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

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.

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)