NCT00385450

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

2 years

First QC Date

October 5, 2006

Last Update Submit

April 27, 2015

Conditions

Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

  • Proportion of Nelfinavir patients v. proportion of placebo patients who have CD4 counts of less than 500 cells/microliter

    Six days.

Secondary Outcomes (2)

  • Changes in quantitative measure of inflammatory markers

    Six days.

  • Changes in clinical outcomes.

    Six days.

Study Arms (1)

Nelfinavir/placebo

EXPERIMENTAL
Drug: Nelfinavir/placebo

Interventions

Nelfinavir/placeboDRUG

1250mg/twice each day/four days.

Nelfinavir/placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient undergoing elective (non-emergency) cardiopulmonary bypass for coronary artery bypass grafting, cardiac valve replacement, or both.

You may not qualify if:

  • A dozen different medical conditions and two dozen medical contraindications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Nelfinavir

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Andrew D. Badley, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 5, 2006

First Posted

October 9, 2006

Study Start

October 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

US(1)