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

Phase 1

Terminated

• Conditions: Cardiopulmonary Bypass
• Interventions: Drug: Nelfinavir/placebo

• Registration Number: NCT00385450
• Lead Sponsor: 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.

Detailed Description

See Brief Summary.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-05
• Study First Submitted QC: 2006-10-06
• Study First Posted: 2006-10-09
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-27
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nelfinavir/placebo	Nelfinavir/placebo	-

Primary Outcome Measures

Name	Time	Method
Proportion of Nelfinavir patients v. proportion of placebo patients who have CD4 counts of less than 500 cells/microliter	Six days.

Secondary Outcome Measures

Name	Time	Method
Changes in quantitative measure of inflammatory markers	Six days.
Changes in clinical outcomes.	Six days.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States