Pharmacokinetics of Apricitabine and Tipranavir When Dosed Alone or Together

Avexa

Status and phase: Completed; Phase 1

Conditions: HIV Infection

Treatments: Drug: apricitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00352066

AVX-102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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)