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Validation of Implementation of Cervical Dysplasia Treatment Modalities in HIV-Seropositive Women (VICAR 2)

This study is currently recruiting participants.
Verified November 2012 by University of Witwatersrand, South Africa
Sponsor:
Information provided by (Responsible Party):
Cynthia S Firnhaber, University of Witwatersrand, South Africa
ClinicalTrials.gov Identifier:
NCT01723956
First received: November 6, 2012
Last updated: November 9, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention
Cervical Dysplasia in HIV Positive Women
 Procedure: Cryotherapy
Procedure: LEEP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Validation of Implementation of Cervical Dysplasia Treatment Modalities in HIV-Seropositive Women

Resource links provided by NLM:

MedlinePlus related topics: Cancer HIV/AIDS
U.S. FDA Resources

Further study details as provided by University of Witwatersrand, South Africa:

Primary Outcome Measures:
  • Compare efficacy of cryotherapy and LEEP [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The ability to use Human Papillomavirus as the measure of treatment success [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • To compare the safety of cryotherapy versus LLETZ in HIV seropositive women [ Time Frame: 1 month, 6 months and 12 months ] [ Designated as safety issue: Yes ]
    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)

  • Describe factors associated with successful treatment of CIN 2/3 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • To determine the cervical disease recurrence rates with cryotherapy and LLETZ. [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    To determine the cervical disease recurrence rates with cryotherapy and LLETZ at 6 months and 12 months by colposcopy


Estimated Enrollment: 166
Study Start Date: March 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm B
LEEP treatment of CIN 2/3 cervical lesion in HIV positive women (standard of Care)
 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.
Other Name: Loop Electric Excision Procedure
Experimental: Arm A
Cryotherapy treatment of CIN 2/3 cervical lesions
 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
Other Names:
  • There are NO drugs or new devises. This is a study comparing two
  • different types of outpatient procedure Freezing with a cryogun or using
  • the LEEP procedure.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

      -

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01723956

Contacts
Contact: Cynthia S Firnhaber, MD 27-11-276-8800 cfirnhaber@witshealth.co.za
Contact: Nomtha Mayisela, MBBCh 27-11-276-8850 nomtha.mayisela@righttocare.org

Locations
South Africa
Helen Joseph Hospital Recruiting
Johannesburg, Gauteng, South Africa, 2092
Contact: Cynthia Firnhaber         cfirnhaber@witshealth.co.za    
Principal Investigator: Cynthia S Firnhaber, MD            
Sponsors and Collaborators
University of Witwatersrand, South Africa
  More Information

No publications provided

Responsible Party: Cynthia S Firnhaber, Associate Professor of Medicine, University of Witwatersrand, South Africa
ClinicalTrials.gov Identifier: NCT01723956     History of Changes
Other Study ID Numbers: ZA.09.0265
Study First Received: November 6, 2012
Last Updated: November 9, 2012
Health Authority: South Africa USAID: Public Health Evaluation Committee of Office of Global Aids Coordinator

Keywords provided by University of Witwatersrand, South Africa:
Cervical Dysplasia
Cin 2
Cin 3
HIV positive women
South Africa

Additional relevant MeSH terms:
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
HIV Seropositivity
Hyperplasia
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013