Pneumocystis in Pathogenesis of HIV-associated Emphysema (PACT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cathy Kessinger, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00869544
First received: March 25, 2009
Last updated: June 17, 2013
Last verified: February 2011
  Purpose

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
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

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
Estimated Study Completion Date: July 2013
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
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.

Criteria

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 ClinicalTrials.gov identifier: NCT00869544

Locations
United States, Pennsylvania
UPMC Montefiore Hospital, CTRC MUH, Keystone Bldg.
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Alison Morris-Gimbel, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Cathy Kessinger, clinical research coordinator, 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: June 17, 2013
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
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 August 01, 2014