Interferon Alpha Therapy for Cervical CINI and HPV Infection

Mongolian National University of Medical Sciences

Status and phase: Completed; Phase 1

Conditions: HPV Infection; Cervical Dysplasia

Treatments: Drug: gel Interferon and interferon suppository arm; Drug: gel Interferon arm

Study type: Interventional

Funder types: Other

Identifiers

NCT06137950

MNUMS2021100701

Details and patient eligibility

About

Mongolia is a traditionally nomadic and population is scarce in rural areas. Thus, the medical care service is not sufficient. In 2000, Mongolian government has developed and implemented the millennium project in cooperation with WHO. During the years pap smear analysis of implemented in all rural areas and clinicians, lab technicians have been taught for the cervical cancer screening. However, the project has finished in 2015 and the rural and district hospitals has lost the trained professionals. Still the cervical cancer is in second place after liver cancer in women.

The purpose of the study is to identify the type of HPV genotype and to treat the HPV infection by local interferon α2b.

Materials and methods: HPV positive patients will be enrolled to the study. HPV genotype will be determined by the PCR in laboratory. Pap smear will be taken and staged by the CIN. Pathological tissue will be taken under colposcopy with acetic acid test. Follow up visit will be done on 10th, 30th days of the treatment.

At the end of 90th days of treatment, pap and histology test will be repeated and CIN regression or viral eradication will be evaluated.

Full description

The purpose of the study is to evaluate the efficacy of interferon treatment for HPV infection shedding and early CIN change.

Women aging from 20-40 years will be enrolled in the study. The treatment will be held in two arms. One arm will be administered only vaginal gel interferon treatment. The other arm will receive both vaginal gel interferon and rectal suppositories with interferon dosing 3,000,000 IU.

In the beginning of the study all patient will have cervical pap smear and HPV typing.

HPV testing will be done using real time PCR method to determine the subtype of HPV (16,18,31,33,35,39,45,51,52,56,59,68).

At the beginning and at the end of the study all patient will have histology test.

Histology test will be done Giemsa staining and evaluated by WHO 2014 classification of cervical histology including CINI, CINII, CINIII, cervical cancer in situ and further.

Pap smear will be evaluated by Bethesda classification. Immunohistology staining will be done on the cervical tissue using anti-CD3 and anti-CD19 to evaluate the B cell invasion into the cervix.

Enrollment: 60 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pap smear LSIL
• HPV infection positive
• No anti-viral treatment in 2 weeks before treatment

Exclusion criteria

• No consent has obtained
• Anti-viral treatment in 2 weeks
• Breastfeeding or pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Control

Active Comparator group

Description:

Interferon α2b gel treatment for 30 days.

Treatment:

Drug: gel Interferon arm

Treatment

Experimental group

Description:

Interferon α2b gel treatment for 30 days + Interferon α2b 3 MIU rectal suppository for 10 days

Treatment:

Drug: gel Interferon arm

Drug: gel Interferon and interferon suppository arm