Prevalence and Pathogenesis of Lung Disease in a Large HIV Cohort-coordinating Center (MACS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of California, Los Angeles
University of California, San Francisco
Information provided by (Responsible Party):
Cathy Kessinger, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00870857
First received: March 25, 2009
Last updated: September 4, 2014
Last verified: September 2014
  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: Observational Model: Cohort
Time Perspective: 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:

Primary Outcome Measures:
  • The overall objective of the Pitt coordinating center is to build a collaborative collection of data and specimens that will facilitate the study and understanding of HIV and pulmonary disease [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    This prospective, multicenter cohort study will survey HIV-infected and non-infected individuals and test for airway obstruction and emphysema and determine associated risk factors. Subjects may be invited back for repeat testing at 18 and 36 months based on the initial test results and measures. Subjects at the multicenter sites may participate in this study for approximately 36 months. Each individual site (University of Pittsburgh, UCLA, UCSF) will be a descriptive longitudinal study to examine the prevalence and progression of emphysema in HIV+ and HIV-subjects.


Biospecimen Retention:   Samples With DNA

blood oral wash sputum BAL


Estimated Enrollment: 600
Study Start Date: January 2009
Estimated Study Completion Date: April 2015
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Subjects will be 300 HIV+ subjects and 300 HIV- controls selected by random sampling stratified by age and smoking history. Subjects will be recruited from the University of Pittsburgh and the University of California Los Angles (UCLA) MACS sites. The University of California San Francisco (UCSF) will serve as the recruiting center for the WIHS cohort

Detailed Description:

HIV-infected patients have an increased incidence of emphysema compared to non-HIV-infected patients, 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. We will examine the prevalence and progression of emphysema in subjects with and without HIV and determine risk factors for emphysema in this population.

Subjects will be 300 HIV+ subjects and 300 HIV- controls selected by random sampling stratified by age and smoking history. Subjects will be recruited from the University of Pittsburgh and the University of California Los Angles (UCLA) MACS sites. The University of California San Francisco (UCSF) will serve as the recruiting center for the WIHS cohort. Because we are interested in an unbiased estimate of the extent of this disease in HIV infection, we will not select subjects based on lung function or current diagnosis of COPD. The HIV- subjects will be matched to the HIV+ subjects in terms of age and smoking history to the extent possible. Those with symptoms of acute respiratory disease such as fevers, acute change in cough or shortness of breath, or weight loss will be excluded. There will be no exclusions based on HAART use or opportunistic infection (OI) prophylaxis and no exclusions based on previous lung disease as we are trying to obtain a comprehensive evaluation of emphysema in this population as well as identify associated risk factors.

All subjects will undergo spirometry, diffusing capacity and quantitative CT scanning. These measurements will allow us to determine differences in the prevalence of emphysema in HIV+ and HIV- and determine risk factors associated with emphysema. For longitudinal studies testing the hypothesis that emphysema is accelerated in HIV infection, we will select HIV+ and HIV- subjects with documented emphysema in each group as defined by diffusing capacity<80% predicted, post-bronchodilator FEV1/FVC<70% without significant reversibility, or at least 10% of lung with a density less than -910 Hounsfield units (HU). These subjects will have CT scans and PFTs at baseline and at 18 months and 36 months after baseline. At each visit, clinical data and biological samples will be collected.

  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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00870857

Locations
United States, California
UCLA
Los Angeles, California, United States, 90095
UCSF
San Francisco, California, United States, 94118
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: Cathy Kessinger, clinical research coordinator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00870857     History of Changes
Other Study ID Numbers: PRO08050145, 5R01 HL090339 02
Study First Received: March 25, 2009
Last Updated: September 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Lungs
antiretrovirals
HIV
COPD

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pneumonia, Pneumocystis
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
Respiratory Tract Diseases
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections
Pneumonia
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 01, 2014