Trial | NCT01654822  Report issue

Title

AV2 Antiviral Spray Versus Placebo in Human Papillomavirus Cervix Infections
Single Center, Placebo Controlled, Double-Blind Study to the Treatment of HPV Infected Cervix With AV2 Antiviral Spray and Assessment of Viral Load

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    av2-dm d-limonene olive ...

  • Study Participants

    100
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
Study Started
Aug 31
2012
Primary Completion
Dec 31
2012
Anticipated
Study Completion
Jan 31
2013
Anticipated
Last Update
Nov 09
2012
Estimate

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

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

Procedure cervical swab with Cervex-Brush-Combi at T0

Procedure cervical swab with Cervex-Brush-Combi at T1

olive oil with 10% d-limonene Placebo Comparator

Topical spray one-time administration 2 puffs of 100µl

AV2-DM antiviral spray Experimental

Topical spray one-time application 2 puffs of 100µl

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.
No Results Posted