AV2 Antiviral Spray Versus Placebo in Human Papillomavirus Cervix Infections

Study Overview
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Brief Summary
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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

Official Title
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Single Center, Placebo Controlled, Double-Blind Study to the Treatment of HPV Infected Cervix With AV2 Antiviral Spray and Assessment of Viral Load

Conditions
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Genital Human Papilloma Virus Infection

Intervention / Treatment
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* Drug: topical application cervical spray
* Drug: topical spray on the cervix
* Procedure: cervical swab with Cervex-Brush-Combi at T0
* Procedure: cervical swab with Cervex-Brush-Combi at T1
* Procedure: cervical swab with Cervex-Brush-Combi at T0
* Procedure: cervical swab with Cervex-Brush-Combi at T1


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: olive oil with 10% d-limonene<br>Topical spray one-time administration 2 puffs of 100µl | Drug: topical spray on the cervix<br>* one time (2 puffs) topical spray of 100 µl (90% olive oil and 10% d-limonene) on the cervix<br>Procedure: cervical swab with Cervex-Brush-Combi at T0<br> <br> Procedure: cervical swab with Cervex-Brush-Combi at T1<br> <br> |
| Experimental: AV2-DM antiviral spray<br>Topical spray one-time application 2 puffs of 100µl | Drug: topical application cervical spray<br>* one time (2 puffs) topical application of 100µl AV2-DM antiviral spray( containing 50% AV2-DM and 50% olive oil)on the cervix<br>Procedure: cervical swab with Cervex-Brush-Combi at T0<br> <br> Procedure: cervical swab with Cervex-Brush-Combi at T1<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, cervix