Extrait

Background and study aims Cancer of cervix is the second leading cause of cancer deaths in women worldwide. Global estimates suggest that there are 452,000 new cases and more than 270,000 deaths every year. The number of cervical cancer cases, along with HIV/AIDS, are of particular concern in developing countries, such as Kenya. Cervical cancer is the leading cause of cancer-related deaths among women in developing countries. It is the most common cancer of the female reproductive system in Kenya. We have shown in our previous research that the main active component of the drug Lopimune(CIPLA, India) Lopinavir, usually given as tablets to treat HIV infection may also be successful in treating human papilloma virus (HPV) infections. The aim of this study is to test the safety/tolerability of vaginally delivered Lopimune soft-gel capsules as a treatment for HPV mediated cervical disease in HIV negative patients and to also determine their effectiveness. Who can participate? HIV negative women aged >18years attending Kenyatta National Hospital's Family Planning Clinic and Gynaecology Out-patient Clinics in Nairobi, positive for the presence of high risk HPV and have been found upon cytological screening to have cervical abnormality (dysplasia). What does the study involve? Participants will be randomly allocated to oine of two groups: either once daily or twice daily Lopimune (self applied as a pessary) for a period of 2 weeks. The effects of these treatments will be analysed during follow-up which includes colposcopic examination, repeat smear and HPV testing followed by a final punch biopsy. What are the possible benefits and risks of participating? Benefits - All those undergoing the initial screening will benefit from: Free counselling and HIV testing; Prompt referral for HIV disease relevant treatment and long-term follow-up; HPV testing; Standard pap smear and liquid based cytology smear ; Sexually transmitted disease screening and treatment if needed; Full blood count; Urea and electrolytes; Liver function tests; Transport costs to and from clinic. Any women found to have invasive cervical cancer will receive immediate treatment paid for by the study. Those who go onto be enrolled into the study will also benefit from continued follow up until 3 months post Lopimune application and, if needed, at the end of the 3 months further ongoing standard care treatment (loop excision). Any potential risks from this study would be as a result of the effects of Lopimune exposure on the vaginal and cervical tissue (e.g. vaginitis, cervicitis, dryness, itching etc) and systemic side effects as documented for oral Lopinivir. Where is the study run from? The study will be carried out at Kenyatta National Hospital in Nairobi. Manchester University, UK will be responsible for some aspects of the diagnostic work and all the scientific aspects, which require access to specialist equipment. When is study starting and how long is it expected to run for? From April 2013 to April 2014 Who is funding the study? Cancer Research Trust Kenya and the Caring Cancer Trust UK. Who is the main contact? Dr Ian Hampson, Reader in Viral Oncology, [email protected] Dr Lynne Hampson, [email protected]

Critère d'inclusion

• HPV related pre cancerous lesions of the cervix

Liens

• isrctn
• ictrp