Longitudinal Evaluation of HIV-associated Lung Disease Phenotypes

CompletedOBSERVATIONAL
Enrollment

232

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

March 2, 2020

Study Completion Date

March 2, 2020

Conditions
Chronic Obstructive Pulmonary DiseaseHIVEmphysema
Interventions
PROCEDURE

blood draw

Blood will be drawn for plasma, serum, and PBMCs. Clinical labs drawn will be for hepatitis, CMV, hemoglobin and carboxyhemoglobin.

PROCEDURE

questionnaires

The following questionnaires are administered to participants by study personnel at each visit: LEAP questionnaire, St. George's, and MMRC.

PROCEDURE

Lung function testing

The routine lung function endpoints of FVC, FEV1, FEV1/FVC, and FEF25-75% will be measured before and after bronchodilator administration (4 puffs of albuterol). The best of three reproducible forced expiratory attempts is used in analysis. Percent- predicted spirometric values are based on age, height, gender, and ethnicity. DLco will be measured using the automated single-breath procedure of the integrated testing system, which conforms to ATS standards. DLco will be adjusted for hemoglobin and carboxyhemoglobin.

PROCEDURE

Six-Minute walk test

Six-minute walk tests are performed in a 100 foot (30.48 m) segment of straight hallway marked at 10 foot (3 m) intervals. In addition to the usual ATS protocol, the patient is monitored, when available, with Bluetooth wireless pulse oximetry and the time and distance recorded after six minutes and if they desaturate to \<88%. Dyspnea (Borg 0-10) and perceived exertion (Borg 6-20) scales are completed at the beginning and the end of test.

RADIATION

Quantitative CT scans

Subjects will undergo a standard chest CT. The CT scans will use a phantom shipped between sites to standardize results and capture contiguous volume scans acquired at slice thicknesses of 5.0 mm in the axial plane and reconstructed with 512 x 512 pixel matrices. CT examinations will encompass the entire thorax and be performed during a breath-hold at end-inspiration. We will measure % of lung tissue below a threshold for emphysema (i.e. -950 Hounsfield units). Measurements have been histologically-verified and give reproducible measurements. The data set is assembled and analyzed with the image data anonymized.

PROCEDURE

Nasal secretion and cell collection

Participants will be instructed to blow their nose to remove accumulated mucus. Two sprays of commercially available nasal saline will be instilled in each nostril. The participant will then be ask to exhale through the rinsed nostril into a specimen cup. We will repeat this up to 5 times on each side depending on the participants' tolerance to the procedure. Using an otoscope, a small curette will then be used to collect 3 to 5 samples of nasal cells from each nostril. These samples will be used immediately for analysis or banked for future study.

PROCEDURE

Echocardiogram

The cardiac ultrasound will use standard ultrasound techniques to image two-dimensional slices of the heart using 3D real-time imaging.

Trial Locations (1)

15213

University of Pittsburgh, Pittsburgh

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

University of Pittsburgh

OTHER

NCT02238327 - Longitudinal Evaluation of HIV-associated Lung Disease Phenotypes | Biotech Hunter | Biotech Hunter