AV2 Antiviral Spray Versus Placebo in Human Papillomavirus Cervix Infections

This study is ongoing, but not recruiting participants.
Sponsor:
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
  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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654822

Locations
Belgium
Labo Riatol
Antwerpen, Belgium, 2020
Sponsors and Collaborators
Cesa Projects International
  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
Papillomavirus Infections
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
DNA Virus Infections
Tumor Virus Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014