Investigating the link between inflammation, lung function, and fungal translocation in HIV patients
Relationship of Fungal Translocation, Inflammation, and Pulmonary Function in HIV
This study is trying to see how inflammation and lung function are related to fungal infections in people living with HIV over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05502653 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the origins of fungal translocation in individuals living with HIV and its connection to the mycobiome, lung function, and inflammation. Participants will undergo a series of assessments, including urine collection for gut barrier integrity, blood sampling for measurement of specific proteins, and pulmonary function tests to evaluate lung capacity and function. The study will track these parameters over baseline, 18 months, and 36 months to understand the relationship between these factors in HIV-positive individuals.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-positive individuals aged 18 to 80 who are virally suppressed on antiretroviral therapy for at least six months.
Not a fit: Patients with significant pulmonary diagnoses, inflammatory bowel disease, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of lung function and inflammation in HIV patients, potentially enhancing their overall health outcomes.
How similar studies have performed: While this study explores a novel relationship, previous studies have indicated potential links between inflammation and lung function in HIV, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Alison J Morris, MD — University of Pittsburgh
- Study coordinator: Cathy J Kessinger
- Email: kessingercj@upmc.edu
- Phone: 412-624-8330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.