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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02346227 |
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Date of registration:
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08/11/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Impact of AV2 Antiviral Drug on the Treatment of HPV-associated Lesions of the Uterine Cervix
KINVAV |
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Scientific title:
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Efficiency of AV2 Antiviral Drug in the Treatment of Human Papillomavirus-associated Precancerous Lesions of the Uterine Cervix: a Randomized Clinical Trial in Kinshasa, Democratic Republic of the Congo |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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327 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02346227 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Congo
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Congo, The Democratic Republic of the
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Contacts
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Name:
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Yves Jacquemyn, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Antwerp |
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Name:
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Alex Mutombo Baleka, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Kinshasa |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Sexually-active women
- Women with intact uterine cervix
- Voluntary written informed consent to participate in the study
Exclusion Criteria:
- Virgin women
- Pregnant or breast-feeding women, and women in the post-partum period
- Subject is already diagnosed with cervical cancer
- Medical history of any severe diseases like hepatitis, renal or liver dysfunction,
cardiovascular, gastrointestinal, malignant tumor, 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 or
its components (olive oil or d-limonene)
- Inability to follow the study protocol
Age minimum:
25 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Papillomavirus Infections
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Uterine Cervical Dysplasia
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Intervention(s)
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Drug: AV2
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Drug: Placebo
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Primary Outcome(s)
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Change of lesions
[Time Frame: 2 months]
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Secondary Outcome(s)
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absence of HPV DNA
[Time Frame: 2 months]
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Change in HPV viral particle load
[Time Frame: 6 months]
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correlation between change of lesions and change in HPV DNA
[Time Frame: 2 months]
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Secondary ID(s)
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UA-IHU- 2012-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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