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

NCT ID: NCT01723956

Last Updated: 2014-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2014-08-31

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

Detailed Description

Cervical cancer is the most common cancer in HIV positive women. This is due to immunosuppression and lack of organized and effective screening and treatment programs in Africa. Other screening and treatment modalities need to be evaluated in resource limited countries as there is not capacity in most of these countries to implement a cytology/histology based program. The treatment modality of cryotherapy is easy to train and perform and can be done by a nurse. LEEP requires significant training usually doctors and skills in administering local anaesthetic. This study compares the two modalities of cryotherapy vs LEEP in a randomized controlled study in HIV positive women in South Africa.

A. PRIMARY AIMS (S.A.):

1. 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.

2. To determine the utility of subsequent HPV DNA testing as a marker of effective treatment following the treatment of CIN 2/3 among HIV-seropositive women.

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

SECONDARY AIMS:

1. To describe HIV disease status (CD4, HIV viral load), demographics, and sexual behavior in each treatment arm (LLETZ and cryotherapy) in HIV seropositive women.

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

4. To evaluate the relationship between HIV status, demographics, HPV, and sexual behavior with the clearance of cervical disease at the ectocervical and endocervical margins in HIV seropositive women.

Conditions

Cervical Intraepithelial Neoplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm B

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

Group Type: ACTIVE_COMPARATOR

LEEP

Intervention Type: 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.

Arm A

Cryotherapy treatment of CIN 2/3 cervical lesions

Group Type: EXPERIMENTAL

Cryotherapy

Intervention Type: 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

Interventions

Cryotherapy

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

Intervention Type: PROCEDURE

LEEP

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.

Intervention Type: PROCEDURE

Other Intervention Names

This is a study using Freezing with a cryogun; Loop Electric Excision Procedure

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Witwatersrand, South Africa

OTHER

Sponsor Role: lead

Responsible Party

Cynthia S Firnhaber

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cynthia S Firnhaber, MD

Role: PRINCIPAL_INVESTIGATOR

University of Witwatersrand, South Africa

Locations

Helen Joseph Hospital

Johannesburg, Gauteng, South Africa

Countries

South Africa

References

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.

Reference Type: DERIVED

PMID: 28366730 (View on PubMed)

Other Identifiers

ZA.09.0265

Identifier Type: -

Identifier Source: org_study_id