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

N/A
Waitlist Available
Led By Alison Morris, MD, MS
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Lung Disease
  • HIV/AIDS
  • Chronic Obstructive Pulmonary Disease
  • Aging

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Measurement of the inflammome in HIV-associated lung disease.
Number of HIV COPD patients with increased immune cell and lung cellular aging.
Number of HIV+ individuals with increased lung dysfunction disproportionate to age.
Secondary study objectives
Senility
The number of lung epithelial cell senescence in HIV+ individuals.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: HIV positive under 50yoExperimental Treatment3 Interventions
PFT's, lab work, 6MWT, questionnaires, at baseline 18months and 36 months.
Group II: HIV positive over 50yoExperimental Treatment4 Interventions
PFT's, lab work, 6MWT, questionnaires, at baseline 18months and 36 months.
Group III: HIV negative under 50 yoExperimental Treatment4 Interventions
PFT's, lab work, 6MWT, questionnaires, at baseline 18months and 36 months.
Group IV: HIV negative over 50yoExperimental Treatment4 Interventions
PFT's, lab work, 6MWT, questionnaires, at baseline 18months and 36 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PFT
2014
N/A
~330
lab work
2014
N/A
~330
6MWT
2017
N/A
~630

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,941 Previous Clinical Trials
47,792,596 Total Patients Enrolled
University of PittsburghLead Sponsor
1,790 Previous Clinical Trials
16,359,480 Total Patients Enrolled
Alison Morris, MD, MSPrincipal InvestigatorUniversity of Pittsburgh
3 Previous Clinical Trials
163 Total Patients Enrolled
~27 spots leftby Dec 2025
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