Impact of AV2 Antiviral Drug on the Treatment of HPV-associated Lesions of the Uterine Cervix (KINVAV)
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|ClinicalTrials.gov Identifier: NCT02346227|
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : October 12, 2018
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Introduction Cervical cancer (CC) is a major public health problem in Low-income countries (LICs), particularly in the Democratic Republic of the Congo (DRC), where the estimated number of cases is 3839 per year. (WHO, 2010).
Persistent infection with Human Papillomavirus (HPV) is recognized as the necessary cause for the development of CC. Thus, CC is a disease that is easily preventable primarily by vaccination against HPV and secondarily through screening and treatment of precancerous lesions of the cervix.
In LICs, the high incidence of CC is due to both high rates of infection with HPV, a failure to initiate and sustain effective screening programs based on cytology and the non-availability of vaccination against HPV. These situations highlight the need to implement simple and inexpensive screening and treatment methods suitable for LICs. These methods include screening by visual inspection of the cervix after application of acetic acid (VIA) and treatment with a topical antiviral drug (AV2).
This study aims to:
- Evaluate the clinical efficacy of AV2 as a treatment for HPV-associated lesions of the uterine cervix;
- Identify HPV genotypes found in Kinshasa;
- Determine the cost-effectiveness of an algorithm combining screening by VIA and AV2 and that combining VIA and cryotherapy treatment;
- Methods After basic training of local health workers on VIA, on collection of cervical samples for HPV testing (quantitative Polymerase Chain reaction, qPCR) and liquid-based cytology (LBC) and on application of AV2, a screening and treatment program will be offered to women aged 25 and older who will give their informed consent.
All women with lesions on VIA will be randomized into one of two groups to receive either treatment by AV2 or placebo.
All women with lesions on VIA will be monitored and reviewed after two months and after six months for repeat tests (VIA and LBC for lesions, qPCR for viral load, conversion and reinfection rates).
|Condition or disease||Intervention/treatment||Phase|
|Uterine Cervical Dysplasia Papillomavirus Infections||Drug: AV2 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||327 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||August 2018|
|Actual Study Completion Date :||August 2018|
Active Comparator: AV2
Drug: application of topical spray on the cervix one time (2 puffs) topical application of 100µl AV2 antiviral spray( natural essential oil components in equal volumes diluted 50% in olive oil)
The virucide AV2 consists of a spray. It is a mixture of natural essential oil components (Carvone, Eugenol, Geraniol, Nerolidol) in equal volumes diluted 50% in olive oil (Olea europaea).
It is administered as a topical spray to the cervix while the subject is in the lithotomic position and fitted with a speculum. The manual spray applicator is positioned inside the anterior of the vagina and two pumps are applied. Each pump delivers 100 microliters of the solution.
Other Name: Antivirus 2
Placebo Comparator: Placebo
Drug: application of topical spray on the cervix one time (2 puffs) topical spray of 100 µl on the cervix.
The placebo consists of 10% lemon (citrus limon) and 10% lime (citrus aurantifolia) in 80% olive oil.
It is administered as a one time (2 puffs) topical spray of 100 microliters on the cervix.
Other Name: lemon, lime & olive oil.
- Change of lesions [ Time Frame: 2 months ]
lesion size" on a scale of 0 - 1 - 2: 0 : for a lesion < 5 mm
- : for a lesion 5-15 mm or involving 2 quadrants of the cervix
- : for a lesion > 15 mm or involving 3-4 quadrants or endocervically undefined.
- absence of HPV DNA [ Time Frame: 2 months ]copies/cell
- correlation between change of lesions and change in HPV DNA [ Time Frame: 2 months ]
0 : for a lesion < 5 mm
- : for a lesion 5-15 mm or involving 2 quadrants of the cervix
- : for a lesion > 15 mm or involving 3-4 quadrants or endocervically undefined. Copies/cell for HPV DNA
- Change in HPV viral particle load [ Time Frame: 6 months ]copies/cell
- number of patients with adverse effects [ Time Frame: 2 months ]Measure of Safety and Tolerability
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|Ages Eligible for Study:||25 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- Sexually-active women
- Women with intact uterine cervix
- Voluntary written informed consent to participate in the study
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346227
|Congo, The Democratic Republic of the|
|Centre de Santé Lisungi|
|Kinshasa, Mont-Ngafula, Congo, The Democratic Republic of the, Route Kimwenza n°23|
|Study Director:||Yves Jacquemyn, MD PhD||University Hospital, Antwerp|
|Principal Investigator:||Alex Mutombo Baleka, MD||University of Kinshasa|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Jean-Pierre Van geertruyden, Prof, Universiteit Antwerpen|
|Other Study ID Numbers:||
|First Posted:||January 26, 2015 Key Record Dates|
|Last Update Posted:||October 12, 2018|
|Last Verified:||October 2018|
Uterine Cervical Dysplasia
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
DNA Virus Infections
Tumor Virus Infections
Uterine Cervical Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications