Longitudinal Evaluation of HIV-associated Lung Disease Phenotypes
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, HIV / AIDS, Pulmonary |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 9/9/2018 |
| Start Date: | September 2014 |
| End Date: | September 2019 |
The Study is a Multicenter, Prospective Observational Study of Pathogenesis of HIV Pulmonary Disease.
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.
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.
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.
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.
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
We found this trial at
1
site
4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Phone: 412-624-8330
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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