HPV related pre cancerous lesions of the cervix Cancer Cervical cancer
Conditions
Interventions
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 ce
Sponsors
University of Manchester (UK)
Eligibility
Sex/Gender
Female
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Kenya
Outcome results
None listed