Trial Outcomes & Findings for Cryotherapy vs. LEEP to Treat Cervical Intraepithelial Neoplasia (CIN) 2/3 Among HIV-positive Women (NCT NCT01298596)

NCT ID: NCT01298596

Last Updated: 2019-11-12

Results Overview

Rate of recurrence of cervical intraepithelial neoplasia among HIV-positive women receiving cryotherapy versus LEEP over 2 years of follow-up

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 400 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2019-11-12

Participant Flow

Participant milestones

Measure	Cryotherapy 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 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 Study STARTED	200	200
Overall Study COMPLETED	172	167
Overall Study NOT COMPLETED	28	33

Reasons for withdrawal

Measure	Cryotherapy 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 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 Study Withdrawal by Subject	1	1
Overall Study Death	5	3
Overall Study Lost to Follow-up	6	14
Overall Study Referred for further management	16	15

Baseline Characteristics

Not all women provided age or a date of birth at baseline

Baseline characteristics by cohort

Measure	Cryotherapy n=200 Participants 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 n=200 Participants 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 n=400 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=194 Participants • Not all women provided age or a date of birth at baseline	0 Participants n=189 Participants • Not all women provided age or a date of birth at baseline	0 Participants n=383 Participants • Not all women provided age or a date of birth at baseline
Age, Categorical Between 18 and 65 years	194 Participants n=194 Participants • Not all women provided age or a date of birth at baseline	189 Participants n=189 Participants • Not all women provided age or a date of birth at baseline	383 Participants n=383 Participants • Not all women provided age or a date of birth at baseline
Age, Categorical >=65 years	0 Participants n=194 Participants • Not all women provided age or a date of birth at baseline	0 Participants n=189 Participants • Not all women provided age or a date of birth at baseline	0 Participants n=383 Participants • Not all women provided age or a date of birth at baseline
Age, Continuous	38.2 years n=194 Participants • Not all women provided age or a date of birth at baseline	37.4 years n=189 Participants • Not all women provided age or a date of birth at baseline	37.4 years n=383 Participants • Not all women provided age or a date of birth at baseline
Sex: Female, Male Female	200 Participants n=200 Participants	200 Participants n=200 Participants	400 Participants n=400 Participants
Sex: Female, Male Male	0 Participants n=200 Participants	0 Participants n=200 Participants	0 Participants n=400 Participants
Region of Enrollment Kenya	200 Participants n=200 Participants	200 Participants n=200 Participants	400 Participants n=400 Participants
Previously screened for cervical cancer	65 Participants n=189 Participants • Some women were uncertain of prior screening status	55 Participants n=189 Participants • Some women were uncertain of prior screening status	120 Participants n=378 Participants • Some women were uncertain of prior screening status

PRIMARY outcome

Timeframe: 2 years

Rate of recurrence of cervical intraepithelial neoplasia among HIV-positive women receiving cryotherapy versus LEEP over 2 years of follow-up

Outcome measures

Measure	Cryotherapy n=200 Participants 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 n=200 Participants 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
Recurrence of Cervical Intraepithelial Neoplasia Among HIV-positive Women	60 Participants	37 Participants

SECONDARY outcome

Timeframe: 3 weeks

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

Outcome measures

Measure	Cryotherapy n=200 Participants 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 n=200 Participants 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
Shedding of HIV-1 From the Cervix Between HIV-positive Women Baseline and Week 1	-0.02 change in log10 cps HIV RNA per swab Interval -0.11 to 0.06	0.10 change in log10 cps HIV RNA per swab Interval 0.02 to 0.18
Shedding of HIV-1 From the Cervix Between HIV-positive Women Baseline and Week 2	0.07 change in log10 cps HIV RNA per swab Interval -0.02 to 0.16	0.25 change in log10 cps HIV RNA per swab Interval 0.14 to 0.37
Shedding of HIV-1 From the Cervix Between HIV-positive Women Baseline and Week 3	0.05 change in log10 cps HIV RNA per swab Interval -0.05 to 0.14	0.26 change in log10 cps HIV RNA per swab Interval 0.14 to 0.38

Adverse Events

Cryotherapy

Serious events: 5 serious events

Other events: 2 other events

Deaths: 0 deaths

Loop Electrosurgical Excision Procedure

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cryotherapy n=200 participants at risk 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 n=200 participants at risk 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
Infections and infestations HIV complications	2.5% 5/200 • Number of events 5 • 24 months 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	1.0% 2/200 • Number of events 2 • 24 months 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

Other adverse events

Measure	Cryotherapy n=200 participants at risk 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 n=200 participants at risk 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
Surgical and medical procedures Related to procedure	1.0% 2/200 • Number of events 2 • 24 months 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	0.00% 0/200 • 24 months 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

Additional Information

Dr. Michael H. Chung

University of Washington

Phone: ‭(206) 302-8361‬

Email: mhchung@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place