Longitudinal Evaluation of HIV-associated Lung Disease Phenotypes (LEAP)

University of Pittsburgh

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease; HIV; Emphysema

Treatments: Procedure: Lung function testing; Procedure: Six-Minute walk test; Procedure: Echocardiogram; Procedure: questionnaires; Radiation: Quantitative CT scans; Procedure: Nasal secretion and cell collection; Procedure: blood draw

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02238327

1R01HL125049-01 (U.S. NIH Grant/Contract)

PRO14070355

Details and patient eligibility

About

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.

Full 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.

Enrollment: 232 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

232 participants in 2 patient groups

HIV positive normal pulmonary function

Description:

HIV positive DLCO percent predicted \>=.80 FEV1/FVC percent predicted \>=0.70

Treatment:

Procedure: Nasal secretion and cell collection

Procedure: questionnaires

Procedure: blood draw

Radiation: Quantitative CT scans

Procedure: Six-Minute walk test

Procedure: Echocardiogram

Procedure: Lung function testing

HIV positive with pulmonary dysfuntion

Description:

HIV positive DLco percent predicted \<=0.80% FEV1/FVC percent predicted\<=0.70%

Treatment:

Procedure: Nasal secretion and cell collection

Procedure: questionnaires

Procedure: blood draw

Radiation: Quantitative CT scans

Procedure: Six-Minute walk test

Procedure: Echocardiogram

Procedure: Lung function testing