SarcoidosisGRADSNCT02134717
Impact of Chemokine Receptor 5 (CCR5) Inhibition on Sarcoidosis Immunophenotypes
A study testing all subjects will receive maraviroc 300mg orally twice a day for 6 weeks, Bronchoscopy with bronchoalveolar lavage and venipunctures in people with Sarcoidosis, run by Kevin F. Gibson at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- all subjects will receive maraviroc 300mg orally twice a day for 6 weeks, Bronchoscopy with bronchoalveolar lavage and venipunctures
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Dorothy P. and Richard P. Simmons center for Interstitial lung Disease at the University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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
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.
Read the detailed description
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.
- Conditions
- Sarcoidosis
- Being tested
- all subjects will receive maraviroc 300mg orally twice a day for 6 weeks, Bronchoscopy with bronchoalveolar lavage, venipunctures, Skin biopsy
- Keywords
- sarcoidosis, CCR5 inhibition, maraviroc
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
all subjects will receive maraviroc 300mg orally twice a day for 6 weeksDrug
Also called maraviroc, selzentry
Bronchoscopy with bronchoalveolar lavageProcedure or surgery
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.
venipuncturesProcedure or surgery
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 biopsyProcedure or surgery
For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: all subjects will receive maraviroc 300mg orally twice a day for 6 weeks; Procedure: Bronchoscopy with bronchoalveolar lavage; Procedure: venipunctures; Procedure: Skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (2)
Mononuclear Cell (MNC) Activation and T-cell Differentiation
MNC activation and T-cell differentiation before and after CCR5 inhibition.
Measured: 6 weeks
Chemokine Receptor 5 (CCR5) Expression Among These Immune Effector Cells
CCR5 expression among these immune effector cells before and after CCR5 inhibition.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kevin F. Gibson
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh
- Responsible party
- Sponsor-investigator, Kevin F. Gibson, University of Pittsburgh
- Investigators
- Kevin F Gibson, MD, Principal investigator, DorothyP. and Richard P. SImmons Center for Interstitial Lung Disease at the University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134717
- Sponsor's protocol ID
- U01HL112711
- Acronym
- GRADS
- Status last verified
- Nov 2025
- First submitted
- 30 Apr 2014
- Last updated
- 3 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02134717
- Acronym / sponsor ID
- GRADS / U01HL112711
- Conditions
- Sarcoidosis
- Keywords
- sarcoidosis, CCR5 inhibition, maraviroc
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Kevin F. GibsonUniversity, hospital or other
- Collaborators
- University of Pittsburgh
- Study start
- Jan 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 May 2014 (estimated)
- Results
- Posted 18 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sarcoidosis stage II | Experimental | Drug: all subjects will receive maraviroc 300mg orally twice a day for 6 weeks, Procedure: Bronchoscopy with bronchoalveolar lavage, Procedure: venipunctures, Procedure: Skin biopsyAll 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| all subjects will receive maraviroc 300mg orally twice a day for 6 weeksAlso: maraviroc, selzentry | Drug | sarcoidosis stage II |
| Bronchoscopy with bronchoalveolar lavageBronchoscopy 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. | Procedure or surgery | sarcoidosis stage II |
| venipuncturesVenipunctures 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 or surgery | sarcoidosis stage II |
| Skin biopsyFor subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies. | Procedure or surgery | sarcoidosis stage II |
Primary outcome
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
2 secondary outcomes
Mononuclear Cell (MNC) Activation and T-cell Differentiation
Time frame: 6 weeks
Chemokine Receptor 5 (CCR5) Expression Among These Immune Effector Cells
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin F Gibson, MD principal investigator
DorothyP. and Richard P. SImmons Center for Interstitial Lung Disease at the University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing all subjects will receive maraviroc 300mg orally twice a day for 6 weeks, Bronchoscopy with bronchoalveolar lavage and venipunctures in people with Sarcoidosis, run by Kevin F. Gibson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cell Count and Differentials in Blood and Bronchoalveolar Lavage Fluid Pre- and Post Maraviroc (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.