Cryotherapy vs. LEEP to Treat CIN2/3 Among HIV-positive Women (PHE-LEEP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Washington
Sponsor:
Collaborators:
University of Nairobi
International Agency for Research on Cancer
Information provided by (Responsible Party):
Michael Chung, University of Washington
ClinicalTrials.gov Identifier:
NCT01298596
First received: February 16, 2011
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Cervical Intraepithelial Neoplasia
Procedure: Loop Electrosurgical Excision Procedure (LEEP)
Procedure: Cryotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Cryotherapy Versus Loop Electrosurgical Excision Procedure (LEEP) on Recurrence of Cervical Intraepithelial Neoplasia and HIV-1 Cervical Shedding Among HIV-positive Women

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • recurrence of cervical intraepithelial neoplasia among HIV-positive women [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Rate of recurrence of cervical intraepithelial neoplasia among HIV-positive women receiving cryotherapy versus LEEP over 2 years of follow-up


Secondary Outcome Measures:
  • Shedding of HIV-1 from the cervix between HIV-positive women [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Shedding of HIV-1 from the cervix between HIV-positive women receiving cryotherapy versus LEEP over 6 weeks of follow-up


Estimated Enrollment: 400
Study Start Date: June 2011
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cryotherapy
Cryotherapy procedure which will freeze and remove the diseased part of the cervix
Procedure: Cryotherapy
Cryotherapy procedure which will freeze and remove the diseased part of the cervix
Experimental: Loop Electrosurgical Excision Procedure (LEEP)
LEEP procedure uses a heated wire to scoop out disease from the cervix
Procedure: Loop Electrosurgical Excision Procedure (LEEP)
LEEP procedure uses a heated wire to scoop out disease from the cervix
Other Name: LEEP

Detailed Description:

The recent scale-up of antiretroviral treatment programs in resource-limited settings provides an unprecedented opportunity to implement a comprehensive cervical cancer screening and treatment program for women who, by virtue of having HIV, are at significant risk for cervical disease. Unfortunately, even if screening is offered free of charge to millions of women living with HIV, it is unclear which treatment modality for pre-cancerous cervical lesions will be most effective since HIV appears to affect outcomes of treatment by increasing the recurrence and severity of cervical disease. Cervical treatment may also increase shedding of HIV from the cervix which may put discordant couples at risk and possibly spread HIV more widely. This study proposes to randomize HIV-positive women with cervical intraepithelial neoplasia grade 2 and 3 (CIN 2 and 3) to cryotherapy vs. loop electrosurgical excision procedure (LEEP) and measure the recurrence of cervical disease in each group over 2-years of follow-up as well as HIV shedding from the cervix for 6 weeks after treatment.

Our hypothesis is that compared to cryotherapy, LEEP is significantly more likely to prevent recurrence of cervical lesions over 2 years of follow-up and less likely to cause shedding of HIV-1 from the cervix over 3 weeks of follow-up.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV positive receiving care at the Coptic Hope Center
  • Not pregnant by clinical examination or history
  • Have an intact cervix
  • Have not received prior cervical treatment
  • Do not have a history of a bleeding disorder
  • Are above 18 years of age

Exclusion Criteria:

  • HIV-negative
  • Male
  • Below 18 years of age
  • Pregnant by clinical examination or history
  • Post-hysterectomy
  • Post-cervical cancer treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298596

Locations
Kenya
Coptic Hospital Recruiting
Nairobi, Kenya, 21570-00505
Contact: Dr. Nelly Yatich       yatich@u.washington.edu   
Sponsors and Collaborators
University of Washington
University of Nairobi
International Agency for Research on Cancer
Investigators
Principal Investigator: Michael Chung, MD University of Washington
  More Information

No publications provided

Responsible Party: Michael Chung, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01298596     History of Changes
Other Study ID Numbers: 35995-A, KE.09.0238
Study First Received: February 16, 2011
Last Updated: May 20, 2014
Health Authority: Kenya: Ethical Review Committee
United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
HIV Seropositivity
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 31, 2014