Efficacy of antiviral drug AV2 in the treatment of human papillomavirus-associated precancerous lesions of the uterine cervix: A randomized placebo-controlled clinical trial in Kinshasa, DR Congo. (KINVAV study)
Background: Cervical Cancer (CC) is a major public health problem in DR Congo; the high incidence of CC is due to the inexistence of effective screening programs based on cytology and/or HPV detection followed by appropriate treatments. This situation highlights the need to implement efficacious and...
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| Format: | Article |
| Language: | English |
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Elsevier
2017-12-01
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| Series: | Contemporary Clinical Trials Communications |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865417300613 |
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| author | Alex Baleka Mutombo Rahma Tozin Cindy Simoens Ramokone Lisbeth Johannes Bogers Jean-Pierre Van Geertruyden Yves Jacquemyn |
| author_facet | Alex Baleka Mutombo Rahma Tozin Cindy Simoens Ramokone Lisbeth Johannes Bogers Jean-Pierre Van Geertruyden Yves Jacquemyn |
| author_sort | Alex Baleka Mutombo |
| collection | DOAJ |
| description | Background: Cervical Cancer (CC) is a major public health problem in DR Congo; the high incidence of CC is due to the inexistence of effective screening programs based on cytology and/or HPV detection followed by appropriate treatments. This situation highlights the need to implement efficacious and inexpensive treatment methods. This study aims at evaluating the efficacy of a topical antiviral drug named AV2® as a treatment for HPV-associated lesions of the cervix.
Methods: Women will undergo cytology sampling, HPV testing and Visual inspection of the cervix after application of 5% acetic acid (VIA). VIA-positive women will be randomized to one of two groups to receive treatment by either AV2®or placebo. They will undergo control examinations after two months and after six months. In case of persistent lesions on VIA, treatment by cryotherapy will be done. The primary outcomes will be the change of lesions, the clearance of HPV DNA, and the correlation of the two 2 months after treatment with AV2®.
Conclusion: This study is the first large-scale study in Africa to evaluate systematically the efficacy and safety of a topical antiviral drug for the treatment of HPV associated lesions of the cervix. Its findings will direct the planning of suitable algorithms for CC screening and treatment.
Clinical trial registration: ClinicalTrials.gov – Unique identifier: NCT02346227, registered on November 8, 2014. |
| first_indexed | 2024-04-14T01:34:52Z |
| format | Article |
| id | doaj.art-887dbe4c218d4c84a5ec85043446ba55 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-04-14T01:34:52Z |
| publishDate | 2017-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-887dbe4c218d4c84a5ec85043446ba552022-12-22T02:20:01ZengElsevierContemporary Clinical Trials Communications2451-86542017-12-018C13513910.1016/j.conctc.2017.09.008Efficacy of antiviral drug AV2 in the treatment of human papillomavirus-associated precancerous lesions of the uterine cervix: A randomized placebo-controlled clinical trial in Kinshasa, DR Congo. (KINVAV study)Alex Baleka Mutombo0Rahma Tozin1Cindy Simoens2Ramokone Lisbeth3Johannes Bogers4Jean-Pierre Van Geertruyden5Yves Jacquemyn6Department of Obstetrics and Gynecology, Kinshasa University Hospital, Kinshasa, Democratic Republic of the CongoDepartment of Obstetrics and Gynecology, Kinshasa University Hospital, Kinshasa, Democratic Republic of the CongoApplied Molecular Biology Research Group (AMBIOR), Faculty of Medicine and Health Sciences, University of Antwerp, Universiteitsplein 1, 2610, Wilrijk, BelgiumHIV and Hepatitis Research Unit, Department of Virology, Sefako Makgatho Health Science University, Pretoria, South AfricaApplied Molecular Biology Research Group (AMBIOR), Faculty of Medicine and Health Sciences, University of