Validation of Implementation of Cervical Dysplasia Treatment Modalities in HIV-Seropositive Women

NCT01723956 | Completed DMC

• 1 other identifier: ZA.09.0265
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cervical Intraepithelial Neoplasia

Keywords

Cervical Dysplasia; Cin 2; Cin 3; HIV positive women; South Africa

Outcome Measures

Primary Outcomes (1)

• Compare efficacy of cryotherapy and LEEP

  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 HPV.

  1 year

Secondary Outcomes (4)

• The ability to use Human Papillomavirus as the measure of treatment success

  1 year

• To compare the safety of cryotherapy versus LLETZ in HIV seropositive women

  1 month, 6 months and 12 months

• Describe factors associated with successful treatment of CIN 2/3

  1 year

• To determine the cervical disease recurrence rates with cryotherapy and LLETZ.

  6 months and 12 months

Study Arms (2)

Arm B

ACTIVE COMPARATOR

LEEP treatment of CIN 2/3 cervical lesion in HIV positive women (standard of Care)

Procedure: LEEP

Arm A

EXPERIMENTAL

Cryotherapy treatment of CIN 2/3 cervical lesions

Procedure: Cryotherapy

Interventions

Cryotherapy PROCEDURE

This is involves freezing the lesions with a cryo gun using Nitrous Oxide for 3 minutes-- wait 5 minutes and then refreezing for 3 more minutes. This procedure uses the Wallach cryogun

Also known as: This is a study using Freezing with a cryogun

Arm A

LEEP PROCEDURE

The cervix is anaesthetized with lidocaine and then a electric loop is applied to the cervical lesion which is cut with one pass. The LEEP machine used is the automatic Finesse Machine.

Also known as: Loop Electric Excision Procedure

Arm B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Lesion is greater than ≥75% cervix
• Lesion entering into the cervical canal and the complete lesion cannot be visualized
• Presence of abnormal vasculature
• Lesion bigger that the cryotherapy probe

Sponsors & Collaborators

• University of Witwatersrand, South Africa: lead

Study Sites (1)

Helen Joseph Hospital

Johannesburg, Gauteng, 2092, South Africa

Location

Related Publications (1)

• Smith 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 DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Cynthia S Firnhaber, MD

  University of Witwatersrand, South Africa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: November 8, 2012
• Study Start: March 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 22, 2014

Record last verified: 2014-08

Locations

ZA (1)