Clinical trial NCT01654822: AV2 Antiviral Spray Versus Placebo in Human Papillomavirus Cervix Infections
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Genital Human Papilloma Virus Infection
Keywords: HPV
cervix
Lead sponsor: Cesa Projects International
Sponsor class: INDUSTRY
First posted: 2012-08-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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 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.

Primary outcomes:
measure: Efficacy comparison number of patients with drop (min 2 Log units) in HPV specific viral load AV2-DM versus placebo
timeFrame: 90 days
Secondary outcomes:
measure: number of adverse vents AV2-DM versus placebo
timeFrame: 90 days
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Labo Riatol
Study officials:
References: