NCT01326572

Brief Summary

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. The investigators will examine the prevalence and progression of emphysema in subjects with and without HIV and determine risk factors for emphysema in this population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 31, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

August 26, 2025

Status Verified

May 1, 2016

Enrollment Period

7 years

First QC Date

February 21, 2011

Last Update Submit

August 19, 2025

Conditions

Pulmonary DiseaseHIVEmphysema

Keywords

HIVPulmonary diseaseemphysemaCOPD

Outcome Measures

Primary Outcomes (1)

  • The investigators will compare emphysema in the HIV+ and HIV- subjects and compare progression over time.

    The investigators will perform pulmonary function testing at baseline and compare degree of obstruction according to HIV status while adjusting for other clinical variables that influence lung function. Assessment of degree of emphysema and its distribution can be accomplished using quantitative CT morphometry density analysis. PFT, sputum, CT will be done at baseline, 18mo and 36 mo.

    36 months

Study Arms (1)

female, male, HIV, lung disease

All participants in the University of Pittsburgh Multicenter AIDS Cohort Study are eligible for this protocol. All participants in the UCSF Women's HIV study are eligible and all Men from the UCLA men's HIV study are eligible

Eligibility Criteria

Age18 Years - 72 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

primary clinic for Pittsburghs Mens Aids Clinic Study(MACS)

You may qualify if:

  • Age 18 years old or older
  • By participant's report, s/he is:
  • HIV positive OR
  • HIV negative and at high risk
  • Recruited via:
  • Pitt Men's Study/MAC
  • Women's Interagency Health Study
  • Attendee of UPMC HIV/AIDS Program

You may not qualify if:

  • Acute onset of shortness of breath, cough, fever or heart condition such as tachycardia, angina or arrhythmias
  • Pregnancy
  • MI, CVA or cardiovascular event within last 3 months
  • Eye or abdominal surgery with last 3 months
  • Active TB by documentation or self-report
  • Weight \> 500 lbs.
  • Exposure to \> 10 rads in the previous 12 months (i.e., 2 CT or 4 cardiac cath…or other fluoroscopic exams For bronchoscopy subjects only
  • Subjects with an upper or lower respiratory tract infection
  • Individuals with a Primary diagnosis of vocal cord dysfunction, or those with significant or uncontrolled systemic diseases will be excluded
  • years of age or older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Montefiore Hospital, CTRC MUH, Keystone Bldg.

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Gingo MR, Nouraie M, Kessinger CJ, Greenblatt RM, Huang L, Kleerup EC, Kingsley L, McMahon DK, Morris A. Decreased Lung Function and All-Cause Mortality in HIV-infected Individuals. Ann Am Thorac Soc. 2018 Feb;15(2):192-199. doi: 10.1513/AnnalsATS.201606-492OC.

    PMID: 29313714DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, sputum, oral wash, bronchial washes

MeSH Terms

Conditions

Lung DiseasesEmphysemaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveChronic DiseaseDisease Attributes

Study Officials

  • Alison Morris-Gimbel, MD, MS

    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

February 21, 2011

First Posted

March 31, 2011

Study Start

January 1, 2009

Primary Completion

January 1, 2016

Study Completion

April 1, 2016

Last Updated

August 26, 2025

Record last verified: 2016-05

Locations

US(2)