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OpenTrials
Completed

NCT Number: NCT00352066

Pharmacokinetics of Apricitabine and Tipranavir When Dosed Alone or Together

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.

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Key information

Conditions

HIV Infection Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Jasper Clinic Inc

Kalamazoo, Michigan, 49007, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

apricitabine

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Avexa

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jul 14, 2006
Registry last updated
Jun 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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