NCT05502653 Relationship of Inflammation and Pulmonary Function to Fungal Translocation in HIV
| NCT ID | NCT05502653 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | HIV Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-09-01 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigator will study the origin of fungal translocation in HIV, its relationship to the mycobiome, and its relationship to lung function and inflammation. Supported by the preliminary data and published studies, this project is based on the premise that circulating BDG derived from microbial translocation stimulates inflammation and worsens lung function in PWH. Chronic obstructive pulmonary disease (COPD) is a significant public health problem with few therapies that modify disease trajectory. COPD is a leading cause of mortality in the United States associated with increased morbidity and healthcare costs. Long-acting bronchodilators and inhaled corticosteroids are mainstays of therapy that control symptoms and reduce acute exacerbation frequency, but do not have a significant impact on mortality or lung function trajectory. The National Heart, Lung, and Blood Institute's COPD National Action Plan focuses on the critical need for research to characterize COPD risk factors and disease mechanisms in order to improve the understanding of causes and progression of disease. The ultimate goal is to provide precision therapy to appropriate patient subgroups to preserve health or arrest disease progression. Microbial organisms in the gut may have a profound effect on lung disease. The role of the gut-lung axis, defined as the cross-talk between gut microbiota and the lungs, in the pathogenesis of chronic respiratory diseases is emerging as an area of interest. Perturbations of gut microbiota characterized by low microbial diversity and changes in microbiota abundance are linked to childhood asthma risk, airflow obstruction in adult asthma, and severe lung dysfunction in cystic fibrosis. Studies in animals show that both a high fiber diet that modulates gut microbiota and an abundance of beneficial bacterial strains attenuate inflammation, emphysema, and COPD development in response to cigarette smoke exposure in murine models. In humans, recent investigations show differences in the gut microbial communities between COPD patients and healthy individuals as well as shifts in the gut microbiome with acute exacerbations of COPD.
Eligibility Criteria
Inclusion Criteria: * Age 18 to 80 * HIV positive * Virally-suppressed on ART for at least 6 months * subjects enrolled in Dr. Morris's HLRC Studies STUDY20020151, STUDY19080258, STUDY19060243, STUDY19070181, STUDY19070181, STUDY19050326 OR subjects being seen at the HIV/PACT clinics. Exclusion Criteria: * Contraindication to pulmonary function testing (i.e., abdominal or cataract surgery within 3 months, recent myocardial infarction, etc.). * individuals with clinical or radiographic evidence of another significant pulmonary diagnosis (e.g. interstitial lung disease, active asthma) * inflammatory bowel disease * pregnancy * use of antibiotics in the prior 2 weeks * immunomodulators in the prior 6 months * unable to perform any study procedures.
Contact & Investigator
Alison J Morris, MD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT05502653 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05502653 currently recruiting?
Yes, NCT05502653 is actively recruiting participants. Contact the research team at kessingercj@upmc.edu for enrollment information.
Where is the NCT05502653 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT05502653 clinical trial?
NCT05502653 is sponsored by University of Pittsburgh. The principal investigator is Alison J Morris, MD at University of Pittsburgh. The trial plans to enroll 100 participants.
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