Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346619
Status:
COMPLETED
Last Update Posted:
2010-01-20
First Post:
2006-06-28
Brief Title:
Determining the Amount of Time Needed for Nelfinavir to Boost the Immune System in Adults
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Investigating the Time of Nelfinavir Treatment Necessary for an Increase in Thymic Naive T Cells in Adults
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our group has shown that HAART increases the thymic production of naïve T cells in the healthy adult thereby boosting the immune system We propose to investigate the amount of and length of Nelfinavir therapy necessary to increase those cells in adults Subjects will be treated with Nelfinavir and blood will be sampled at variable times to determine the immune response in peripheral blood
Detailed Description:
Blood will be collected at several time points during the study DNA will be isolated from peripheral blood lymphocytes PBL and assessed for signal point sj TREC content relative to genomic CCR5 copies by real time PCR in a spectoflourometic thermal cycler TREC values will be expressed as TREC copy number per copies of CCR5 or TRECPBLs
We anticipate that we will confirm our previous observations that nelfinavir therapy will increase TRECs indicating naive T cell production from the thymus The proposed study will determine the time course of the anticipated increase in TRECPBLs
We anticipate that we will confirm our previous observations that nelfinavir therapy will increase TRECs indicating naive T cell production from the thymus The proposed study will determine the time course of the anticipated increase in TRECPBLs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None