Clinical trial · Interventional
Validation of Implementation of Cervical Dysplasia Treatment Modalities in HIV-Seropositive Women
NCT01723956CI-TRIAL-00015672VICAR2completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To compare the efficacy of cryotherapy and large loop excision of the transformation zone (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and Human Papillomavirus. Hypothesis: LEEP will be more effective than cryotherapy in removing CIN 2/3 lesions in HIV positive women in South Africa
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryotherapy | Procedure | — | UNRESOLVED |
| LEEP | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- LEEP treatment of CIN 2/3 cervical lesion in HIV positive women (standard of Care)
- interventionNames
- Procedure: LEEP
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Cryotherapy treatment of CIN 2/3 cervical lesions
- interventionNames
- Procedure: Cryotherapy
Primary outcomes (1)
- measure
- Compare efficacy of cryotherapy and LEEP
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Women 18-65 years of age * Not menstruating (if menstruating, the patient can be screened at another date) * Able to sign consent * Able to follow the study protocol * HIV positive (by two different criteria; either 2 different rapid HPV tests of different manufacturers, a HIV viral load ≥5,000,ELISA, Western blot documented in VICAR 1) * Participant with histology-proven CIN 2 or 3 disease Exclusion Criteria: * Pregnant * Clinically active sexually transmitted disease determined by clinical history and/or physical exam (may participate after adequate treatment by syndromic treatment management) * Known and previous treatment for high grade squamouse intraepithelial lesion by any method (cryotherapy, LLETZ or cone biopsy) * Previous hysterectomy with removal of the cervix * Significant medical illness/mental illness that the investigator feels would prevent the participant from complying with the protocol or place the participant at medical risk * Cervical dysplastic lesions that are not appropriate for cryotherapy, defined as the following: 1. Lesion is greater than ≥75% cervix 2. Lesion entering into the cervical canal and the complete lesion cannot be visualized 3. Presence of abnormal vasculature 4. Lesion bigger that the cryotherapy probe
References
Publications (1)
- DERIVEDSmith JS, Sanusi B, Swarts A, Faesen M, Levin S, Goeieman B, Ramotshela S, Rakhombe N, Williamson AL, Michelow P, Omar T, Hudgens MG, Firnhaber C. A randomized clinical trial comparing cervical dysplasia treatment with cryotherapy vs loop electrosurgical excision procedure in HIV-seropositive women from Johannesburg, South Africa. Am J Obstet Gynecol. 2017 Aug;217(2):183.e1-183.e11. doi: 10.1016/j.ajog.2017.03.022. Epub 2017 Mar 31. PMID 28366730