Genital Human Papilloma Virus InfectionPhase 2NCT01654822
AV2 Antiviral Spray Versus Placebo in Human Papillomavirus Cervix Infections
A Phase 2 study testing topical application cervical spray, topical spray on the cervix and cervical swab with Cervex-Brush-Combi at T0 in people with Genital Human Papilloma Virus Infection, run by Cesa Projects International at 1 site in Belgium.
Trial 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 Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Genital Human Papilloma Virus Infection
- What is being tested?
- topical application cervical spray, topical spray on the cervix and cervical swab with Cervex-Brush-Combi at T0
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2012to Jan 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Genital Human Papilloma Virus Infection
- Being tested
- 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
- Keywords
- HPV, cervix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical application cervical sprayDrug
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 cervixDrug
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 T0Procedure or surgery
cervical swab with Cervex-Brush-Combi at T1Procedure or surgery
cervical swab with Cervex-Brush-Combi at T0Procedure or surgery
cervical swab with Cervex-Brush-Combi at T1Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| olive oil with 10% d-limonene | Placebo comparator | Topical spray one-time administration 2 puffs of 100µl Receives: Drug: topical spray on the cervix; Procedure: cervical swab with Cervex-Brush-Combi at T0; Procedure: cervical swab with Cervex-Brush-Combi at T1 |
| AV2-DM antiviral spray | Experimental | Topical spray one-time application 2 puffs of 100µl Receives: Drug: topical application cervical spray; Procedure: cervical swab with Cervex-Brush-Combi at T0; Procedure: cervical swab with Cervex-Brush-Combi at T1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy comparison number of patients with drop (min 2 Log units) in HPV specific viral load AV2-DM versus placebo
Measured: 90 days
Secondary outcomes (1)
number of adverse vents AV2-DM versus placebo
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital Human Papilloma Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cesa Projects International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654822
- Sponsor's protocol ID
- AV2-HPV-001
- Status last verified
- Nov 2012
- First submitted
- 19 Jun 2012
- Last updated
- 9 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01654822
- Acronym / sponsor ID
- AV2-HPV-001
- Conditions
- Genital Human Papilloma Virus Infection
- Keywords
- HPV, cervix
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cesa Projects InternationalIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 1 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| olive oil with 10% d-limonene | Placebo comparator | Drug: topical spray on the cervix, Procedure: cervical swab with Cervex-Brush-Combi at T0, Procedure: cervical swab with Cervex-Brush-Combi at T1Topical spray one-time administration 2 puffs of 100µl |
| AV2-DM antiviral spray | Experimental | Drug: topical application cervical spray, Procedure: cervical swab with Cervex-Brush-Combi at T0, Procedure: cervical swab with Cervex-Brush-Combi at T1Topical spray one-time application 2 puffs of 100µl |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topical application cervical sprayone time (2 puffs) topical application of 100µl AV2-DM antiviral spray( containing 50% AV2-DM and 50% olive oil)on the cervix | Drug | AV2-DM antiviral spray |
| topical spray on the cervixone time (2 puffs) topical spray of 100 µl (90% olive oil and 10% d-limonene) on the cervix | Drug | olive oil with 10% d-limonene |
| cervical swab with Cervex-Brush-Combi at T0 | Procedure or surgery | AV2-DM antiviral spray |
| cervical swab with Cervex-Brush-Combi at T1 | Procedure or surgery | AV2-DM antiviral spray |
| cervical swab with Cervex-Brush-Combi at T0 | Procedure or surgery | olive oil with 10% d-limonene |
| cervical swab with Cervex-Brush-Combi at T1 | Procedure or surgery | olive oil with 10% d-limonene |
Primary outcome
Efficacy comparison number of patients with drop (min 2 Log units) in HPV specific viral load AV2-DM versus placebo
Time frame: 90 days
1 secondary outcome
number of adverse vents AV2-DM versus placebo
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing topical application cervical spray, topical spray on the cervix and cervical swab with Cervex-Brush-Combi at T0 in people with Genital Human Papilloma Virus Infection, run by Cesa Projects International at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy comparison number of patients with drop (min 2 Log units) in HPV specific viral load AV2-DM versus placebo (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2012.