Raltegravir (Isentress) Pilot Study in Relapsing Multiple Sclerosis
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Raltegravir
Intervention description: 400mg twice daily for 3 months
Intervention MeSH terms: Raltegravir Potassium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: raltegravir; MS; RRMS; Charcot Project

Summary:

      The purpose of this study is to determine whether raltegravir is effective in preventing
      progression of relapsing remitting multiple sclerosis as determined by gadolinium- enhanced
      MRI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients between 18-55 years of age.

          -  Diagnosis of MS, according to the revised McDonald Criteria 2010.

          -  EDSS score of 0-6.0 inclusive.

          -  Documented at least one relapse within the past 12 months or at least one Gd-enhanced
             lesion on the brain MRI detected within 3 months prior to screening date

          -  Gd-enhanced lesion on screening MRI (if MRI not used to meet screening criteria
             above).

          -  Female patients of childbearing potential will be expected to be on appropriate
             contraception (hormonal or barrier method of birth control; abstinence) from time of
             consent until 6 weeks after treatment discontinuation. (the repeated administration of
             gadolinium and MRI are not recommended during pregnancy). NOTE: Subjects are
             considered not of child bearing potential if they are surgically sterile (they have
             undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they
             are postmenopausal.

          -  Females of childbearing potential must have a negative urine pregnancy test prior to
             every MRI scan/ within 7 days prior to being registered for protocol therapy.

          -  Must give written informed consent and authorize the release and use of protected
             health information, as required by local law.

          -  Able and willing to undergo blood, saliva and urine sampling at regular intervals as
             defined by the protocol.

          -  Able and willing to receive Gadolinium enhanced MRI's at regular intervals as defined
             by the protocol.

          -  Able to comply with study requirements.

        Exclusion Criteria:

          -  Pregnant or breastfeeding or unwilling to use contraception.

          -  Treatment with immunosuppressive, immunomodulatory or experimental treatments within
             the last 6 months of enrolment in the study, but excluding pulsed intravenous or oral
             steroids for treatment of MS relapse.

          -  No pulsed intravenous or oral steroids in the 30 days preceding the baseline
             assessment.

          -  Patients presenting with medical disorder deemed severe or unstable by the CI such as
             poorly controlled diabetes or arterial hypertension, severe cardiac insufficiency,
             unstable ischemic heart disease, abnormal liver function tests (>2.5 times ULN) and
             abnormal complete blood count (in particular leukopenia, as defined by a lymphocyte
             count <500, neutrophil <1.5 or platelet count < 100, or thrombocytopenia < 1.5 LLN),
             or any medical condition which, in the opinion of the chief investigator, would pose
             additional risk to the patient.

          -  Presence of human immunodeficiency virus antibodies.

          -  Patients receiving proton pump inhibitors (e.g. omeprazole/esomeprazole)

          -  Patients with active hepatitis B or/and C with liver function tests >2.5 times ULN

          -  Exposure to any other investigational drug within 30 days of enrolment in the study.

          -  Prior history of malignancy unless an exception is granted by the Chief Investigator.

          -  History of uncontrolled drug or alcohol abuse within 6 months prior to enrolment into
             the study.

          -  Patients treated with Rifampicin in past four weeks.