- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01326572
Lung HIV Disease in a Large Cohort-Pitt (MACS)
Prevalence and Pathogenesis of Lung Disease in a Large HIV Cohort-Pitt
Visão geral do estudo
Status
Condições
Descrição detalhada
Specific Aim 1: To test the hypothesis that emphysema is more prevalent and progresses more quickly in HIV+ subjects compared to HIV- controls: The investigators will characterize the prevalence, nature, and progression of HIV-associated emphysema. Emphysema will be determined in HIV+ and HIV- subjects by spirometry, diffusing capacity, and quantitative computed tomography and/or EBCT. These studies will be repeated at 18 and 36 months after baseline to assess differences in progression between HIV+ and HIV- subjects. Multifactorial regression analyses will determine the contribution of various risk factors to presence and progression of emphysema.
The investigators will perform pulmonary function testing at baseline and compare degree of obstruction according to HIV status while adjusting for other clinical variables that influence lung function. Assessment of degree of emphysema and its distribution can be accomplished using quantitative CT morphometry density analysis. This technique measures lung density by pixel analysis expressed in Hounsfield units (HU) or its inverse (ml of gas/gram of tissue) which increases proportionately with the magnitude of emphysema. These measurements have been histologically-verified and give quantitative, reproducible measurements of percentage and distribution of lung considered normal, mildly emphysematous, and severely emphysematous. The investigators will compare emphysema in the HIV+ and HIV- subjects and compare progression over time.
Specific Aim 2: To establish a bank of saliva, sputum, serum, plasma, DNA, RNA, proteins and cells from the biological samples of these subjects with a purpose of performing future proteomic and genomic analyses of gene expression, genetic associations, disease pathogenesis and markers of disease progression in subjects with HIV infection and lung diseases:
2a) To test the role of low level infections with physiologic obstruction in HIV-infected patients. The investigators will examine the role of co-infection with Pneumocystis and other microbes in the pathogenesis of HIV-associated emphysema and the mechanism by which they cause emphysema progression by examining induced sputum specimens at baseline, 18 months, and 36 months.
Specific Aim 3. To test the hypothesis that persistent, sub-clinical infection in HIV+ subjects augments the pulmonary inflammatory response and leads to emphysema.
3a. To test the hypothesis that pulmonary colonization is increased in subjects with HIV-associated emphysema. The investigators will perform serial bronchoscopic alveolar lavage (BAL) in four groups of HIV+ and HIV - subjects: smokers with emphysema, smokers without emphysema, non-smokers with emphysema, and non-smokers without emphysema at the four sub-study sites. The investigators will use culture and molecular techniques to test for pathogens associated with emphysema and/or HIV and compare results between groups at baseline and over time to test our hypothesis that HIV+ subjects with emphysema harbor sub-clinical infection and that these infections accelerate lung damage and inflammation. The investigators will also determine pulmonary HIV levels and their relationship to emphysema and colonization.
3b. To test the hypothesis that local inflammatory responses and proteases are upregulated in HIV+ subjects with emphysema. BAL cellular infiltration will be characterized by flow cytometry to develop a quantitative and qualitative evaluation of cellular inflammatory responses in the four patient groups in Aim 3a. Lymphocyte populations will be analyzed for activation markers and intra-cellular cytokine production. The investigators will measure cytokine expression and protease levels in BAL supernatant as well as macrophage protease production. The investigators will compare results between groups and correlate with infections and HIV BAL viral levels.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh
-
Pittsburgh, Pennsylvania, Estados Unidos, 15213
- UPMC Montefiore Hospital, CTRC MUH, Keystone Bldg.
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Age 18 years old or older
- By participant's report, s/he is:
- HIV positive OR
- HIV negative and at high risk
- Recruited via:
- Pitt Men's Study/MAC
- Women's Interagency Health Study
- Attendee of UPMC HIV/AIDS Program
Exclusion Criteria:
- Acute onset of shortness of breath, cough, fever or heart condition such as tachycardia, angina or arrhythmias
- Pregnancy
- MI, CVA or cardiovascular event within last 3 months
- Eye or abdominal surgery with last 3 months
- Active TB by documentation or self-report
- Weight > 500 lbs.
- Exposure to > 10 rads in the previous 12 months (i.e., 2 CT or 4 cardiac cath…or other fluoroscopic exams For bronchoscopy subjects only
- Subjects with an upper or lower respiratory tract infection
- Individuals with a Primary diagnosis of vocal cord dysfunction, or those with significant or uncontrolled systemic diseases will be excluded
- 75 years of age or older
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
---|
female, male, HIV, lung disease
All participants in the University of Pittsburgh Multicenter AIDS Cohort Study are eligible for this protocol.
All participants in the UCSF Women's HIV study are eligible and all Men from the UCLA men's HIV study are eligible
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
The investigators will compare emphysema in the HIV+ and HIV- subjects and compare progression over time.
Prazo: 36 months
|
The investigators will perform pulmonary function testing at baseline and compare degree of obstruction according to HIV status while adjusting for other clinical variables that influence lung function.
Assessment of degree of emphysema and its distribution can be accomplished using quantitative CT morphometry density analysis.
PFT, sputum, CT will be done at baseline, 18mo and 36 mo.
|
36 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Alison Morris-Gimbel, MD, MS, University of Pittsburgh
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
Outros números de identificação do estudo
- LUNG007
- 5R01HL090339 (Concessão/Contrato do NIH dos EUA)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .