Longitudinal Evaluation of HIV-associated Lung Disease Phenotypes

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; HIV; Emphysema
• Interventions: Procedure: blood draw; Procedure: questionnaires; Procedure: Lung function testing; Procedure: Six-Minute walk test; Radiation: Quantitative CT scans; Procedure: Nasal secretion and cell collection; Procedure: Echocardiogram

• Registration Number: NCT02238327
• Lead Sponsor: University of Pittsburgh

Brief 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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-09
• Study First Posted: 2014-09-12
• Primary Completion: 2020-03-02
• Study Completion: 2020-03-02
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV positive normal pulmonary function	Quantitative CT scans	HIV positive DLCO percent predicted \>=.80 FEV1/FVC percent predicted \>=0.70
HIV positive with pulmonary dysfuntion	questionnaires	HIV positive DLco percent predicted \<=0.80% FEV1/FVC percent predicted\<=0.70%
HIV positive normal pulmonary function	blood draw	HIV positive DLCO percent predicted \>=.80 FEV1/FVC percent predicted \>=0.70
HIV positive normal pulmonary function	questionnaires	HIV positive DLCO percent predicted \>=.80 FEV1/FVC percent predicted \>=0.70
HIV positive normal pulmonary function	Lung function testing	HIV positive DLCO percent predicted \>=.80 FEV1/FVC percent predicted \>=0.70
HIV positive with pulmonary dysfuntion	Echocardiogram	HIV positive DLco percent predicted \<=0.80% FEV1/FVC percent predicted\<=0.70%
HIV positive with pulmonary dysfuntion	Lung function testing	HIV positive DLco percent predicted \<=0.80% FEV1/FVC percent predicted\<=0.70%
HIV positive with pulmonary dysfuntion	Quantitative CT scans	HIV positive DLco percent predicted \<=0.80% FEV1/FVC percent predicted\<=0.70%
HIV positive with pulmonary dysfuntion	Nasal secretion and cell collection	HIV positive DLco percent predicted \<=0.80% FEV1/FVC percent predicted\<=0.70%
HIV positive with pulmonary dysfuntion	Six-Minute walk test	HIV positive DLco percent predicted \<=0.80% FEV1/FVC percent predicted\<=0.70%
HIV positive normal pulmonary function	Nasal secretion and cell collection	HIV positive DLCO percent predicted \>=.80 FEV1/FVC percent predicted \>=0.70
HIV positive normal pulmonary function	Six-Minute walk test	HIV positive DLCO percent predicted \>=.80 FEV1/FVC percent predicted \>=0.70
HIV positive normal pulmonary function	Echocardiogram	HIV positive DLCO percent predicted \>=.80 FEV1/FVC percent predicted \>=0.70
HIV positive with pulmonary dysfuntion	blood draw	HIV positive DLco percent predicted \<=0.80% FEV1/FVC percent predicted\<=0.70%

Primary Outcome Measures

Name	Time	Method
differences in the trajectory of FEV1 in clinical COPD phenotypes,	36 months	PFT's at baseline, 18 months and 36months to determine modifying risk factors and relationship of phenotypes to mortality, and delineate the association of ART and lung dysfunction.

Secondary Outcome Measures

Name	Time	Method
will measure biomarkers of these phenotypes and ability to predict HIV COPD	36 months

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States