Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
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: December 7, 2014
Last verified: December 2014

February 16, 2011
December 7, 2014
June 2011
November 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01298596 on ClinicalTrials.gov Archive Site
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
Shedding of HIV-1 from the cervix between HIV-positive women [ Time Frame: 6 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
Not Provided
Not Provided
 
Cryotherapy vs. LEEP to Treat Cervical Intraepithelial Neoplasia (CIN) 2/3 Among HIV-positive Women
Impact of Cryotherapy Versus Loop Electrosurgical Excision Procedure (LEEP) on Recurrence of Cervical Intraepithelial Neoplasia and HIV-1 Cervical Shedding Among HIV-positive Women

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cervical Intraepithelial Neoplasia
  • Procedure: Loop Electrosurgical Excision Procedure (LEEP)
    LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix
    Other Name: LEEP
  • Procedure: Cryotherapy
    Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix
  • Experimental: Cryotherapy
    Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix
    Intervention: Procedure: Cryotherapy
  • Experimental: Loop Electrosurgical Excision Procedure
    Loop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix
    Intervention: Procedure: Loop Electrosurgical Excision Procedure (LEEP)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
November 2016
November 2016   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT01298596
35995-A, KE.09.0238
Yes
Michael Chung, University of Washington
University of Washington
  • University of Nairobi
  • International Agency for Research on Cancer
Principal Investigator: Michael Chung, MD University of Washington
University of Washington
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP