AV2 Antiviral Spray Versus Placebo in Human Papillomavirus Cervix Infections
This study is ongoing, but not recruiting participants.
Sponsor:
Cesa Projects International
Information provided by (Responsible Party):
Cesa Projects International
ClinicalTrials.gov Identifier:
NCT01654822
First received: June 19, 2012
Last updated: November 8, 2012
Last verified: November 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Genital Human Papilloma Virus Infection |
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 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Further study details as provided by Cesa Projects International:
Primary Outcome Measures:
- Efficacy comparison number of patients with drop (min 2 Log units) in HPV specific viral load AV2-DM versus placebo [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- number of adverse vents AV2-DM versus placebo [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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
Procedure: cervical swab with Cervex-Brush-Combi at T0
Procedure: cervical swab with Cervex-Brush-Combi at T1
|
Eligibility| Ages Eligible for Study: | 25 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Cesa Projects International |
| ClinicalTrials.gov Identifier: | NCT01654822 History of Changes |
| Other Study ID Numbers: | AV2-HPV-001 |
| Study First Received: | June 19, 2012 |
| Last Updated: | November 8, 2012 |
| Health Authority: | Belgium: Ethics Committee |
Keywords provided by Cesa Projects International:
|
HPV cervix |
Additional relevant MeSH terms:
|
Papilloma Virus Diseases Warts Papillomavirus Infections Neoplasms, Squamous Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms DNA Virus Infections |
Skin Diseases, Viral Tumor Virus Infections Skin Diseases, Infectious Skin Diseases Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013