Translation Evaluation of Aging, Inflammation and HIV in Lung Function (TEAL)
TEAL
2 other identifiers
observational
323
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 7, 2014
CompletedFirst Posted
Study publicly available on registry
June 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2020
CompletedOctober 8, 2020
October 1, 2020
6.1 years
April 7, 2014
October 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of HIV+ individuals with increased lung dysfunction disproportionate to age.
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. We 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.
2 years
Number of HIV COPD patients with increased immune cell and lung cellular aging.
We will attempt to proved the hypothesis that immune cell and lung cellular aging are increased in HIV COPD.We will examine telomere length and senescence markers in peripheral immune cells, lung immune cells and in lung epithelial cells and will test the hypothesis that HIV+ individuals with worse lung function and faster pulmonary decline manifest a greater degree of immune activation and cellular senescence.
3 yrs
Measurement of the inflammome in HIV-associated lung disease.
We will use this cohort to evaluate biomarkers of inflammation such as IL-6, IL-8, TNF-alpha, and hsCRP to determine if we can identify specific HIV COPD phenotypes using novel decision tree analyses. We will examine relationship of the inflammatory signature associated with COPD to aging markers in Aim 2, as well as ART effects, co-infections, degree of immunosuppression, and other co-variates.
4 years
Secondary Outcomes (2)
Measurement of Pulmonary immune cell senescence in HIV+ individuals with poor lung function.
4 years
The number of lung epithelial cell senescence in HIV+ individuals.
4 years
Study Arms (4)
HIV positive under 50yo
PFT's, lab work, 6MWT, questionnaires, at baseline 18months and 36 months.
HIV negative under 50 yo
PFT's, lab work, 6MWT, questionnaires, at baseline 18months and 36 months.
HIV positive over 50yo
PFT's, lab work, 6MWT, questionnaires, at baseline 18months and 36 months.
HIV negative over 50yo
PFT's, lab work, 6MWT, questionnaires, at baseline 18months and 36 months.
Interventions
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.
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.
The six-minute walk tests are performed in a 100-foot segment of straight hallway marked at 1-foot intervals.
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
Eligibility Criteria
Participants will be subjects in the Pitt Men's Study or the PACT clinic.
You may qualify if:
- 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.
- Uncontrolled hypertension at screening visit (systolic \> 160 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.
You may not qualify if:
- HIV+ young:
- HIV-1 infection, documented in medical record at any time prior to study entry.
- Men and women age 45 years and below.
- Ability and willingness to complete all tests.
- Participant in MACS, Women's Interagency Health Study and secondarily clinics and the community
- HIV+ old:
- HIV-1 infection, documented in medical record at any time prior to study entry.
- Men and women age 50 years and above.
- Ability and willingness to complete all tests.
- Participant in MACS, Women's Interagency Health Study and secondarily clinics and the community
- HIV- young:
- HIV-uninfected, documented at most recent MACS or WIHS visit.
- Men and women age 45 years and below.
- Ability and willingness to complete all tests.
- Participant in MACS, Women's Interagency Health Study and secondarily clinics and the community
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (3)
Drummond MB, Huang L, Diaz PT, Kirk GD, Kleerup EC, Morris A, Rom W, Weiden MD, Zhao E, Thompson B, Crothers K. Factors associated with abnormal spirometry among HIV-infected individuals. AIDS. 2015 Aug 24;29(13):1691-700. doi: 10.1097/QAD.0000000000000750.
PMID: 26372280BACKGROUNDQin S, Clausen E, Nouraie SM, Kingsley L, McMahon D, Kleerup E, Huang L, Ghedin E, Greenblatt RM, Morris A. Tropheryma whipplei colonization in HIV-infected individuals is not associated with lung function or inflammation. PLoS One. 2018 Oct 4;13(10):e0205065. doi: 10.1371/journal.pone.0205065. eCollection 2018.
PMID: 30286195BACKGROUNDGingo MR, Nouraie M, Kessinger CJ, Greenblatt RM, Huang L, Kleerup EC, Kingsley L, McMahon DK, Morris A. Decreased Lung Function and All-Cause Mortality in HIV-infected Individuals. Ann Am Thorac Soc. 2018 Feb;15(2):192-199. doi: 10.1513/AnnalsATS.201606-492OC.
PMID: 29313714BACKGROUND
Biospecimen
Saliva, blood, bronchial wash
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alison Morris, MD, MS
University of Pittsburgh
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 7, 2014
First Posted
June 3, 2014
Study Start
February 1, 2014
Primary Completion
March 2, 2020
Study Completion
March 2, 2020
Last Updated
October 8, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share