Sarcoidosis Clinical Trial
— GRADSOfficial 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
Verified date | January 2018 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 3 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Histologically proven sarcoidosis from any site (noncaseating granulomas without other causes). 2. Diagnosis of active sarcoidosis (Sec. 5.5.4.t) clinical stage II by Chest X-ray (CXR). 3. Forced Vital Capacity (FVC) >45% and Diffusing Capacity for Carbon Monoxide (DLCO) >50% of predicted values. 4. Evidence of active sarcoidosis (see criteria above) 5. Able and willing to complete all study procedures (e.g., bronchoscopy, post-drug surveillance) 6. Age: 18+ years old (prevalence greatest in young adults; pediatric maraviroc safety not established). 7. Not on immunosuppression for sarcoidosis at the time of recruitment, (e.g., steroids, tumor necrosis factor alpha (TNF-a) blockade) 8. Liver function (transaminases, bilirubin), coagulation (International Normalized Ratio (INR), partial thromboplastin time (PTT), platelet count), blood urea nitrogen (BUN), creatinine, and white blood count (WBC) within normal limits. 9. If female: negative pregnancy test, agreement to use reliable contraception if of childbearing potential 30 days prior and for 30 days after study completion (drug safety during pregnancy not established). 10. Negative HIV and HBsAg tests Exclusion Criteria: 1. Diagnosis of infection based upon clinical evaluation and/or microbial testing. 2. The diagnosis of any disease involving the heart, lungs, liver (HVC), kidney, hematologic, endocrine, or Gl systems which, in the judgment of the PI, would pose an undue risk to the subject if they participated in this study. This includes but is not limited to diabetes, uncontrolled hypertension, liver disease (HVC), or history of malignancy. 3. Medications that will either inhibit or induce CYP3A4 (including St John's Wort) |
Country | Name | City | State |
---|---|---|---|
United States | Dorothy P. and Richard P. Simmons center for Interstitial lung Disease at the University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Kevin F. Gibson | University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | 6 weeks | |
Secondary | Mononuclear Cell (MNC) Activation and T-cell Differentiation | MNC activation and T-cell differentiation before and after CCR5 inhibition. | 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. | 6 weeks |
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