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

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ClinicalTrials.gov Identifier: NCT01298596
Recruitment Status : Completed
First Posted : February 17, 2011
Results First Posted : October 18, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborators:
University of Nairobi
International Agency for Research on Cancer
Information provided by (Responsible Party):
Michael Chung, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cervical Intraepithelial Neoplasia
Interventions Procedure: Loop Electrosurgical Excision Procedure (LEEP)
Procedure: Cryotherapy
Enrollment 400
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cryotherapy Loop Electrosurgical Excision Procedure
Hide Arm/Group Description

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

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

Loop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix

Loop Electrosurgical Excision Procedure (LEEP): LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix

Period Title: Overall Study
Started 200 200
Completed 172 167
Not Completed 28 33
Reason Not Completed
Withdrawal by Subject             1             1
Death             5             3
Lost to Follow-up             6             14
Referred for further management             16             15
Arm/Group Title Cryotherapy Loop Electrosurgical Excision Procedure Total
Hide Arm/Group Description

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

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

Loop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix

Loop Electrosurgical Excision Procedure (LEEP): LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix

Total of all reporting groups
Overall Number of Baseline Participants 200 200 400
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 189 participants 383 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
194
 100.0%
189
 100.0%
383
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Not all women provided age or a date of birth at baseline
Age, Continuous   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 194 participants 189 participants 383 participants
38.2
(32.0 to 42.5)
37.4
(31.7 to 44.9)
37.4
(31.7 to 43.8)
[1]
Measure Analysis Population Description: Not all women provided age or a date of birth at baseline
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 200 participants 400 participants
Female
200
 100.0%
200
 100.0%
400
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Kenya Number Analyzed 200 participants 200 participants 400 participants
200
 100.0%
200
 100.0%
400
 100.0%
Previously screened for cervical cancer   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 189 participants 189 participants 378 participants
65
  34.4%
55
  29.1%
120
  31.7%
[1]
Measure Analysis Population Description: Some women were uncertain of prior screening status
1.Primary Outcome
Title Recurrence of Cervical Intraepithelial Neoplasia Among HIV-positive Women
Hide Description Rate of recurrence of cervical intraepithelial neoplasia among HIV-positive women receiving cryotherapy versus LEEP over 2 years of follow-up
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cryotherapy Loop Electrosurgical Excision Procedure
Hide Arm/Group Description:

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

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

Loop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix

Loop Electrosurgical Excision Procedure (LEEP): LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix

Overall Number of Participants Analyzed 200 200
Measure Type: Count of Participants
Unit of Measure: Participants
60
  30.0%
37
  18.5%
2.Secondary Outcome
Title Shedding of HIV-1 From the Cervix Between HIV-positive Women
Hide Description Shedding of HIV-1 from the cervix between HIV-positive women receiving cryotherapy versus LEEP between baseline and weeks 1, 2, and 3 of follow-up
Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cryotherapy Loop Electrosurgical Excision Procedure
Hide Arm/Group Description:

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

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

Loop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix

Loop Electrosurgical Excision Procedure (LEEP): LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix

Overall Number of Participants Analyzed 200 200
Mean (95% Confidence Interval)
Unit of Measure: change in log10 cps HIV RNA per swab
Baseline and Week 1
-0.02
(-0.11 to 0.06)
0.10
(0.02 to 0.18)
Baseline and Week 2
0.07
(-0.02 to 0.16)
0.25
(0.14 to 0.37)
Baseline and Week 3
0.05
(-0.05 to 0.14)
0.26
(0.14 to 0.38)
Time Frame 24 months
Adverse Event Reporting Description

We used Division of AIDS Table for Grading the Severity of Adult Adverse Events version 1.0.

Adverse Events were monitored/assessed without regard to the specific Adverse Event Term

 
Arm/Group Title Cryotherapy Loop Electrosurgical Excision Procedure
Hide Arm/Group Description

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

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

Loop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix

Loop Electrosurgical Excision Procedure (LEEP): LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix

All-Cause Mortality
Cryotherapy Loop Electrosurgical Excision Procedure
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Cryotherapy Loop Electrosurgical Excision Procedure
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/200 (2.50%)      2/200 (1.00%)    
Infections and infestations     
HIV complications *  5/200 (2.50%)  5 2/200 (1.00%)  2
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cryotherapy Loop Electrosurgical Excision Procedure
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/200 (1.00%)      0/200 (0.00%)    
Surgical and medical procedures     
Related to procedure * [1]  2/200 (1.00%)  2 0/200 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
post-operative bleeding
1) Conducted in a single center with one clinician administering all procedures 2) Human papillomavirus-type specific results not available 3) HIV factors vary with time 4) Longer follow-up is necessary 5) Imbalance in cervical HIV RNA at baseline
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michael H. Chung
Organization: University of Washington
Phone: ‭(206) 302-8361‬
EMail: mhchung@uw.edu
Layout table for additonal information
Responsible Party: Michael Chung, University of Washington
ClinicalTrials.gov Identifier: NCT01298596    
Other Study ID Numbers: 35995-J
KE.09.0238 ( Other Identifier: Kenya Ethical Review Committee )
First Submitted: February 16, 2011
First Posted: February 17, 2011
Results First Submitted: September 23, 2019
Results First Posted: October 18, 2019
Last Update Posted: November 12, 2019