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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00385450

Enrollment

Registered

2006-10-09

Start date

2006-10-31

Completion date

2008-10-31

Last updated

2015-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopulmonary Bypass

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.

Interventions

DRUGNelfinavir/placebo

1250mg/twice each day/four days.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Changes in quantitative measure of inflammatory markers	Six days.
Changes in clinical outcomes.	Six days.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026