Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase I Trial of Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis
Brief Summary: This research study is being done to evaluate the safety of BHT-3009 alone and when combined with atorvastatin (Lipitor) in patients with multiple sclerosis (MS).


Options:
A: Inclusion Criteria:

* Is between the age of 18 and 55 years (both included)
* Relapsing-remitting MS according to Poser criteria (CDMS or LSDMS) 22 or definite MS according to McDonald criteria 23
* Disability equivalent to an EDSS of 5.5 or less 21
* Clinical activity defined as at least one reported or documented relapse within the last year
* Patient must be prepared to and considered able to follow the protocol during the whole study period and to attend the planned visits, even if the treatment has to be withdrawn

Exclusion Criteria:

* Any condition that might give rise to similar symptoms as MS
* Immunomodulatory or immunosuppressive treatment for MS prior to inclusion into the study (prior pulse steroid treatment for relapses is allowed)
* Treatment with glucocorticoids or ACTH later than one month prior to inclusion into the study, i.e. at the screening visit
* Onset of a relapse within one month prior to inclusion into the study, i.e. at the screening visit
* History of major depression
* Alcohol or drug dependency
* Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV)
* Significant hypertension (BP \> 180/110 mmHg)
* Renal insufficiency defined as serum creatinine \> 1.5 times the upper normal reference limit
* Total plasma cholesterol \< 3.5 mmol/L
* Any medical illness requiring treatment with systemic corticosteroids
* Any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability
* Women who are pregnant, breast-feeding or have the possibility for pregnancy during the study. To avoid pregnancy, women have to be postmenopausal, surgically sterile, sexually inactive or practice reliable contraception
B: Inclusion Criteria:

* Definite diagnosis of multiple sclerosis by the McDonald criteria.
* Patients with relapsing remitting MS or secondary progressive MS are eligible.
* 1-5 gadolinium enhancing (Gd+) lesions on the first Screening MRI or relapse in the previous 2 years, or disease worsening in the previous 2 years
* Clinically stable for \> 1 month before screening evaluation and during screening. Patients who are stable on approved therapy are eligible only if they have intolerable side effects or other medical reasons for discontinuing approved therapy.
* Off interferon for \> 1 month before screening evaluation.
* Off immunosuppressive and cytotoxic therapy (e.g. mitoxantrone, cladrabine) \>12 months or \> 6 months with CD4 count \> 400.
* EDSS ≥ 2.5 and \< 7.0.
* Female or male, age \> 18 years.
* Able to give informed consent.
* WBC and platelets in normal range, hemoglobin \> 10.0 g/dl.
* AST, ALT, bilirubin \< upper limit of normal.
* Creatinine \< upper limit of normal.
* CPK \< upper limit of normal.

Exclusion Criteria:

* High-dose corticosteroids (e.g. \>500 mg methylprednisolone or equivalent) within previous month.
* \>5 Gd+ lesions on the first Screening MRI.
* Previous vaccine therapy, stem cell transplantation or total lymphoid radiation.
* Glatiramer within previous 12 months.
* Treatment with any statin in the previous 6 months or elevated cholesterol that requires treatment with a statin.
* Pregnant or lactating women.
* Unwilling to use a medically acceptable form of birth control.
* History of positive test for HIV, hepatitis B or hepatitis C.
* Clinically significant ECG abnormalities.
* Medical condition or social circumstances that would in the opinion of the investigator prevent full participation in the trial or evaluation of study endpoints.
* Implanted pacemakers, defibrillators or other metallic objects on or inside the body that limit performing MRI scans.
* History of intolerable adverse events with statin therapy.
C: Inclusion Criteria:

* 18 - 55 years old
* MS diagnosis according McDonald criteria
* Relapsing-remitting MS
* EDSS 0 - 6
* Disease activity as occurrence of CEL in brain MRI
* IFN-beta therapy for at least 6 months

Exclusion Criteria:

* Primary chronic progressive MS
* Symptoms and signs of clinical disease conditions similar to MS
* Conditions that can disturb MRI measurements
* Clinically relevant GI diseases eg Colitis ulcerosa, Crohns disease, history of Ulcus pepticum
* Clinically relevant lung, heart, CNS, infectious disease
* Clinically relevant liver, kidney or bone marrow abnormalities (as defined by specific clinical chemistry values)
* Allergies towards Gd-DTPA
* Allergies towards constituents of the therapeutic agent
* Recruitment to other clinical trials within 6 months prior to or during this study
* Pretreatment with complete lymph irradiation, antibody therapy against lymphocyte populations (eg. anti-CD4, Campath-1H), mitoxantrone, cyclophosphamide, cyclosporin A, human antibodies, all immunomodulatory or immunosuppressive agents including recombinant cytokines or other potential experimental MS therapies (6 months prior to study start), glatiramer acetate, azathioprine, IVIg (6 months prior to study start) pregnancy or lactation
* Alcohol or drug abuse
* Inhibitors of Cytochrom P 450 3A (eg. cyclosporin, macrolide antibiotics, azole antimycotics).
* Medical or psychological conditions that could hamper with the patients capacity to understand patient information, to give the informed consent, to adhere to the protocol of the study and to be able to complete the study
D: Inclusion Criteria:

1. edss\<5
2. \>=1 attack in last year

Exclusion Criteria:

1. \>2 attacks in study
2. drug complication

Answer: B