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

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00385450

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 I

Drug Information available for: Nelfinavir Nelfinavir Mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor in the Perioperative Period

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:

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	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mark D McClees 507-538-2857 mcclees.mark@mayo.edu
Principal Investigator: Andrew D Badley, M.D.

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Andrew D. Badley, M.D.

Mayo Clinic

More Information

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

Responsible Party:	IRBe ( IRBe Secretary-Ben Wibstad )
Study ID Numbers:	05-004052 00
Study First Received:	October 5, 2006
Last Updated:	December 24, 2007
ClinicalTrials.gov Identifier:	NCT00385450
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hematologic Diseases
Lymphopenia
Leukocyte Disorders

Nelfinavir
Leukopenia
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009