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Determining the Amount of Time Needed for Nelfinavir to Boost the Immune System in Adults

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00346619
First received: June 28, 2006
Last updated: January 19, 2010
Last verified: January 2010
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigating the Time of Nelfinavir Treatment Necessary for an Increase in Thymic Naive T Cells in Adults.

Resource links provided by NLM:

U.S. FDA Resources

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.

Enrollment: 25
Study Start Date: October 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
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

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00346619     History of Changes
Other Study ID Numbers: 1298-05
Study First Received: June 28, 2006
Last Updated: January 19, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Nelfinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013