Determining the Amount of Time Needed for Nelfinavir to Boost the Immune System in Adults - Full Text View

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00346619

Purpose

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.

Condition	Intervention	Phase
Immune Response	Drug: Nelfinavir	Phase I

Drug Information available for: Nelfinavir Nelfinavir Mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Investigating the Time of Nelfinavir Treatment Necessary for an Increase in Thymic Naive T Cells in Adults.

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

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.

Estimated Enrollment:	25
Study Start Date:	October 2005

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 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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Healthy individuals between the ages of 20 and 100. Exclusion criteria include the following: HIV, HBV/HCV positive, known sensitivity to protease inhibitors, oral intake contraindicated, diabetes mellitus diagnosed within the last six months, and any of the following medications: cisapride, amiodarone, terfenadine, rifampin/rifabutin, phenobarbital, pinozide, St. John's wort, ergot derivatives, quinidine, astemazole, carbemazapine, phenytoin, midazolam, triazolam, and simvastatin.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346619

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Stacey R. Vlahakis, M.D.

Mayo Clinic

More Information

Publications indexed to this study:

Rizza SR, Tangalos EG, McClees MD, Strausbauch MA, Targonski PV, McKean DJ, Wettstein PJ, Badley AD. Nelfinavir monotherapy increases naïve T-cell numbers in HIV-negative healthy young adults. Front Biosci. 2008 Jan 1;13:1605-9.

Study ID Numbers:	1298-05
Study First Received:	June 28, 2006
Last Updated:	December 22, 2007
ClinicalTrials.gov Identifier:	NCT00346619
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Nelfinavir

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Enzyme Inhibitors
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009