Determining the Amount of Time Needed for Nelfinavir to Boost the Immune System in Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00346619|
Recruitment Status : Completed
First Posted : June 30, 2006
Last Update Posted : January 20, 2010
|Condition or disease||Intervention/treatment||Phase|
|Immune Response||Drug: Nelfinavir||Phase 1|
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 TREC/PBLs.
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 TREC/PBLs.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigating the Time of Nelfinavir Treatment Necessary for an Increase in Thymic Naive T Cells in Adults.|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
- Will confirm that HIV protease inhibitors increase thymic naïve T-cell production and determine the dose and time needed to increase thymic T-cell production in adults.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346619
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Stacey R. Vlahakis, M.D.||Mayo Clinic|