 50% olive oil)on the cervix
Intervention Type
Drug
Intervention Name(s)
topical spray on the cervix
Intervention Description
one time (2 puffs) topical spray of 100 µl (90% olive oil and 10% d-limonene) on the cervix
Intervention Type
Procedure
Intervention Name(s)
cervical swab with Cervex-Brush-Combi at T0
Intervention Type
Procedure
Intervention Name(s)
cervical swab with Cervex-Brush-Combi at T1
Intervention Type
Procedure
Intervention Name(s)
cervical swab with Cervex-Brush-Combi at T0
Intervention Type
Procedure
Intervention Name(s)
cervical swab with Cervex-Brush-Combi at T1
Primary Outcome Measure Information:
Title
Efficacy comparison number of patients with drop (min 2 Log units) in HPV specific viral load AV2-DM versus placebo
Time Frame
90 days
Secondary Outcome Measure Information:
Title
number of adverse vents AV2-DM versus placebo
Time Frame
90 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Labo Riatol
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
12. IPD Sharing Statement
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AV2 Antiviral Spray Versus Placebo in Human Papillomavirus Cervix Infections
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