Impact of Chemokine Receptor 5 (CCR5) Inhibition on Sarcoidosis Immunophenotypes (GRADS)
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|ClinicalTrials.gov Identifier: NCT02134717|
Recruitment Status : Terminated (Poor recruitment)
First Posted : May 9, 2014
Results First Posted : July 18, 2017
Last Update Posted : February 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sarcoidosis||Drug: all subjects will receive maraviroc 300mg orally twice a day for 6 weeks Procedure: Bronchoscopy with bronchoalveolar lavage Procedure: venipunctures Procedure: Skin biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|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|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Experimental: sarcoidosis stage II
All subjects with active stage II sarcoidosis with or without skin disease will receive the drug maraviroc 300mg to be taken orally twice a day for 6 weeks duration.
Drug: all subjects will receive maraviroc 300mg orally twice a day for 6 weeks
Procedure: Bronchoscopy with bronchoalveolar lavage
Bronchoscopy employs a flexible instrument that is inserted into the trachea and proximal airways after topical anesthesia. Bronchoalveolar lavage involves the instillation of saline solution through the bronchoscope into the airways followed by recovery under suction to collects lung fluid containing cells and proteins.
Venipunctures will be performed at study entry, after two weeks, and at the end of the study to collect blood for research studies and safety laboratories.
Procedure: Skin biopsy
For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies.
- Total Cell Count and Differentials in Blood and Bronchoalveolar Lavage Fluid Pre- and Post Maraviroc [ Time Frame: 6 weeks ]General indicators of inflammation following chemokine receptor 5 (CCR5) inhibition in blood and bronchoalveolar lavage
- Mononuclear Cell (MNC) Activation and T-cell Differentiation [ Time Frame: 6 weeks ]MNC activation and T-cell differentiation before and after CCR5 inhibition.
- Chemokine Receptor 5 (CCR5) Expression Among These Immune Effector Cells [ Time Frame: 6 weeks ]CCR5 expression among these immune effector cells before and after CCR5 inhibition.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134717
|United States, Pennsylvania|
|Dorothy P. and Richard P. Simmons center for Interstitial lung Disease at the University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Kevin F Gibson, MD||DorothyP. and Richard P. SImmons Center for Interstitial Lung Disease at the University of Pittsburgh|