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| Sponsor: | University of Pittsburgh |
|---|---|
| Collaborators: |
University of California, Los Angeles University of California, San Francisco |
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00870857 |
Purpose
Despite the availability of highly active antiretroviral therapy (HAART), lung diseases remain a leading cause of morbidity and mortality in those with HIV infection. There have been no large-scale studies detailing pulmonary complications in the HAART era. Substantial gaps exist in our knowledge of the spectrum and pathogenesis of pulmonary disorders in this population, particularly in women and minorities whose numbers with HIV or AIDS have increased. The Multicenter AIDS Cohort Study (MACS) and the Women's Interagency Health Study (WIHS) are prospective, multi-center cohorts that follow approximately 5000 HIV+ subjects and HIV- controls. Although pulmonary disease has not been an area of focus, these established cohorts provide a unique opportunity to systematically study pulmonary complications of HIV infection.
Emphysema is of particular interest in the current HIV era because it is likely to increase as this population lives longer with chronic HIV. HIV-infected persons have an increased incidence of emphysema compared to those without HIV infection, and it has been hypothesized that this accelerated disease progression is the result of one or more latent infectious agents that amplify the pulmonary inflammation. Accelerated emphysema was described in HIV infection in a predominantly male population before HAART. The current prevalence and characteristics of HIV-associated emphysema, and the potential impact of gender, have not been rigorously defined.
| Condition |
|---|
|
HIV Infections Emphysema Chronic Obstructive Pulmonary Disease Pneumocystis |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Prevalence and Pathogenesis of Lung Disease in a Large HIV Cohort-Coordinating Center |
| Estimated Enrollment: | 600 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
HIV+ and HIV- subjects from the MACS and WIHS studies
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Subjects will be recruited from the University of Pittsburgh and the University of California Los Angles MACS sites. The University of California San Francisco will serve as the recruiting center for the WIHS cohort.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Cathy J Kessinger, RN | 412*802-8524 | Kessingercj@upmc.edu |
| Contact: Lorrie Lucht, BS | 412-692-2263 | Luchtla@upmc.edu |
| United States, California | |
| UCLA | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Eric C Kleerup, MD 310-794-6593 EKleerup@mednet.ucla.edu | |
| Principal Investigator: Eric Kleerup, MD | |
| UCSF | Recruiting |
| San Francisco, California, United States, 94118 | |
| Contact: Claudia Ponath 415-502-6290 Claudia.ponath@ucsf.edu | |
| Principal Investigator: Laurence Huang, MD | |
| Principal Investigator: | Alison Morris-Gimbel, MD | University of Pittsburgh |
More Information
| Responsible Party: | University of Pittsburgh ( Alison Morris, MD ) |
| Study ID Numbers: | PRO08050145, 5R01 HL090339 02 |
| Study First Received: | March 25, 2009 |
| Last Updated: | March 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00870857 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Lungs antiretrovirals HIV COPD |
|
Sexually Transmitted Diseases, Viral Slow Virus Diseases Infection Pulmonary Emphysema Pneumonia, Pneumocystis Mycoses Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Diseases Respiratory Tract Infections Retroviridae Infections Lung Diseases, Fungal Emphysema |
RNA Virus Infections Immune System Diseases Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Virus Diseases Pneumocystis Infections HIV Infections Lung Diseases Sexually Transmitted Diseases Lentivirus Infections Pneumonia Pulmonary Disease, Chronic Obstructive |