The Effects of HIV Protease Inhibitors in Severe Sepsis - Full Text View

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00346580

Purpose

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	Intervention	Phase
Sepsis	Drug: Nelfinavir	Phase I

MedlinePlus related topics: AIDS Sepsis

Drug Information available for: Nelfinavir Nelfinavir Mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study
Official Title:	The Effects of HIV Protease Inhibitors in Severe Sepsis

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Death from any cause at 28 days and 3 months
Daily APACHE II and III scores
Daily SOFA scores

Secondary Outcome Measures:

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.

Estimated Enrollment:	60
Study Start Date:	June 2003
Estimated Study Completion Date:	September 2005

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346580

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Andrew D. Badley, M.D.

Mayo Clinic

More Information

Study ID Numbers:	1254-03
Study First Received:	June 28, 2006
Last Updated:	June 28, 2006
ClinicalTrials.gov Identifier:	NCT00346580
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Sepsis
HIV Infections

Acquired Immunodeficiency Syndrome
Nelfinavir
Inflammation

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
Anti-HIV Agents
Pathologic Processes
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009