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COMPLETED

Longitudinal Evaluation of HIV-associated Lung Disease Phenotypes

The Study is a Multicenter, Prospective Observational Study of Pathogenesis of HIV Pulmonary Disease.

NCT02238327•University of Pittsburgh

Summary

The overall hypotheses of this proposal are that discrete phenotypes of HIV Chronic Obstructive Pulmonary disease (COPD) differ in their trajectories, biomarkers, and risk factors and that persistent viral infection including residual HIV is linked to HIV COPD.

Detailed Description

The study is a multicenter, prospective observational study of pathogenesis of HIV pulmonary disease. We will determine the prevalence and risk factors for lung dysfunction as quantified by pulmonary function testing in HIV+ subjects. We will build on our existing longitudinal cohorts while adjusting for important co-variates such as antiretroviral therapy (ART), smoking history, co-infections, and illicit drug use. Evaluations will be scheduled at baseline, 18 months, and 36 months. (6, 12, 18 and 36 months for ART initiators at the UCSF). Study visits will consist of blood draw, questionnaires, pulmonary function testing, 6-minute walk test, CT of the chest at visit two. Oral specimen collection and glycocalyx and echocardiogram (visit two) at the Pittsburgh site only.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•HIV-1 infection, documented in medical record at any time prior to study entry.
•Men and women age 18 to 80.
•Ability and willingness to complete all tests.
•Participant in HLRC studies, MACS, Women's Interagency Health Study, and local HIV clinics.
•For UCSF only, new ART initiators from Women's Interagency Health Study or the HIV clinic

Exclusion Criteria

•Pregnancy or breast-feeding.
•Contraindication to pulmonary function testing (i.e. abdominal or cataract surgery within 3 months, recent myocardial infarction, etc.).
•Increasing respiratory symptoms or febrile (temperature \>100.40F \[380C\]) within 4 weeks of study entry.
•Hospitalization within 4 weeks prior to study entry (excluding mental health).
•Uncontrolled hypertension at screening visit (systolic \> 180 mm Hg or diastolic \> 100 mm Hg) from an average of two or more readings. Subject may return for screening after blood pressure is controlled.
•Active cancer requiring systemic chemotherapy or radiation.
•Active infection of lungs, brain, or abdomen.
•Intravenous drug use or alcohol use that will impair ability to complete study investigations in the opinion of the investigator

Locations (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

September 1, 2014

Primary Completion Date

March 2, 2020

Completion Date

March 2, 2020

Last Updated

October 8, 2020

Enrollment

232

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary DiseaseHIVEmphysema

Interventions

blood draw

PROCEDURE

questionnaires

PROCEDURE

Lung function testing

PROCEDURE

Six-Minute walk test

PROCEDURE

Quantitative CT scans

RADIATION

Nasal secretion and cell collection

PROCEDURE

Echocardiogram

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 8, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Longitudinal Evaluation of HIV-associated Lung Disease Phenotypes

Inclusion Criteria

Exclusion Criteria

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