AV2 Antiviral Spray Versus Placebo in Human Papillomavirus Cervix Infections
NCT ID: NCT01654822
Last Updated: 2012-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2012-08-31
2013-01-31
Brief Summary
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* Primary endpoint: significant drop in viral load AV2-DM versus placebo
* Secondary endpoint:the number of patients with adverse events
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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olive oil with 10% d-limonene
Topical spray one-time administration 2 puffs of 100µl
topical spray on the cervix
one time (2 puffs) topical spray of 100 µl (90% olive oil and 10% d-limonene) on the cervix
cervical swab with Cervex-Brush-Combi at T0
cervical swab with Cervex-Brush-Combi at T1
AV2-DM antiviral spray
Topical spray one-time application 2 puffs of 100µl
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
cervical swab with Cervex-Brush-Combi at T0
cervical swab with Cervex-Brush-Combi at T1
Interventions
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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
topical spray on the cervix
one time (2 puffs) topical spray of 100 µl (90% olive oil and 10% d-limonene) on the cervix
cervical swab with Cervex-Brush-Combi at T0
cervical swab with Cervex-Brush-Combi at T1
cervical swab with Cervex-Brush-Combi at T0
cervical swab with Cervex-Brush-Combi at T1
Eligibility Criteria
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Inclusion Criteria
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
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.
25 Years
40 Years
FEMALE
No
Sponsors
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Cesa Projects International
INDUSTRY
Responsible Party
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Locations
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Labo Riatol
Antwerp, Antwerpen, Belgium
Countries
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Other Identifiers
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AV2-HPV-001
Identifier Type: -
Identifier Source: org_study_id