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The Effects of HIV Protease Inhibitors in Severe Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00346580
Recruitment Status : Completed
First Posted : June 30, 2006
Last Update Posted : April 5, 2011
Information provided by:
Mayo Clinic

Brief Summary:
Sepsis is the leading cause of death in critically ill patients in the United States. It develops in approximately 750,000 Americans annually, and more than 210,000 of them die. Despite improvements in supportive treatment, mortality has changed very little, and until recently, no sepsis-specific treatments were available. Protease inhibitors have seemed to have an immune benefit that extends beyond their ability to prevent HIV replication. T cells in those patients treated with protease inhibitors have reduced rates of death than in those patients not receiving therapy.

Condition or disease Intervention/treatment Phase
Sepsis Drug: Nelfinavir Phase 1

Detailed Description:
Our hypothesis is that protease inhibitor therapy will prevent apoptosis associated with sepsis, and this will be manifested as improved clinical outcome, as assessed by 28-day mortality, APACHE II and III, and SOFA scores. All patients enrolled in the study will receive the standard of care for sepsis at Mayo Clinic Rochester. Patients will receive 1250 mg of Nelfinavir/placebo twice each day for seven days with regularly scheduled blood draws (Days 0, 4, and 7).

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effects of HIV Protease Inhibitors in Severe Sepsis
Study Start Date : June 2003
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Sepsis

Primary Outcome Measures :
  1. Death from any cause at 28 days and 3 months
  2. Daily APACHE II and III scores
  3. Daily SOFA scores

Secondary Outcome Measures :
  1. Change in CD4 and CD8 T-cell apoptosis, as determined by flow cytomerty, at the time of enrollment, on Day 4 of therapy, and upon completion of therapy.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Infection criteria:known or suspected infection, as evidenced by one or more of the following: WBC in normally sterile body fluid, radiographic evidence of pneumonia, a syndrome associated with a high risk of infection.

Modified SIRS criteria: must meet three or more of the following four criteria: a temperature higher than 38C or lower than 36C, heart rate of more than 90 beats/minute, respiratory rate of more than 20 breaths/minute (or on a mechanical ventilator), WBC more than 12,000/mm(3) or less than 4,000/mm(3).

Dysfunctional organs criteria:must meet one or more of the following five criteria:cardiovascular system dysfunction, kidney dysfunction, respiratory dysfunction, hematological dysfunction, unexplained metabolic acidosis.

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 identifier (NCT number): NCT00346580

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Andrew D. Badley, M.D. Mayo Clinic
Layout table for additonal information Identifier: NCT00346580    
Other Study ID Numbers: 1254-03
First Posted: June 30, 2006    Key Record Dates
Last Update Posted: April 5, 2011
Last Verified: April 2011
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Pathologic Processes
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents