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

NCT00870857 | Completed DMC

• 2 other identifiers: PRO080501455R01HL090339-02
• Study Type: observational
• Target: 407
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

HIV Infections; Emphysema; Chronic Obstructive Pulmonary Disease; Pneumocystis

Keywords

Lungs; antiretrovirals; HIV; COPD

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  5 years

Study Arms (1)

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 Washington (UW) MACS sites. The University of California San Francisco (UCSF) will serve as the recruiting center for the WIHS cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of California, San Francisco: collaborator
• University of Washington: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

UCLA

Los Angeles, California, 90095, United States

Location

UCSF

San Francisco, California, 94118, United States

Location

Related Publications (1)

• Cui L, Lucht L, Tipton L, Rogers MB, Fitch A, Kessinger C, Camp D, Kingsley L, Leo N, Greenblatt RM, Fong S, Stone S, Dermand JC, Kleerup EC, Huang L, Morris A, Ghedin E. Topographic diversity of the respiratory tract mycobiome and alteration in HIV and lung disease. Am J Respir Crit Care Med. 2015 Apr 15;191(8):932-42. doi: 10.1164/rccm.201409-1583OC.

  PMID: 25603113 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood oral wash sputum BAL

MeSH Terms

Conditions

HIV Infections; Emphysema; Pulmonary Disease, Chronic Obstructive; Pneumonia, Pneumocystis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia

Study Officials

• Alison Morris-Gimbel, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: March 27, 2009
• Study Start: January 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: August 1, 2016
• Last Updated: August 26, 2025

Record last verified: 2016-10

Locations

US (2)