Institutional Review Board, Hospital for Special Surgery
July 23, 2015
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
This study is for patients who have active Systemic Lupus Erythematosus (SLE). 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. Nelfinavir is not approved to treat SLE but it has been used in thousands of patients worldwide for treatment of HIV disease. Thus, its use in this research study for SLE is experimental.
The overall participation will continue over the course of 16 weeks. If a patient meets the study criteria, they will be given the study drug, nelfinavir, to take every day for 8 weeks. There is a final visit 4 weeks after stopping the nelfinavir. There will be 43 total subjects enrolled in this study, but HSS will enroll 4 of these subjects. HSS will enroll subjects through March 31, 2015.
Someone can participate in this study if they:
1. are capable of providing written consent to participate in the study.
2. are at least 18 years old and less than 65 years old.
3. are diagnosed with Systemic Lupus Erythematosus.
4. have elevated levels of anti-double stranded DNA antibodies.
5. are on steroid drugs (the dose must be less than 10 mg daily of prednisone for the last 4 weeks).
6. take certain medication that suppresses their immune system (such as azathioprine, methotrexate. leflunomide, mycophenolate, or hydroxychloroquine) and the dose has been the same for the last 3 months.
7. agree to practice at least 2 approved methods of contraception.
Someone CANNOT participate in this study if they:
1. are taking/have taken rituximab, belimumab, and certain other medications in the last year.
2. have received medication through an IV for the last 3 months.
3. have taken cyclophosphamide within the the last 6 months.
4. their steroid dose increased within the last 4 weeks.
5. have a history of drug or alcohol abuse within the last 6 months.
6. have good liver, pancreas, and kidney function.
7. currently have high cholesterol.
8. have certain infections including HIV, Hepatitis B, Hepatitis .C
9. have had cancer, excluding certain skin cancers.
11. have severe anemia.
12. are pregnant or breastfeeding.
13. consume at least 2 cups of grapefruit juice per day
14. take certain medications that may interfere with the study drug.
Kerri Merritt, Research Coordinator