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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
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Kevin F. Gibson, University of Pittsburgh

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Sarcoidosis
Interventions Drug: all subjects will receive maraviroc 300mg orally twice a day for 6 weeks
Procedure: Bronchoscopy with bronchoalveolar lavage
Procedure: venipunctures
Procedure: Skin biopsy
Enrollment 3
Recruitment Details Subjects with sarcoidosis stage II and active disease
Pre-assignment Details Willing to undergo two Bronchoalveolar lavages
Arm/Group Title Sarcoidosis Stage II
Hide Arm/Group Description

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.

all subjects will receive maraviroc 300mg orally twice a day for 6 weeks

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: 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.

Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies.

Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title Sarcoidosis Stage II
Hide Arm/Group Description

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.

all subjects will receive maraviroc 300mg orally twice a day for 6 weeks

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: 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.

Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies.

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants
37
(23 to 58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
2
  66.7%
Male
1
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Total Cell Count and Differentials in Blood and Bronchoalveolar Lavage Fluid Pre- and Post Maraviroc
Hide Description General indicators of inflammation following chemokine receptor 5 (CCR5) inhibition in blood and bronchoalveolar lavage
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data could not be analyzed
Arm/Group Title Sarcoidosis Stage II
Hide Arm/Group Description:

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.

all subjects will receive maraviroc 300mg orally twice a day for 6 weeks

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: 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.

Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Mononuclear Cell (MNC) Activation and T-cell Differentiation
Hide Description MNC activation and T-cell differentiation before and after CCR5 inhibition.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated before data were collected for this outcome measure.
Arm/Group Title Sarcoidosis Stage II
Hide Arm/Group Description:

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.

all subjects will receive maraviroc 300mg orally twice a day for 6 weeks

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: 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.

Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Chemokine Receptor 5 (CCR5) Expression Among These Immune Effector Cells
Hide Description CCR5 expression among these immune effector cells before and after CCR5 inhibition.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated before data were collected for this outcome measure.
Arm/Group Title Sarcoidosis Stage II
Hide Arm/Group Description:

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.

all subjects will receive maraviroc 300mg orally twice a day for 6 weeks

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: 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.

Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sarcoidosis Stage II
Hide Arm/Group Description

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.

all subjects will receive maraviroc 300mg orally twice a day for 6 weeks

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: 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.

Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies.

All-Cause Mortality
Sarcoidosis Stage II
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Sarcoidosis Stage II
Affected / at Risk (%)
Total   0/3 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sarcoidosis Stage II
Affected / at Risk (%)
Total   0/3 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kevin Gibson MD
Organization: University of Pittsburgh
Phone: 412-624-7095
EMail: gibsonkf@upmc.edu
Layout table for additonal information
Responsible Party: Kevin F. Gibson, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02134717    
Other Study ID Numbers: U01HL112711 ( U.S. NIH Grant/Contract )
First Submitted: April 30, 2014
First Posted: May 9, 2014
Results First Submitted: August 8, 2016
Results First Posted: July 18, 2017
Last Update Posted: February 14, 2018