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