NCT00346619

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

January 20, 2010

Status Verified

January 1, 2010

Enrollment Period

2 years

First QC Date

June 28, 2006

Last Update Submit

January 19, 2010

Conditions

Immune Response

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

NelfinavirDRUG

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Rizza SR, Tangalos EG, McClees MD, Strausbauch MA, Targonski PV, McKean DJ, Wettstein PJ, Badley AD. Nelfinavir monotherapy increases naive T-cell numbers in HIV-negative healthy young adults. Front Biosci. 2008 Jan 1;13:1605-9. doi: 10.2741/2784.

    PMID: 17981652DERIVED

MeSH Terms

Interventions

Nelfinavir

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Stacey R. Vlahakis, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 28, 2006

First Posted

June 30, 2006

Study Start

October 1, 2005

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

January 20, 2010

Record last verified: 2010-01

Locations

US(1)