Validation of Implementation of Cervical Dysplasia Treatment Modalities in HIV-Seropositive Women (VICAR2)
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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.):
- 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.
- 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.
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Gauteng
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Johannesburg, Gauteng, África do Sul, 2092
- Helen Joseph Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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:
- 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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Arm B
LEEP treatment of CIN 2/3 cervical lesion in HIV positive women (standard of Care)
|
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.
Outros nomes:
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Experimental: Arm A
Cryotherapy treatment of CIN 2/3 cervical lesions
|
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
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Compare efficacy of cryotherapy and LEEP
Prazo: 1 year
|
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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The ability to use Human Papillomavirus as the measure of treatment success
Prazo: 1 year
|
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
|
|
To compare the safety of cryotherapy versus LLETZ in HIV seropositive women
Prazo: 1 month, 6 months and 12 months
|
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)
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1 month, 6 months and 12 months
|
|
Describe factors associated with successful treatment of CIN 2/3
Prazo: 1 year
|
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
|
|
To determine the cervical disease recurrence rates with cryotherapy and LLETZ.
Prazo: 6 months and 12 months
|
To determine the cervical disease recurrence rates with cryotherapy and LLETZ at 6 months and 12 months by colposcopy
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6 months and 12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Cynthia S Firnhaber, MD, University of Witwatersrand, South Africa
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Infecções por vírus de RNA
- Doenças Virais
- Infecções
- Infecções transmitidas pelo sangue
- Doenças Transmissíveis
- Doenças Sexualmente Transmissíveis, Virais
- Doenças Sexualmente Transmissíveis
- Infecções por Lentivírus
- Infecções por Retroviridae
- Síndromes de Deficiência Imunológica
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Neoplasias
- Carcinoma
- Neoplasias Glandulares e Epiteliais
- Doenças do colo do útero
- Doenças uterinas
- Condições pré-cancerosas
- Infecções por HIV
- Carcinoma in situ
- Neoplasia intra-epitelial cervical
- Soropositividade para HIV
- Displasia Cervical Uterina
Outros números de identificação do estudo
- ZA.09.0265
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