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Nelfinavir in Systemic Lupus Erythematosus: A Pilot Phase IIa Clinical Trial
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Cedars-Sinai Medical Center
Los Angeles, California, United States
UCLA David Geffen School of Medicine
Los Angeles, California, United States
Rush University Medical Center
Chicago, Illinois, United States
The Feinstein Institute for Medical Research
Manhasset, New York, United States
New York University School of Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Hospital for Special Surgery
New York, New York, United States
Bronx Lebanon Hospital
The Bronx, New York, United States
Start Date
September 1, 2014
Primary Completion Date
June 1, 2018
Completion Date
June 1, 2018
Last Updated
February 24, 2020
15
ACTUAL participants
Nelfinavir
DRUG
Lead Sponsor
Northwell Health
Collaborators
NCT06647069
NCT07371468
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06333483