Impact of AV2 Antiviral Drug on the Treatment of HPV-associated Lesions of the Uterine Cervix

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).

Conditions

• Uterine Cervical Dysplasia
• Papillomavirus Infections

Interventions

DRUG

AV2

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.

DRUG

Placebo

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.

Sponsors & Collaborators

• University of Kinshasa

  collaborator OTHER

• University Hospital, Antwerp

  collaborator OTHER

• Jean-Pierre Van geertruyden

  lead OTHER

Principal Investigators

• Yves Jacquemyn, MD PhD · University Hospital, Antwerp

• Alex Mutombo Baleka, MD · University of Kinshasa

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SINGLE_GROUP

Eligibility

Min Age

25 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2018-08-31

Completion

2018-08-31

Countries

• Democratic Republic of the Congo

Study Locations