AV2 Antiviral Spray Versus Placebo in Human Papillomavirus Cervix Infections

Cesa Projects

Status and phase: Unknown; Phase 2

Conditions: Genital Human Papilloma Virus Infection

Treatments: Drug: topical application cervical spray; Procedure: cervical swab with Cervex-Brush-Combi at T0; Drug: topical spray on the cervix; Procedure: cervical swab with Cervex-Brush-Combi at T1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01654822

AV2-HPV-001

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Female

Ages: 25 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

olive oil with 10% d-limonene

Placebo Comparator group

Description:

Topical spray one-time administration 2 puffs of 100µl

Treatment:

Procedure: cervical swab with Cervex-Brush-Combi at T0

Procedure: cervical swab with Cervex-Brush-Combi at T0

Drug: topical spray on the cervix

Procedure: cervical swab with Cervex-Brush-Combi at T1

Procedure: cervical swab with Cervex-Brush-Combi at T1

AV2-DM antiviral spray

Experimental group

Description:

Topical spray one-time application 2 puffs of 100µl

Treatment:

Procedure: cervical swab with Cervex-Brush-Combi at T0

Drug: topical application cervical spray

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 T1