N/A
N=400
Cryotherapy vs. LEEP to Treat Cervical Intraepithelial Neoplasia (CIN) 2/3 Among HIV-positive Women
Cervical Intraepithelial Neoplasia
Bottom Line
View on ClinicalTrials.gov: NCT01298596 ↗Enrolled (actual)
400
Serious AEs
1.8%
Results posted
Oct 2019
Primary outcome: Primary: Recurrence of Cervical Intraepithelial Neoplasia Among HIV-positive Women — 60; 37 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Loop Electrosurgical Excision Procedure (LEEP) (Procedure); Cryotherapy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Washington
- Primary completion
- Oct 2016
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 | — |
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.
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.
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.