Determining the Amount of Time Needed for Nelfinavir to Boost the Immune System in Adults
- Conditions
- Immune Response
- Registration Number
- NCT00346619
- Lead Sponsor
- Mayo Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States