Clinical trial: Impact of Chemokine Receptor 5 (CCR5) Inhibition on Sarcoidosis Immunophenotypes (NCT02134717)

Eligibility criteria:
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)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs.  She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications.  On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli.

Patient description (patient's own words): I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB.

Does the patient match the trial criteria? Entailment