Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT03572335
Status:
COMPLETED
Last Update Posted:
2025-03-07
First Post:
2018-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Systems Biology of Diffusion Impairment in HIV--BoDI
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BoDI
Brief Summary:
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.
Detailed Description:
Mechanisms of impairment of diffusing capacity for carbon monoxide (DLco), which affects over 50 percent of HIV+ individuals, are poorly understood. No therapies exist despite significant impact on quality of life and mortality. Identifying molecular pathways of DLco impairment in HIV+ individuals and developing ability to predict HIV+ individuals at risk of DLco impairment is thus of utmost importance for improving care. In this proposal, the investigators construct a systems' modeling approach to identify molecular and clinical pathways contributing to DLco impairment in HIV+ individuals. The investigators collect multiple parallel molecular datasets integrated with detailed pulmonary function, radiographic, and echocardiographic measurements to build a comprehensive, systems level model of DLco abnormalities in HIV and to develop predictive models of susceptibility to DLco worsening. As our preliminary data suggest that certain micro ribonucleic acid (miRNAs), such as the hypoxia-induced and metabolically active gene (miR-210), may play an important role in DLco abnormalities in HIV, the investigators then perform hypothesis-testing experiments to determine the impact of miRNAs on lung epithelial and endothelial cells. The investigators will utilize a well phenotyped cohort of over 500 HIV+ individuals with associated biospecimens to execute the aims.
Participants identified to already have specimens available will be scheduled to have PFT testing, bronchoscopy including bronchial wash with brushes and blood collection.
Participants identified to already have specimens available will be scheduled to have PFT testing, bronchoscopy including bronchial wash with brushes and blood collection.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: