NCT01654822

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

November 9, 2012

Status Verified

November 1, 2012

Enrollment Period

4 months

First QC Date

June 19, 2012

Last Update Submit

November 8, 2012

Conditions

Genital Human Papilloma Virus Infection

Keywords

HPVcervix

Outcome Measures

Primary Outcomes (1)

  • Efficacy comparison number of patients with drop (min 2 Log units) in HPV specific viral load AV2-DM versus placebo

    90 days

Secondary Outcomes (1)

  • number of adverse vents AV2-DM versus placebo

    90 days

Study Arms (2)

olive oil with 10% d-limonene

PLACEBO COMPARATOR

Topical spray one-time administration 2 puffs of 100µl

Drug: topical spray on the cervixProcedure: cervical swab with Cervex-Brush-Combi at T0Procedure: cervical swab with Cervex-Brush-Combi at T1

AV2-DM antiviral spray

EXPERIMENTAL

Topical spray one-time application 2 puffs of 100µl

Drug: topical application cervical sprayProcedure: cervical swab with Cervex-Brush-Combi at T0Procedure: cervical swab with Cervex-Brush-Combi at T1

Interventions

topical application cervical sprayDRUG

one time (2 puffs) topical application of 100µl AV2-DM antiviral spray( containing 50% AV2-DM and 50% olive oil)on the cervix

AV2-DM antiviral spray
topical spray on the cervixDRUG

one time (2 puffs) topical spray of 100 µl (90% olive oil and 10% d-limonene) on the cervix

olive oil with 10% d-limonene
cervical swab with Cervex-Brush-Combi at T0PROCEDURE
AV2-DM antiviral spray
cervical swab with Cervex-Brush-Combi at T1PROCEDURE
AV2-DM antiviral spray

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Labo Riatol

Antwerp, Antwerpen, 2020, Belgium

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2012

First Posted

August 1, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

November 9, 2012

Record last verified: 2012-11

Locations

BE(1)