NCT05502653: RIFFT

Relationship of Inflammation and Pulmonary Function to Fungal Translocation in HIV

Recruiting now Last updated 12 September 2025

What this trial tests

trial in HIV Infections in 100 participants. Currently enrolling.

Timeline

1 September 2022

Primary endpoint
1 August 2026

1 August 2027

Quick facts

Lead sponsor	University of Pittsburgh
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	100
Start date	1 September 2022
Primary completion	1 August 2026
Estimated completion	1 August 2027
Sites	1 location across United States

Conditions studied

• HIV Infections — all drugs for HIV Infections →
• Inflammation — all drugs for Inflammation →
• COPD — all drugs for COPD →

Sponsor

University of Pittsburgh

Who can join

Adults 18 to 80, any sex, with HIV Infections or Inflammation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.