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Cryotherapy vs. LEEP to Treat Cervical Intraepithelial Neoplasia (CIN) 2/3 Among HIV-positive Women

NCT01298596 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2019-11-12

Study results available
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Summary

The purpose of this study is to compare the rate of recurrence of cervical intraepithelial neoplasia among HIV-positive women receiving cryotherapy versus LEEP over 2 years of follow-up and to compare the shedding of HIV-1 from the cervix between HIV-positive women receiving cryotherapy versus LEEP over 3 weeks of follow-up.

Conditions

  • Cervical Intraepithelial Neoplasia

Interventions

PROCEDURE

Loop Electrosurgical Excision Procedure (LEEP)

LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix

PROCEDURE

Cryotherapy

Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix

Sponsors & Collaborators

  • University of Nairobi

    collaborator OTHER

  • International Agency for Research on Cancer

    collaborator OTHER

  • University of Washington

    lead OTHER

Principal Investigators

  • Michael Chung, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2016-10-31
Completion
2017-01-31

Countries

  • Kenya

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01298596 on ClinicalTrials.gov