AV2 Antiviral Spray Versus Placebo in Human Papillomavirus Cervix Infections

Genital Human Papilloma Virus Infection Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01654822
• Other study ID #: AV2-HPV-001
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 19, 2012
• Last updated: November 8, 2012
• Start date: August 2012
• Est. completion date: January 2013

Study information

• Verified date: November 2012
• Source: Cesa Projects International
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Genital Human Papilloma Virus Infection
• Papillomavirus Infections
• Virus Diseases

Intervention

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
• 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

• cervical swab with Cervex-Brush-Combi at T1

• cervical swab with Cervex-Brush-Combi at T0

• cervical swab with Cervex-Brush-Combi at T1

Locations

Country	Name	City	State
Belgium	Labo Riatol	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
Cesa Projects International

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy comparison number of patients with drop (min 2 Log units) in HPV specific viral load AV2-DM versus placebo		90 days	No
Secondary	number of adverse vents AV2-DM versus placebo		90 days	Yes