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

Cervical Intraepithelial Neoplasia Clinical Trial

— PHE-LEEP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298596
• Other study ID #: 35995-J
• Secondary ID: KE.09.0238
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: January 2017

Study information

• Verified date: October 2019
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Neoplasms

Intervention

Procedure:
• Loop Electrosurgical Excision Procedure (LEEP)
LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix
• Cryotherapy
Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix

Locations

Country	Name	City	State
Kenya	Coptic Hospital	Nairobi

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	International Agency for Research on Cancer, University of Nairobi

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of Cervical Intraepithelial Neoplasia Among HIV-positive Women	Rate of recurrence of cervical intraepithelial neoplasia among HIV-positive women receiving cryotherapy versus LEEP over 2 years of follow-up	2 years
Secondary	Shedding of HIV-1 From the Cervix Between HIV-positive Women	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	3 weeks