Clinical Trial: Impact of CCR5 Inhibition on Sarcoidosis Immunophenotypes

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Interventional Study of the Effect of CCR5 Inhibition With Maraviroc on Immune Cells in the the Lung and in Peripheral Blood of Patients With Sarcoidosis

Brief Summary: The study hypothesizes that inhibition of the receptor CCR5 by maraviroc will diminish inflammation in patients with sarcoidosis. Subjects with active sarcoidosis will first undergo bronchoscopy with bronchoalveolar lavage to recover lung immune cells for baseline analysis. They will then receive the drug maraviroc for 6 weeks duration. They will then undergo a repeat bronchoscopy with bronchoalveolar lavage to recover lung immune cells for analysis following maraviroc treatment.

Detailed Summary: The investigators hypothesize that inhibition of CCR5 by maraviroc may have a beneficial immunomodulatory effect on the granulomatous inflammation of pulmonary sarcoidosis. The specific aim of this proposal is the investigate the effect of CCR5 inhibition on the trafficking of mononuclear cells to the lung, skin, peripheral blood in subjects with active sarcoidosis exposed to the CCR5 inhibitor, maraviroc. A second aim will be to isolate by cell sorting CD4+CCR5+ T cells for amplified gene expression profiling before and after CCR5 inhibition, experiments the investigators believe will elucidate genes associated with downstream activation and inhibition of CCR5 receptor function.
Sponsor: University of Pittsburgh

Current Primary Outcome: Total cell count and differentials in blood and bronchoalveolar lavage fluid pre- and post maraviroc [ Time Frame: 6 weeks ]

General indicators of inflammation following CCR5 inhibition in blood and bronchoalveolar lavage


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mononuclear cell activation and T-cell differentiation [ Time Frame: 6 weeks ]
    MNC activation and T-cell differentiation before and after CCR5 inhibition
  • CCRS expression among these immune effector cells [ Time Frame: 6 weeks ]
    CCRS expression among these immune effector cells before and after CCR5 inhibition


Original Secondary Outcome: Same as current

Information By: University of Pittsburgh

Dates:
Date Received: April 30, 2014
Date Started: January 2014
Date Completion:
Last Updated: January 6, 2016
Last Verified: January 2016