Promotors

  • Yves Jacquemyn, University of Antwerp

  • Jean-Pierre Van geertruyden, University of Antwerp

  • Rahma Tozin, University of Kinshasa

Efficiency of AV2® antiviral drug in the treatment of Human Papillomavirus-associated precancerous lesions of the uterine cervix: a randomized placebo-controlled clinical trial in Kinshasa, Democratic Republic of the Congo

This study aims to evaluate the clinical efficacy of AV2 antiviral drug as a treatment for HPV-associated lesions of the uterine cervix; to Identify HPV genotypes found in Kinshasa and to determine the cost-effectiveness of an algorithm combining screening by VIA and AV2 and that combining VIA and cryotherapy treatment;After basic training of local health workers on VIA, on collection of cervical samples for HPV testing 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, LBC, HPV testing).

The study has been approved by both the Ethics Committees of the University of Antwerp and of the University of Kinshasa, and is registered with ClinicalTrials.gov under identifier NCT02346227.