AV2 Antiviral Spray Versus Placebo in Human Papillomavirus Cervix Infections
This trial is active, not recruiting.
|Condition||genital human papilloma virus infection|
|Treatments||topical application cervical spray, topical spray on the cervix, cervical swab with cervex-brush-combi at t0, cervical swab with cervex-brush-combi at t1|
|Sponsor||Cesa Projects International|
|Start date||August 2012|
|End date||December 2012|
|Trial size||100 participants|
|Trial identifier||NCT01654822, AV2-HPV-001|
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
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Efficacy comparison number of patients with drop (min 2 Log units) in HPV specific viral load AV2-DM versus placebo
time frame: 90 days
number of adverse vents AV2-DM versus placebo
time frame: 90 days
Female participants from 25 years up to 40 years old.
- 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.
- 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.
|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|
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