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)
| Autor: | Rahma Tozin, Cindy Simoens, Jean-Pierre Van Geertruyden, Johannes Bogers, Ramokone Lisbeth, Alex Baleka Mutombo, Yves Jacquemyn |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Human papillomavirus medicine.medical_specialty medicine.drug_class medicine.medical_treatment Cryotherapy Placebo Article law.invention 03 medical and health sciences Precancerous lesions 0302 clinical medicine Randomized controlled trial law Internal medicine Cytology Uterine cervix medicine Antiviral Cervix Pharmacology Gynecology Cervical cancer lcsh:R5-920 business.industry General Medicine medicine.disease Clinical trial 030104 developmental biology medicine.anatomical_structure 030220 oncology & carcinogenesis Democratic Republic of the Congo Human medicine Randomized clinical trial Antiviral drug lcsh:Medicine (General) business |
| Zdroj: | Contemporary Clinical Trials Communications Contemporary Clinical Trials Communications, Vol 8, Iss C, Pp 135-139 (2017) |
| ISSN: | 2451-8654 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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