Translation Evaluation of Aging, Inflammation and HIV in Lung Function (TEAL)

NCT02154880 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 323

Last updated 2020-10-08

No results posted yet for this study

Summary

Hypothesis;Aging modifies the risk of pulmonary dysfunction in HIV+ individuals.

The study is a multicenter, prospective observational study of aging and pulmonary function in HIV. The investigator will determine the prevalence and risk factors for lung dysfunction as quantified by pulmonary function testing in both younger (\<50 years) and older (≥50 years) HIV+ and HIV-uninfected controls. The investigator will build on existing cohorts and enrich enrollment for individuals over the age of 50 while adjusting for important co-variates such as ART, smoking history, co-infections, and illicit drug use. Evaluations will be scheduled at baseline, 18 months, and 36 months. Study visits will consist of blood draw, questionnaires, and pulmonary function testing.

Conditions

Interventions

PROCEDURE

PFT

Lung function endpoints of FVC, FEV1, FEV1/FVC, and FEF25-75% will be measured with the flow-volume loop recorder on a NDD EasyOne Pro system before and after bronchodilator administration.

PROCEDURE

lab work

The blood will be processed for serum, plasma, and PBMCS, and a portion stored to be used for future use. A hemoglobin and Carboxyhemoglobin will be done in order to calculate the DLCO.

PROCEDURE

6MWT

The six-minute walk tests are performed in a 100-foot segment of straight hallway marked at 1-foot intervals.

OTHER

questionnaires

TEAL, MMRC and ST. George's Questionnaire will be administered. They are paper questionnaires that inquire about respiratory symptoms, quality of life, smoking history and other health issues

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Alison Morris, MD, MS · University of Pittsburgh

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2020-03-02
Completion
2020-03-02

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02154880 on ClinicalTrials.gov