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Prevalence and Pathogenesis of Lung Disease in a Large HIV Cohort-Coordinating Center (MACS)
This study is currently recruiting participants.
Verified by University of Pittsburgh, March 2009
First Received: March 25, 2009   Last Updated: March 26, 2009   History of Changes
Sponsor: University of Pittsburgh
Collaborators: University of California, Los Angeles
University of California, San Francisco
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00870857
  Purpose

Despite the availability of highly active antiretroviral therapy (HAART), lung diseases remain a leading cause of morbidity and mortality in those with HIV infection. There have been no large-scale studies detailing pulmonary complications in the HAART era. Substantial gaps exist in our knowledge of the spectrum and pathogenesis of pulmonary disorders in this population, particularly in women and minorities whose numbers with HIV or AIDS have increased. The Multicenter AIDS Cohort Study (MACS) and the Women's Interagency Health Study (WIHS) are prospective, multi-center cohorts that follow approximately 5000 HIV+ subjects and HIV- controls. Although pulmonary disease has not been an area of focus, these established cohorts provide a unique opportunity to systematically study pulmonary complications of HIV infection.

Emphysema is of particular interest in the current HIV era because it is likely to increase as this population lives longer with chronic HIV. HIV-infected persons have an increased incidence of emphysema compared to those without HIV infection, and it has been hypothesized that this accelerated disease progression is the result of one or more latent infectious agents that amplify the pulmonary inflammation. Accelerated emphysema was described in HIV infection in a predominantly male population before HAART. The current prevalence and characteristics of HIV-associated emphysema, and the potential impact of gender, have not been rigorously defined.


Condition
HIV Infections
Emphysema
Chronic Obstructive Pulmonary Disease
Pneumocystis

Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Prevalence and Pathogenesis of Lung Disease in a Large HIV Cohort-Coordinating Center

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Estimated Enrollment: 600
Study Start Date: January 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
HIV+ and HIV- subjects from the MACS and WIHS studies

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects will be recruited from the University of Pittsburgh and the University of California Los Angles MACS sites. The University of California San Francisco will serve as the recruiting center for the WIHS cohort.

Criteria

Inclusion Criteria:

  • Subject is Male / Female 18years of age or older.
  • Subject has been previously determined to be HIV-infected or is participating in the The Multicenter AIDS Cohort Study (MACS) or the Women's Interagency Health Study (WIHS)

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.
  • Active TB by documentation or self reported will be exclusion criteria to the study.
  • Subjects will be excluded from the study if they are unable to sign consent, weigh > 300 pounds due to technical difficulties with the CT/EBCT scanner, or have been exposed to approximately 10 rads in the previous 12 months (i.e., 2 diagnostic CT scans or 4 cardiac caths or other fluoroscopic exams).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00870857

Contacts
Contact: Cathy J Kessinger, RN 412*802-8524 Kessingercj@upmc.edu
Contact: Lorrie Lucht, BS 412-692-2263 Luchtla@upmc.edu

Locations
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Eric C Kleerup, MD     310-794-6593     EKleerup@mednet.ucla.edu    
Principal Investigator: Eric Kleerup, MD            
UCSF Recruiting
San Francisco, California, United States, 94118
Contact: Claudia Ponath     415-502-6290     Claudia.ponath@ucsf.edu    
Principal Investigator: Laurence Huang, MD            
Sponsors and Collaborators
University of Pittsburgh
University of California, Los Angeles
University of California, San Francisco
Investigators
Principal Investigator: Alison Morris-Gimbel, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh ( Alison Morris, MD )
Study ID Numbers: PRO08050145, 5R01 HL090339 02
Study First Received: March 25, 2009
Last Updated: March 26, 2009
ClinicalTrials.gov Identifier: NCT00870857     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Lungs
antiretrovirals
HIV
COPD

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010