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

Investigating the Time of Nelfinavir Treatment Necessary for an Increase in Thymic Naive T Cells in Adults.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00346619

Enrollment

Registered

2006-06-30

Start date

2005-10-31

Completion date

2007-10-31

Last updated

2010-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Response

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 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.

Interventions

DRUGNelfinavir

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026