Brief Title
Validation of Implementation of Cervical Dysplasia Treatment Modalities in HIV-Seropositive Women
Official Title
Validation of Implementation of Cervical Dysplasia Treatment Modalities in HIV-Seropositive Women
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.
Study Type
Interventional
Primary Outcome
Compare efficacy of cryotherapy and LEEP
Secondary Outcome
The ability to use Human Papillomavirus as the measure of treatment success
Condition
Cervical Intraepithelial Neoplasia
Intervention
Cryotherapy
Study Arms / Comparison Groups
Arm B
Description: LEEP treatment of CIN 2/3 cervical lesion in HIV positive women (standard of Care)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
166
Start Date
March 2010
Completion Date
August 2014
Primary Completion Date
August 2014
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
Gender
Female
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Cynthia S Firnhaber, MD, ,
Location Countries
South Africa
Location Countries
South Africa
Administrative Informations
NCT ID
NCT01723956
Organization ID
ZA.09.0265
Responsible Party
Principal Investigator
Study Sponsor
University of Witwatersrand, South Africa
Study Sponsor
Cynthia S Firnhaber, MD, Principal Investigator, University of Witwatersrand, South Africa
Verification Date
August 2014