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Pneumocystis in Pathogenesis of HIV-associated Emphysema (PACT)

This study has been completed.
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Cathy Kessinger, University of Pittsburgh Identifier:
First received: March 25, 2009
Last updated: September 4, 2014
Last verified: September 2014

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

HIV Infections
Pneumocystis Pneumonia
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pneumocystis in Pathogenesis of HIV-associated Emphysema

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples With DNA
oral wash blood sputum BAL

Enrollment: 250
Study Start Date: August 2007
Study Completion Date: July 2013
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
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

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Cathy Kessinger, clinical research coordinator, University of Pittsburgh Identifier: NCT00869544     History of Changes
Other Study ID Numbers: IRB0606151  5R01HL083461-05 
Study First Received: March 25, 2009
Last Updated: September 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Additional relevant MeSH terms:
HIV Infections
Lung Diseases
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 processed this record on October 21, 2016