Pneumocystis in Pathogenesis of HIV-associated Emphysema (PACT)
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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: | Observational Model: Cohort Time Perspective: Prospective |
Official Title: | Pneumocystis in Pathogenesis of HIV-associated Emphysema |
oral wash blood sputum BAL
Enrollment: | 250 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | July 2013 |
Primary Completion Date: | September 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. Both HIV positive and negative with and without asthma and/or COPD
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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/or participants in the Pitt Mens study.
Inclusion Criteria:
- Subject is Male / Female 18years of age or older.
- Subject has been previously determined to be HIV-infected or has been participating in the Pitt Men's study or is seen at the UPMC HIV/AIDS program
Exclusion Criteria:
- Subject is experiencing acute onset of shortness of breath, cough, fevers or heart conditions problems such as tachycardia, angina or arrhythmias
- Female subject has told us she is pregnant (this might affect pulmonary function values,we will not require pregnancy testing.)
- Subject has had an MI, CVA, or cardiovascular event within the past 3 months.
- Subject has had eye or abdominal surgery within past 3 months.
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United States, Pennsylvania | |
UPMC Montefiore Hospital, CTRC MUH, Keystone Bldg. | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Alison Morris-Gimbel, MD | University of Pittsburgh |
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No publications provided
Responsible Party: | Alison Morris, MD, University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00869544 History of Changes |
Other Study ID Numbers: | IRB0606151, 5RO1 HL083461 05 |
Study First Received: | March 25, 2009 |
Last Updated: | February 16, 2011 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
HIV smoker emphysema antiretrovirals COPD |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Asthma Emphysema Pulmonary Emphysema Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Pneumonia Pneumonia, Pneumocystis Lung Diseases, Obstructive Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Bronchial Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Pathologic Processes Respiratory Tract Infections Lung Diseases, Fungal Mycoses Pneumocystis Infections |
ClinicalTrials.gov processed this record on March 14, 2013