Pharmacokinetics of Apricitabine and Tipranavir When Dosed Alone or Together

Phase 1

Completed

• Conditions: HIV Infection

• Registration Number: NCT00352066
• Lead Sponsor: Avexa

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.

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 Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-12
• Study First Submitted QC: 2006-07-12
• Study First Posted: 2006-07-14
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-21
• Last Update Posted: 2011-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

• healthy males 18-40 years old
• non-smokers
• no clinically significant medical history

Exclusion Criteria

• current or relevant previous medical history of significance
• hepatitis B, hepatitis C, or HIV positive
• current use of prescription or OTC medications
• use of illicit substances or alcohol (>14 drinks/week)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Jasper Clinic Inc; 🇺🇸 Kalamazoo, Michigan, United States