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Pharmacokinetics of Apricitabine and Tipranavir When Dosed Alone or Together

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ClinicalTrials.gov Identifier: NCT00352066
Recruitment Status : Completed
First Posted : July 14, 2006
Last Update Posted : June 23, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: apricitabine Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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.
Study Start Date : July 2006
Primary Completion Date : August 2006
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Tipranavir
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. To evaluate the safety and tolerability of apricitabine administered in combination with tipranavir and ritonavir. [ Time Frame: day 10 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Susan Cox, Avexa
ClinicalTrials.gov Identifier: NCT00352066     History of Changes
Other Study ID Numbers: AVX-102
First Posted: July 14, 2006    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tipranavir
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents