Impact of AV2 Antiviral Drug on the Treatment of HPV-associated Lesions of the Uterine Cervix
Status:
Completed
Trial end date:
2018-08-01
Target enrollment:
Participant gender:
Summary
1. 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).
2. Aims
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;
3. 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).
Phase:
Phase 3
Details
Lead Sponsor:
Jean-Pierre Van geertruyden
Collaborators:
University Hospital, Antwerp University of Kinshasa