Impact of Chemokine Receptor 5 (CCR5) Inhibition on Sarcoidosis Immunophenotypes

NCT02134717 | Terminated Results DMC

• 1 other identifier: U01HL112711
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoidosis

Keywords

sarcoidosis; CCR5 inhibition; maraviroc

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mononuclear Cell (MNC) Activation and T-cell Differentiation

  6 weeks

• Chemokine Receptor 5 (CCR5) Expression Among These Immune Effector Cells

  6 weeks

Study Arms (1)

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.

Drug: all subjects will receive maraviroc 300mg orally twice a day for 6 weeks; Procedure: Bronchoscopy with bronchoalveolar lavage; Procedure: venipunctures; Procedure: Skin biopsy

Interventions

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.

sarcoidosis stage II

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.

sarcoidosis stage II

Skin biopsy PROCEDURE

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

sarcoidosis stage II

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

Also known as: maraviroc, selzentry

sarcoidosis stage II

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven sarcoidosis from any site (noncaseating granulomas without other causes).
• Diagnosis of active sarcoidosis (Sec. 5.5.4.t) clinical stage II by Chest X-ray (CXR).
• Forced Vital Capacity (FVC) \>45% and Diffusing Capacity for Carbon Monoxide (DLCO) \>50% of predicted values.
• Evidence of active sarcoidosis (see criteria above)
• Able and willing to complete all study procedures (e.g., bronchoscopy, post-drug surveillance)
• Age: 18+ years old (prevalence greatest in young adults; pediatric maraviroc safety not established).
• Not on immunosuppression for sarcoidosis at the time of recruitment, (e.g., steroids, tumor necrosis factor alpha (TNF-a) blockade)
• 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.
• 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).
• Negative HIV and HBsAg tests

You may not qualify if:

• Diagnosis of infection based upon clinical evaluation and/or microbial testing.
• 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.
• Medications that will either inhibit or induce CYP3A4 (including St John's Wort)

Sponsors & Collaborators

• Kevin F. Gibson: lead
• University of Pittsburgh: collaborator

Study Sites (1)

Dorothy P. and Richard P. Simmons center for Interstitial lung Disease at the University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Sarcoidosis

Interventions

Maraviroc; Bronchoalveolar Lavage; Phlebotomy

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutic Irrigation; Investigative Techniques; Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative

Limitations and Caveats

This study was terminated due to inadequate funding to complete the recruitment and analysis.

Results Point of Contact

• Title: Kevin Gibson MD
• Organization: University of Pittsburgh

gibsonkf@upmc.edu

412-624-7095

Study Officials

• Kevin F Gibson, MD

  DorothyP. and Richard P. SImmons Center for Interstitial Lung Disease at the University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 9, 2014
• Study Start: January 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 3, 2025
• Results First Posted: July 18, 2017

Record last verified: 2025-11

Locations

US (1)