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

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ClinicalTrials.gov Identifier: NCT00385450
Recruitment Status : Terminated (Study closed at Mayo prior to completion)
First Posted : October 9, 2006
Last Update Posted : April 28, 2015
Sponsor:
Information provided by:
Mayo Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Cardiopulmonary Bypass Drug: Nelfinavir/placebo Phase 1

Detailed Description:
See Brief Summary.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor in the Perioperative Period
Study Start Date : October 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nelfinavir/placebo Drug: Nelfinavir/placebo
1250mg/twice each day/four days.




Primary Outcome Measures :
  1. Proportion of Nelfinavir patients v. proportion of placebo patients who have CD4 counts of less than 500 cells/microliter [ Time Frame: Six days. ]

Secondary Outcome Measures :
  1. Changes in quantitative measure of inflammatory markers [ Time Frame: Six days. ]
  2. Changes in clinical outcomes. [ Time Frame: Six days. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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 ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: IRBe Secretary-Ben Wibstad, IRBe
ClinicalTrials.gov Identifier: NCT00385450     History of Changes
Other Study ID Numbers: 05-004052 00
First Posted: October 9, 2006    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2015

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