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Sponsored by: |
University of Pittsburgh |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00869544 |
A. Statement of Hypotheses:
HIV-infected patients have an increased incidence of emphysema compared to non-HIV-infected smokers, and it has been hypothesized that this accelerated disease progression is the result of one or more latent infections that amplifies the pulmonary inflammatory response to cigarette smoke. Pneumocystis is one infectious agent that likely plays a key role in the development of HIV-associated emphysema. Colonization with Pneumocystis has been demonstrated in HIV-infected subjects, and HIV-infected smokers are particularly susceptible to Pc colonization regardless of CD4 cell count or use of prophylaxis. Pneumocystis colonization is also increased in non-HIV-infected patients with chronic obstructive pulmonary disease (COPD) and is directly related to the severity of the disease. The presence of Pneumocystis in the lungs, even at low levels as seen in colonization, produces inflammatory changes similar to those seen in COPD, with increases in the numbers of neutrophils and cytotoxic CD8+ lymphocytes. We propose that Pneumocystis accelerates emphysema in HIV-infected smokers by stimulating inflammation and tissue destruction. We will examine the role of co-infection with Pneumocystis in the pathogenesis of HIV-associated emphysema and the mechanism by which it causes emphysema progression. These studies will lead to information that will provide a rational basis for prevention and therapy of HIV-associated emphysema and provide a model for emphysema in the general population
Condition |
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HIV Infections Pneumocystis Pneumonia Emphysema Chronic Obstructive Pulmonary Disease Asthma |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Pneumocystis in Pathogenesis of HIV-Associated Emphysema |
Estimated Enrollment: | 300 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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HIV
Those positive for HIV and those negative but at high risk for HIV. Both positive and negative for HIV who smoke and those who do not smoke.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
patients who have been determined to attend the UPMC HIV/AIDS program and participants in the Pitt Mens study.
Inclusion Criteria:
Exclusion Criteria:
Contact: Cathy J Kessinger, RN | 412-802-8524 | kessingercj@upmc.edu |
Contact: Lorrie Lucht, BS | 412-692-2263 | luchtla@upmc.edu |
United States, Pennsylvania | |
UPMC Montefiore Hospital, CTRC MUH, Keystone Bldg. | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Cathy J Kessinger, RN 412-802-8520 kessingercj@upmc.edu | |
Contact: Lorrie Lucht, BS 412-692-2263 Luchtla@upmc.edu | |
Principal Investigator: Alison Morris, MD |
Principal Investigator: | Alison Morris-Gimbel, MD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh ( Alison Morris, MD ) |
Study ID Numbers: | IRB0606151, 5RO1 HL083461 05 |
Study First Received: | March 25, 2009 |
Last Updated: | March 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00869544 History of Changes |
Health Authority: | United States: Institutional Review Board |
HIV smoker emphysema antiretrovirals COPD |
Emphysema Sexually Transmitted Diseases, Viral Pneumocystosis Acquired Immunodeficiency Syndrome Asthma Immunologic Deficiency Syndromes Pulmonary Emphysema Virus Diseases Mycoses Pneumonia, Pneumocystis Lung Diseases, Obstructive |
Pneumocystis Infections Respiratory Tract Infections Respiratory Tract Diseases HIV Infections Lung Diseases Sexually Transmitted Diseases Retroviridae Infections Pneumonia Lung Diseases, Fungal Pulmonary Disease, Chronic Obstructive |
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 |