Not provided
Not provided
Not provided
Not provided
Poor recruitment
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 cluster of differentiation 4 (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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sarcoidosis stage II | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| all subjects will receive maraviroc 300mg orally twice a day for 6 weeks | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Cell Count and Differentials in Blood and Bronchoalveolar Lavage Fluid Pre- and Post Maraviroc | General indicators of inflammation following chemokine receptor 5 (CCR5) inhibition in blood and bronchoalveolar lavage | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mononuclear Cell (MNC) Activation and T-cell Differentiation | MNC activation and T-cell differentiation before and after CCR5 inhibition. | 6 weeks |
| Chemokine Receptor 5 (CCR5) Expression Among These Immune Effector Cells |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kevin F Gibson, MD | DorothyP. and Richard P. SImmons Center for Interstitial Lung Disease at the University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dorothy P. and Richard P. Simmons center for Interstitial lung Disease at the University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
Willing to undergo two Bronchoalveolar lavages
Subjects with sarcoidosis stage II and active disease
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This study was terminated due to inadequate funding to complete the recruitment and analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | This study was terminated due to inadequate funding to complete the recruitment and analysis. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Cell Count and Differentials in Blood and Bronchoalveolar Lavage Fluid Pre- and Post Maraviroc | General indicators of inflammation following chemokine receptor 5 (CCR5) inhibition in blood and bronchoalveolar lavage | Data could not be analyzed | Posted | 6 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
Not provided
Not provided
This study was terminated due to inadequate funding to complete the recruitment and analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Gibson MD | University of Pittsburgh | 412-624-7095 | gibsonkf@upmc.edu |
Not provided
| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077592 | Maraviroc |
| D018893 | Bronchoalveolar Lavage |
| D018962 | Phlebotomy |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bronchoscopy with bronchoalveolar lavage | Procedure | 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 | Procedure | 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 | Procedure | For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies. |
|
CCR5 expression among these immune effector cells before and after CCR5 inhibition.
| 6 weeks |
This study was terminated due to inadequate funding to complete the recruitment and analysis.
| Count of Participants |
| Participants |
|
| Age, Continuous | This study was terminated due to inadequate funding to complete the recruitment and analysis. | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | This study was terminated due to inadequate funding to complete the recruitment and analysis. | Number | participants |
|
|
|
| Secondary | Mononuclear Cell (MNC) Activation and T-cell Differentiation | MNC activation and T-cell differentiation before and after CCR5 inhibition. | Study was terminated before data were collected for this outcome measure. | Posted | 6 weeks |
|
|
| Secondary | Chemokine Receptor 5 (CCR5) Expression Among These Immune Effector Cells | CCR5 expression among these immune effector cells before and after CCR5 inhibition. | Study was terminated before data were collected for this outcome measure. | Posted | 6 weeks |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
Not provided
Not provided
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007507 | Therapeutic Irrigation |
| D008919 | Investigative Techniques |
| D001800 | Blood Specimen Collection |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |