Nelfinavir in Systemic Lupus Erythematosus

ClinicalTrials.gov ID: NCT02066311

Public ClinicalTrials.gov record NCT02066311. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

Nelfinavir in Systemic Lupus Erythematosus: A Pilot Phase IIa Clinical Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT02066311
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 2
Lead sponsor: Northwell Health; Other
Enrollment: 15 participants

Conditions and interventions

Conditions

Systemic Lupus Erythematosus

Interventions

Nelfinavir Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 31, 2014
Primary completion: May 31, 2018
Completion: May 31, 2018
Last update posted: Feb 23, 2020

2014 – 2018

United States locations

U.S. sites: 8
U.S. states: 3
U.S. cities: 5

Facility	City	State	ZIP	Site status
Cedars-Sinai Medical Center	Los Angeles	California	90048	—
UCLA David Geffen School of Medicine	Los Angeles	California	90095	—
Rush University Medical Center	Chicago	Illinois	60612	—
The Feinstein Institute for Medical Research	Manhasset	New York	11030	—
New York University School of Medicine	New York	New York	10016	—
Columbia University Medical Center	New York	New York	10032	—
Hospital for Special Surgery	New York	New York	20021	—
Bronx Lebanon Hospital	The Bronx	New York	10457	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02066311, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Feb 23, 2020 · Synced Sep 11, 2026

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