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Trial record 80 of 703 for:    lupus AND Lupus Erythematosus, Systemic

Nelfinavir in Systemic Lupus Erythematosus (NISLE)

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ClinicalTrials.gov Identifier: NCT02066311
Recruitment Status : Completed
First Posted : February 19, 2014
Last Update Posted : July 27, 2018
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Meggan Mackay, Northwell Health

Brief Summary:

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease in which the body's immune system attacks different parts of the body. SLE is characterized by inflammation that leads to tissue damage in different organ systems. Any organ system may be involved, including the skin, the joints, the kidneys, the nervous system, the heart, the lungs, and the blood. The exact cause of SLE is not known. Patients with SLE often have elevated levels of anti-double stranded DNA antibodies. These levels are often associated with disease flares and disease severity. These antibodies can bind to tissue leading to organ damage. Preventing these antibodies from binding to their targets may help decrease disease activity.

Protease inhibitors are medications that have been approved by the Food and Drug Administration (FDA) for use in the treatment of HIV (human immunodeficiency virus). Nelfinavir (also called viracept) is one of these protease inhibitors. Separate from their anti-viral effects, protease inhibitors have been found to decrease inflammation. These medications have been shown to interfere with binding of anti-double stranded DNA antibodies to their targets and may decrease inflammation in SLE. This research study tests whether the protease inhibitor, nelfinavir, will decrease anti-double stranded DNA antibody binding and decrease disease activity.


Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Nelfinavir Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nelfinavir in Systemic Lupus Erythematosus: A Pilot Phase IIa Clinical Trial
Study Start Date : September 2014
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: nelfinavir
Nelfinavir tablets will be taken by oral administration, 750mg (three 250 mg tablets) three times a day
Drug: Nelfinavir
Other Name: Viracept




Primary Outcome Measures :
  1. inhibition of anti-dsDNA binding [ Time Frame: change in anti-dsDNA antibody binding from baseline to Day 56 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is capable of providing written informed consent
  2. Subject is ≥ 18 years old and ≤ 65 years old
  3. Meets at least 4 of 11 modified American College of Rheumatology (ACR) (1997) Revised Criteria for the Classification of Systemic Lupus Erythematosus
  4. Has mild to moderate disease activity defined as

    • A minimum SLEDAI score of 2 excluding points for serology (anti-dsDNA antibody and complement)
    • No active renal or nervous system disease
    • No BILAG A in any organ system
    • No expectation by the investigator that corticosteroids will need to be added or doses increased during the 8 week treatment period for any reason
    • No expectation by the investigator that immunosuppressive medication will need to be added or doses increased during the 8 week treatment period
  5. Has elevated titers of anti-ds DNA antibody at the time of screening (defined as the titer that meets criteria for "high" in the Core Laboratory at the North Shore/LIJ Health Systems; unequivocal high titer as opposed to borderline, indeterminate or intermediate).
  6. Has elevated titers of cross-reactive anti-DNA/DWEYS antibodies at the time of screening (the assays for anti-DNA/DWEYS antibodies will be performed in Dr. B. Diamond's laboratory; study sites will be notified of results within 3 days of receipt of the samples).
  7. If on glucocorticoids, the dose must be ≤10 mg daily and stable for the 4 weeks prior to screening and baseline
  8. If on immunosuppressive or immunomodulatory medication such as azathioprine, methotrexate, leflunomide, mycophenolate, or hydroxychloroquine, the dose must have been stable for the 3 months prior to screening, and expected to remain stable over the course of the study.
  9. Males and females with potential for reproduction must agree to practice effective birth control measures (2 approved methods of contraception). Nelfinavir can decrease serum levels of oral contraceptives; the slightly increased risk of pregnancy due to an interaction between oral contraception and nelfinavir will be discussed when appropriate and the requirement for a second approved method of contraception will be addressed.

Exclusion Criteria:

  1. Current or prior treatment with rituximab, belimumab or anti-CD22 monoclonal antibody in the 12 months prior to this study or any other biologic agent for 90 days prior to this study
  2. Treatment with cyclophosphamide within the 6 months prior to screening
  3. Increase in glucocorticoid dose within 4 weeks of screening or addition of a DMARD in the three months prior to study
  4. A history of drug or alcohol abuse within the 6 months prior to screening
  5. Elevated LFT's:

    • ALT or AST ≥ 2 x upper limit of normal at screening
    • serum unconjugated bilirubin > 3mg/dL at screening
  6. Dialysis or serum creatinine >1.5mg/dL
  7. Hypercholesterolemia: total cholesterol >230 mg/dL or LDL >150 mg/dl or hypertriglyceridemia (triglyceride >200mg/dL) at screening
  8. Laboratory/clinical evidence of: pancreatitis: amylase/lipase >3x upper limit of normal at screening
  9. Known current/active infections including HIV, Hepatitis B, Hepatitis C
  10. History of cancer, excluding skin cancers (squamous cell or basal cell that have been treated)
  11. Known active tuberculosis or untreated tuberculosis
  12. Hemoglobin < 8 g/dL
  13. Expectation by the investigator to increase corticosteroid or immunosuppressive, or immunomodulatory medication dose at screening, baseline, or over the course of the study
  14. Pregnancy or lactation
  15. Consumption of > 2 cups of grapefruit juice per day
  16. Treatment with medications metabolized using the cytochrome P3A4 pathway, such as cyclosporine, tacrolimus, gemfibrozil, niacin, itraconazole, ketoconazole, erythromycin, azithromycin, clarithromycin, bosentan, nefazodone, tricyclic antidepressants
  17. Any condition that, in the opinion of the Investigator, would jeopardize the subject's safety following exposure to the study drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02066311


Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
UCLA David Geffen School of Medicine
Los Angeles, California, United States, 90095
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, New York
Bronx Lebanon Hospital
Bronx, New York, United States, 10457
The Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
New York University School of Medicine
New York, New York, United States, 10016
Columbia University Medical Center
New York, New York, United States, 10032
Hospital for Special Surgery
New York, New York, United States, 20021
Sponsors and Collaborators
Northwell Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Meggan Mackay, MD Northwell Health

Responsible Party: Meggan Mackay, Associate Investigator, MD, Northwell Health
ClinicalTrials.gov Identifier: NCT02066311     History of Changes
Other Study ID Numbers: NISLE
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018

Keywords provided by Meggan Mackay, Northwell Health:
lupus
SLE

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Nelfinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents