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

Cervical Intraepithelial Neoplasia Clinical Trial

— VICAR2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723956
• Other study ID #: ZA.09.0265
• Status: Completed
• Phase: N/A
• First received: November 6, 2012
• Last updated: September 19, 2014
• Start date: March 2010
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: University of Witwatersrand, South Africa
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• HIV Seropositivity
• Uterine Cervical Dysplasia

Intervention

Procedure:
• 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
• 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.

Locations

Country	Name	City	State
South Africa	Helen Joseph Hospital	Johannesburg	Gauteng

Sponsors (1)

Lead Sponsor	Collaborator
University of Witwatersrand, South Africa

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The ability to use Human Papillomavirus as the measure of treatment success	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.	1 year	No
Secondary	To compare the safety of cryotherapy versus LLETZ in HIV seropositive women	To compare the safety of cryotherapy versus LLETZ in HIV seropositive women by evaluating adverse events as measured by the Division of AIDS toxicity table 2004 (revised August 2010)	1 month, 6 months and 12 months	Yes
Secondary	Describe factors associated with successful treatment of CIN 2/3	To describe HIV disease status (CD4, HIV viral load), demographics, tissue margins and sexual behavior in each treatment arm (LLETZ and cryotherapy) in HIV seropositive women.	1 year	No
Secondary	To determine the cervical disease recurrence rates with cryotherapy and LLETZ.	To determine the cervical disease recurrence rates with cryotherapy and LLETZ at 6 months and 12 months by colposcopy	6 months and 12 months	No