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Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor

This study has been terminated.
(Study closed at Mayo prior to completion)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00385450
First received: October 5, 2006
Last updated: December 3, 2009
Last verified: December 2009
History of Changes
  Purpose

In previous studies, 90% of patients who underwent elective cardiopulmonary bypass procedure manifested CD4 counts of less than 500 cells/microliter in the immediate (day 1) post-operative period. This study will investigate whether or not Nelfinavir increases those CD4 counts in the post-operative period.


Condition Intervention Phase
Cardiopulmonary Bypass
 Drug: Nelfinavir/placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor in the Perioperative Period

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Proportion of Nelfinavir patients v. proportion of placebo patients who have CD4 counts of less than 500 cells/microliter [ Time Frame: Six days. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in quantitative measure of inflammatory markers [ Time Frame: Six days. ] [ Designated as safety issue: No ]
  • Changes in clinical outcomes. [ Time Frame: Six days. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 64
Study Start Date: October 2006
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Nelfinavir/placebo
    1250mg/twice each day/four days.
Detailed Description:

See Brief Summary.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any patient undergoing elective (non-emergency) cardiopulmonary bypass for coronary artery bypass grafting, cardiac valve replacement, or both.

Exclusion Criteria:

  • A dozen different medical conditions and two dozen medical contraindications.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00385450

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

Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: IRBe Secretary-Ben Wibstad, IRBe
ClinicalTrials.gov Identifier: NCT00385450     History of Changes
Other Study ID Numbers: 05-004052 00
Study First Received: October 5, 2006
Last Updated: December 3, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphopenia
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Protease Inhibitors
Nelfinavir
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
HIV Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013