Pharmacokinetics of Apricitabine and Tipranavir When Dosed Alone or Together

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00352066

Enrollment

Registered

2006-07-14

Start date

2006-07-31

Completion date

2006-08-31

Last updated

2011-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

Human Immunodeficiency Virus, anti-retroviral therapy, nucleoside analogue, reverse transcriptase, apricitabine, tipranavir, bioequivalence, drug-drug interaction, pharmacokinetics

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.

Interventions

DRUGapricitabine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026