A Phase 1 interventional study of apricitabine in HIV Infection, sponsored by Avexa. Completed at 1 site in United States. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-23.
Sponsored by Avexa · Phase 1 and Interventional
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.
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 18 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Avexa is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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Avexa