Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor
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.
|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|
- 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 ]
- 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 ]
|Study Start Date:||October 2006|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
1250mg/twice each day/four days.
See Brief Summary.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00385450
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Andrew D. Badley, M.D.||Mayo Clinic|