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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 30, 2014