Pneumocystis in Pathogenesis of HIV-associated Emphysema (PACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00869544
Recruitment Status : Completed
First Posted : March 26, 2009
Last Update Posted : September 5, 2014
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Cathy Kessinger, University of Pittsburgh

Brief Summary:

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 or disease
HIV Infections Pneumocystis Pneumonia Emphysema Chronic Obstructive Pulmonary Disease Asthma

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pneumocystis in Pathogenesis of HIV-associated Emphysema
Study Start Date : August 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema HIV/AIDS

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

Biospecimen Retention:   Samples With DNA
oral wash blood sputum BAL

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00869544

United States, Pennsylvania
UPMC Montefiore Hospital, CTRC MUH, Keystone Bldg.
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
Principal Investigator: Alison Morris-Gimbel, MD University of Pittsburgh

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cathy Kessinger, clinical research coordinator, University of Pittsburgh Identifier: NCT00869544     History of Changes
Other Study ID Numbers: IRB0606151
5R01HL083461-05 ( U.S. NIH Grant/Contract )
First Posted: March 26, 2009    Key Record Dates
Last Update Posted: September 5, 2014
Last Verified: September 2014

Keywords provided by Cathy Kessinger, University of Pittsburgh:

Additional relevant MeSH terms:
Lung Diseases
HIV Infections
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Emphysema
Pneumonia, Pneumocystis
Respiratory Tract Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Respiratory Tract Infections
Pathologic Processes
Lung Diseases, Fungal
Pneumocystis Infections