Pharmacokinetics of Apricitabine and Tipranavir When Dosed Alone or Together

Sponsor

Avexa (Industry)

Overall Status

Completed

CT.gov ID

NCT00352066

Collaborator

(none)

Enrollment

Location

Duration (Months)

17.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to see if apricitabine or tipranavir affect the levels of each other in the blood (pharmacokinetic interaction) when they are dosed together.

Condition or Disease	Intervention/Treatment	Phase
HIV Infection	Drug: apricitabine	Phase 1

Detailed Description

Apricitabine is a new NRTI in development for treatment of drug resistant HIV. Tipranavir is a recently licensed protease inhibitor for treatment of drug resistant HIV. Tipranavir affects the plasma concentration of some other drugs when they are used together with tipranavir. This study will examine whether the pharmacokinetics of apricitabine are changed when it is dosed together with tipranavir compared to apricitabine alone. Also, the pharmacokinetics of tipranavir will be examined at steady state when it is dosed alone and when it is dosed together with apricitabine. Information on the safety and tolerability of the two drugs when dosed together will also be obtained.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

A Phase I, Open Label, Controlled, Intra-subject Comparison Study to Investigate the Effect of Co-administration Upon the Pharmacokinetics of Tipranavir (Ritonavir Boosted) and Apricitabine.

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Aug 1, 2006

Actual Study Completion Date :

Aug 1, 2006

Outcome Measures

Primary Outcome Measures

To compare the single dose pharmacokinetics of apricitabine when administered alone and in the presence of steady state concentrations of tipranavir 500 mg administered twice daily in combination with ritonavir 200 mg twice daily. [day 1 and day 10]

Secondary Outcome Measures

To compare the steady state pharmacokinetics of tipranavir 500 mg administered twice daily with ritonavir 200mg in the presence and absence of apricitabine. [day 9 and day 10]
To evaluate the safety and tolerability of apricitabine administered in combination with tipranavir and ritonavir. [day 10]