N/A Completed N=400 Randomized Treatment

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

Cervical Intraepithelial Neoplasia

Source: ClinicalTrials.gov NCT01298596 ↗

Enrolled (actual)

400

Serious AEs

1.8%

Results posted

Oct 2019

Primary outcomePrimary: Recurrence of Cervical Intraepithelial Neoplasia Among HIV-positive Women — 60; 37 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Recurrence of Cervical Intraepithelial Neoplasia Among HIV-positive Women	60; 37	—
SECONDARY Shedding of HIV-1 From the Cervix Between HIV-positive Women	-0.02; 0.10; 0.07; 0.25; 0.05; 0.26	—

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01298596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.