Pharmacokinetics of Apricitabine and Tipranavir When Dosed Alone or Together

HIV Infection Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00352066
• Other study ID #: AVX-102
• Status: Completed
• Phase: Phase 1
• First received: July 12, 2006
• Last updated: June 21, 2011
• Start date: July 2006
• Est. completion date: August 2006

Study information

• Verified date: June 2011
• Source: Avexa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV Infection

Intervention

Drug:
• apricitabine

Locations

Country	Name	City	State
United States	Jasper Clinic Inc	Kalamazoo	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Avexa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	To evaluate the safety and tolerability of apricitabine administered in combination with tipranavir and ritonavir.		day 10	Yes