NCT03572335Completed
Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Systems Biology of Diffusion Impairment in HIV--BoDI
Source: ClinicalTrials.gov · Last updated 7 Mar 2025
Brief summary (registry, in English)
Diffusing capacity for carbon monoxide (DLco) abnormalities are common in HIV+ individuals and associated with significant morbidity and mortality. The complexity and the individualized differences in causes of these abnormalities have been challenging to unravel using traditional approaches. In this proposal, the investigators construct a systems' modeling approach to identify novel molecular and clinical pathways contributing to DLco impairment in HIV+ individuals and to determine predictive signatures of DLco decline in order to develop strategies to treat and prevent abnormal lung function in this susceptible population.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 61 (actual)
- First submitted
- 13 Jun 2018
- Start date
- 6 Sept 2018
- Primary completion date
- 1 Oct 2022
- Lead sponsor
- University of Pittsburgh
- NCT number
- NCT03572335
What you commit to
- Study type: Observational
- Participants enrolled: 61
- From 6 Sept 2018 to the primary completion date, 1 Oct 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intravenous drug use or alcohol use that will impair ability to complete study investigations in the opinion of the investigator.
- individuals receiving chronic or acute antibiotics in the prior 4 months.
Other illness
- Contraindication to pulmonary function testing (i.e. abdominal or cataract surgery within 3 months, recent myocardial infarction, etc.).
- 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.
- subjects with an upper or lower respiratory tract infection
Other
- Pregnancy or breast-feeding. (urine pregnancy done on all females of child bearing potential-males and females who are at least 1 year post menopausal or surgically sterile will not be tested)
- Increasing respiratory symptoms or febrile (temperature \>100.40F \[380C\]) within 4 weeks of study entry.
- Acute cardiopulmonary issue in the past 4 months.
Who the study is looking for
- Men and women age 18 to 80
- HIV positive and participated in previous HLRC(HIV Lung Research Center) study (PRO10060177, PRO09050521, PRO14070355, PRO08030011, PRO00606151, PRO13050229, PRO17060077).
- Negative pregnancy test (for women of child barring capabilities).
- Have undergone bronchoscopy with BAL(bronchial lavage) and/or brushing for AECs in storage.
- Receiving ART (Anti-Retroviral Therapy)and virally-suppressed for at least 6 months.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pittsburgh department of medicine division of Pulmonary, Allergy and Critical Care medicine Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.