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Clinical Trials

MainTitle

Pharmacokinetics of Apricitabine and Tipranavir When Dosed Alone or Together

This study has been completed
Sponsor
Avexa


Information provided by (Responsible Party)
Avexa
ClinicalTrials.gov Identifier
NCT00352066

First received: July 12, 2006
Last updated: June 21, 2011
Last Verified: June 2011
History of Changes
Purpose

Purpose

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 Intervention Phase
HIV Infection

Drug : apricitabine
Phase 1

Study Type: Interventional
Study Design: 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.

Further study details as provided by Avexa:

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. [ Time Frame: 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. [ Time Frame: day 9 and day 10 ]
  • To evaluate the safety and tolerability of apricitabine administered in combination with tipranavir and ritonavir. [ Time Frame: day 10 ]

Enrollment: 18
Study Start Date: July 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 40 Years  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: Yes  

Criteria

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)

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352066

Locations

United States, Michigan
Jasper Clinic Inc
Kalamazoo, Michigan, United States, 49007

Sponsors and Collaborators

Avexa

Investigators

Study Director: Susan W Cox, Ph D Avexa
More Information

More Information


Responsible Party: Susan Cox, Avexa  
ClinicalTrials.gov Identifier: NCT00352066   History of Changes  
Other Study ID Numbers: AVX-102  
Study First Received: July 12, 2006  
Last Updated: June 21, 2011  

Keywords provided by Avexa:

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

Additional relevant MeSH terms:
HIV Infections
Tipranavir

ClinicalTrials.gov processed this data on October 19, 2017
This information is provided by ClinicalTrials.gov.