AV2 Antiviral Spray Versus Placebo in Human Papillomavirus Cervix Infections

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

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

Study Overview

• Status: Unknown
• Conditions: Genital Human Papilloma Virus Infection
• Intervention / Treatment: Drug: topical spray on the cervix; Procedure: cervical swab with Cervex-Brush-Combi at T0; Procedure: cervical swab with Cervex-Brush-Combi at T1; Drug: topical application cervical spray

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium, 2020
    • Labo Riatol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women between 25 and 40 years
2. Patient has been recently (up to 6 months) Quantitatively (Viral Load) and Qualitatively (HPV types) diagnosed with HPV.
3. Ability and willingness to participate in the study.
4. Subject agrees to refrain from using prescription or supplemental antiviral medications without obtaining permission of the Treating Doctor.
5. Voluntary written informed consent.

Exclusion Criteria:

1. Subject has been vaccinated against HPV
2. Interval between a delivery and T0 is less than 3 months
3. Subject has a gynecologic surgical intervention between T0 and T1
4. Subject is diagnosed HPV negative at T0
5. Subject has a (adeno)carcinoma in situ.
6. Females with child bearing potential who are not using a reliable, medically accepted method of birth control
7. Pregnant or breast-feeding female, or women planning to become pregnant during the trial.
8. Medical history of immunosuppression by radiotherapy, chemotherapy, immuno-modulatory drugs, or HIV.
9. Participation to another clinical trial concerning HPV infections within 6 months before the application of AV2-DM antiviral spray.
10. 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.
11. 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.
12. Known or suspected allergic or adverse response to the investigational product AV2-DM Antiviral spray, it's components, olive oil or d-limonene.
13. Inability to follow the study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: olive oil with 10% d-limonene; Topical spray one-time administration 2 puffs of 100µl	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
EXPERIMENTAL: AV2-DM antiviral spray; Topical spray one-time application 2 puffs of 100µl	Procedure: cervical swab with Cervex-Brush-Combi at T0; Procedure: cervical swab with Cervex-Brush-Combi at T1; 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cesa Projects International

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ANTICIPATED): December 1, 2012
• Study Completion (ANTICIPATED): January 1, 2013

Study Registration Dates

• First Submitted: June 19, 2012
• First Submitted That Met QC Criteria: July 30, 2012
• First Posted (ESTIMATE): August 1, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 9, 2012
• Last Update Submitted That Met QC Criteria: November 8, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: HPV; cervix
• Additional Relevant MeSH Terms: Virus Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; DNA Virus Infections; Tumor Virus Infections; Neoplasms, Squamous Cell; Infections; Papillomavirus Infections; Papilloma
• Other Study ID Numbers: AV2-HPV-001