Evaluation of a new self applied treatment for early stage pre cancerous disease of the cervix

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN48776874
• Date of registration: 29/05/2014
• Prospective Registration: No
• Primary sponsor: University of Manchester (UK)
• Public title: Evaluation of a new self applied treatment for early stage pre cancerous disease of the cervix
• Scientific title: Lopinavir as a Topical Treatment (LOTT) trial for HPV-related cervical dysplasia in HIV negative women
• Date of first enrolment: 01/04/2013
• Target sample size: 40
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN48776874
• Study type: Interventional
• Study design: Non-randomised Interventional Design type: Treatment (Treatment)
• Phase: Not Applicable

Countries of recruitment

Kenya

Contacts

• Name: Ian Hampson

Key inclusion & exclusion criteria

Inclusion criteria: 1. Women aged above 18 years
2. Patients who freely agree to join the study after extensive information and counselling; must also give written informed consent
3. Patients must be able to receive and understand verbal and written information about the study
4. Patients ready and willing to comply with the study follow-up schedule
5. Women receiving Lopimune must be HPV positive and have evidence of cervical dysplasia
Exclusion criteria: 1. Patients under 18 yrs of age
2. Patients who don't fulfil the above inclusion criteria
3. Patients with conditions in which blood sampling may increase risk of complications eg sickle cell disease
4. Known HIV positive patients
5. Patients who?re too ill to give informed consent
6. Persons who it is concluded through clinical judgment by the investigator should not participate in the study e.g. anticipated poor study compliance
7. Patients who have had prior surgical procedures on the cervix eg cone biopsy, hysterectomies etc.
8. Patients with invasive cervical cancer or carcinoma in situ

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

HPV related pre cancerous lesions of the cervix
Cancer
Cervical cancer

Intervention(s)

The study will involve the screening of 600 - 800 women who will be given HIV, HPV and other STI screening. Approximately 30 women who are HIV negative, HPV positive and show evidence of high grade cervical dysplasia will be enrolled into the Lopimune treatment part of the trial.

As a result of the screening:
Any woman testing positive for HIV will be given appropriate counselling, treatment and ongoing follow up. These results will be available within 2 weeks. Women identified with STDs will be referred for appropriate treatment. Women identified with high risk HPV will be will be provided with further information and counselling. Women identified with invasive cervical cancer or cervical dysplasia will be sent for colposcopy. Immediate treatment will be given for those with invasive cancer.

Those women with cervical dysplasia will be offered enrolment into the Lopimune stage of the study. This will consist of 1 Lopimune capsule twice daily for 2 weeks. All women will be examined every 2 days for adverse reactions. At 1 month post treatment they will be given colposcopy and a repeat LBC and HPV test. At 3 months post treatment this will be as per 1 month follow up, but extended to include a punch biopsy for histological examination. Women who still show evidence of high grade cervical dysplasia will be treated
as per best practise (LEEP, loop excision of the lesion) and followed up appropriately

Primary Outcome(s)

Tolerability of Lopimune capsules administered as a pessary in the vagina. After administration of the drug the participants were seen in clinic every 48 hours.They were then asked about any side effects (e.g cervicitis, vulvitis, vaginitis, discharge, vaginal dryness, unusual local sensations such as burning, tingling and numbness and these were recorded on a questionnaire (case report form). This continued for the 2 week duration of the treatment.
Full blood counts and liver function tests were also assessed at 1 week and 2 weeks of treatment with a 2 week post treatment check as an addition.

Secondary Outcome(s)

Efficacy of Lopimune, as measured by clearance of HPV and resumption of normal cervical cytology/pathology. Participants have a baseline HPV test and cervical cytology screen. In addition they are examined by colposcope using visualisation of the cervix by iodine stain. This is repeated at 4 weeks (i.e 2 weeks post cessation of treatment and 3 months. In addition at the 3 month post treatment time point the participants also have a punch biopsy(s) taken for histology.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Cancer Research Trust (Kenya), Caring Cancer Trust (UK)