Antwerp, Universiteitsplein 1, 2610, Wilrijk, BelgiumGlobal Health Institute, Faculty of Medicine & Health Sciences, University of Antwerp, Doornstraat 331, BE-2610, Wilrijk, BelgiumDepartment of Obstetrics and Gynaecology, UZA Antwerp University Hospital, Wilrijkstraat 10, 2650, Edegem, BelgiumBackground: Cervical Cancer (CC) is a major public health problem in DR Congo; the high incidence of CC is due to the inexistence of effective screening programs based on cytology and/or HPV detection followed by appropriate treatments. This situation highlights the need to implement efficacious and inexpensive treatment methods. This study aims at evaluating the efficacy of a topical antiviral drug named AV2® as a treatment for HPV-associated lesions of the cervix. Methods: Women will undergo cytology sampling, HPV testing and Visual inspection of the cervix after application of 5% acetic acid (VIA). VIA-positive women will be randomized to one of two groups to receive treatment by either AV2®or placebo. They will undergo control examinations after two months and after six months. In case of persistent lesions on VIA, treatment by cryotherapy will be done. The primary outcomes will be the change of lesions, the clearance of HPV DNA, and the correlation of the two 2 months after treatment with AV2®. Conclusion: This study is the first large-scale study in Africa to evaluate systematically the efficacy and safety of a topical antiviral drug for the treatment of HPV associated lesions of the cervix. Its findings will direct the planning of suitable algorithms for CC screening and treatment. Clinical trial registration: ClinicalTrials.gov – Unique identifier: NCT02346227, registered on November 8, 2014.http://www.sciencedirect.com/science/article/pii/S2451865417300613Human papillomavirusPrecancerous lesionsUterine cervixAntiviralRandomized clinical trialDemocratic Republic of the Congo |
| spellingShingle | Alex Baleka Mutombo Rahma Tozin Cindy Simoens Ramokone Lisbeth Johannes Bogers Jean-Pierre Van Geertruyden Yves Jacquemyn Efficacy of antiviral drug AV2 in the treatment of human papillomavirus-associated precancerous lesions of the uterine cervix: A randomized placebo-controlled clinical trial in Kinshasa, DR Congo. (KINVAV study) Contemporary Clinical Trials Communications Human papillomavirus Precancerous lesions Uterine cervix Antiviral Randomized clinical trial Democratic Republic of the Congo |
| title | Efficacy of antiviral drug AV2 in the treatment of human papillomavirus-associated precancerous lesions of the uterine cervix: A randomized placebo-controlled clinical trial in Kinshasa, DR Congo. (KINVAV study) |
| title_full | Efficacy of antiviral drug AV2 in the treatment of human papillomavirus-associated precancerous lesions of the uterine cervix: A randomized placebo-controlled clinical trial in Kinshasa, DR Congo. (KINVAV study) |
| title_fullStr | Efficacy of antiviral drug AV2 in the treatment of human papillomavirus-associated precancerous lesions of the uterine cervix: A randomized placebo-controlled clinical trial in Kinshasa, DR Congo. (KINVAV study) |
| title_full_unstemmed | Efficacy of antiviral drug AV2 in the treatment of human papillomavirus-associated precancerous lesions of the uterine cervix: A randomized placebo-controlled clinical trial in Kinshasa, DR Congo. (KINVAV study) |
| title_short | Efficacy of antiviral drug AV2 in the treatment of human papillomavirus-associated precancerous lesions of the uterine cervix: A randomized placebo-controlled clinical trial in Kinshasa, DR Congo. (KINVAV study) |
| title_sort | efficacy of antiviral drug av2 in the treatment of human papillomavirus associated precancerous lesions of the uterine cervix a randomized placebo controlled clinical trial in kinshasa dr congo kinvav study |
| topic | Human papillomavirus Precancerous lesions Uterine cervix Antiviral Randomized clinical trial Democratic Republic of the Congo |
| url | http://www.sciencedirect.com/science/article/pii/S2451865417300613 |
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