The Effects of HIV Protease Inhibitors in Severe Sepsis

NCT00346580 | Completed Phase 1

• 1 other identifier: 1254-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (3)

• Death from any cause at 28 days and 3 months

• Daily APACHE II and III scores

• Daily SOFA scores

Secondary Outcomes (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.

Interventions

Nelfinavir DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Sepsis

Interventions

Nelfinavir

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Andrew D. Badley, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 28, 2006
• First Posted: June 30, 2006
• Study Start: June 1, 2003
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: April 5, 2011

Record last verified: 2011-04

Locations

US (1)