HIV InfectionsBoDINCT03572335
Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
An observational study of HIV Infections and Pulmonary Disease, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV Infections, Pulmonary Disease
- What is being tested?
- PFT's (pulmonary function testing)
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2018to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18-80 year old men and women who are HIV positive. All will be pulled from previous HIV/Lung studies done by the same PI
Who may be able to join
- 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.
Who cannot join
- 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)
- 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.
- Acute cardiopulmonary issue in the past 4 months.
- 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.
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- 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.
- subjects with an upper or lower respiratory tract infection
- individuals receiving chronic or acute antibiotics in the prior 4 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh department of medicine division of Pulmonary, Allergy and Critical Care medicine
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Systems Biology of Diffusion Impairment in HIV--BoDI
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.
Read the 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.
- Conditions
- HIV Infections, Pulmonary Disease
- Being tested
- PFT's (pulmonary function testing)
- Keywords
- HIV, emphysema, diffusing capacity, chronic obstructive pulmonary disease(COPD)
- Medical subject headings
- HIV Infections, Lung Diseases, Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFT's (pulmonary function testing)Diagnostic test
Also called 6MWT (6 minute walk test)
The routine lung function endpoints of FVC(forced vital capacity), FEV1, FEV1/FVC, and FEF25-75% will be measured with the flow-volume loop recorder before and after bronchodilator administration. The system is calibrated for body temperature and pressure of saturated gas and volumes, per American Thoracic Society (ATS) standards . DLco will be measured using the automated single-breath procedure of the integrated testing system, which conforms with ATS standards.
| Study group | Role | What they receive |
|---|---|---|
| HIV positive with normal PFT's | HIV positive with normal baseline DLco. Subjects with DLco>80% predicted after adjustments for Hgb and Co Receives: Diagnostic Test: PFT's (pulmonary function testing) | |
| HIV positive with mild DLco impairment | HIV positive with mild DLco impairment DLco <80% predicted after adjustments for Hgb and Co. Receives: Diagnostic Test: PFT's (pulmonary function testing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify key causal molecular pathways of DLco impairment.
elucidating complex associations and causal relationships between clinical characteristics, the host inflammatory response, cellular metabolism, the microbiome, and miRNAs.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start6 Sep 2018
- Primary completion1 Oct 2022
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alison Morris, University of Pittsburgh
- Investigators
- Alison Morris, MD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572335
- Sponsor's protocol ID
- STUDY19050326
- Acronym
- BoDI
- Status last verified
- Aug 2024
- First submitted
- 13 Jun 2018
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Biology of Diffusion Impairment in HIV--BoDI
- ClinicalTrials.gov ID
- NCT03572335
- Acronym / sponsor ID
- BoDI / STUDY19050326
- Conditions
- HIV Infections, Pulmonary Disease
- Keywords
- HIV, emphysema, diffusing capacity, chronic obstructive pulmonary disease(COPD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 28 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV positive with normal PFT's | – | Diagnostic Test: PFT's (pulmonary function testing)HIV positive with normal baseline DLco. Subjects with DLco>80% predicted after adjustments for Hgb and Co |
| HIV positive with mild DLco impairment | – | Diagnostic Test: PFT's (pulmonary function testing)HIV positive with mild DLco impairment DLco <80% predicted after adjustments for Hgb and Co. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18-80 year old men and women who are HIV positive. All will be pulled from previous HIV/Lung studies done by the same PI
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
- 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.
- Acute cardiopulmonary issue in the past 4 months.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFT's (pulmonary function testing)Also: 6MWT (6 minute walk test)The routine lung function endpoints of FVC(forced vital capacity), FEV1, FEV1/FVC, and FEF25-75% will be measured with the flow-volume loop recorder before and after bronchodilator administration. The system is calibrated for body temperature and pressure of saturated gas and volumes, per American Thoracic Society (ATS) standards . DLco will be measured using the automated single-breath procedure of the integrated testing system, which conforms with ATS standards. | Diagnostic test | HIV positive with mild DLco impairment, HIV positive with normal PFT's |
Primary outcome
Identify key causal molecular pathways of DLco impairment.
Time frame: 3 years
elucidating complex associations and causal relationships between clinical characteristics, the host inflammatory response, cellular metabolism, the microbiome, and miRNAs.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Morris, MD, MS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Pulmonary Disease, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify key causal molecular pathways of DLco impairment. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.