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To determine the effect of BILR 355/r on tipranavir/r pharmacokinetics and the effect of tipranavir/r on BILR 355 BS pharmacokinetics
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tipranavir and high dose of ritonavir plus BILR 355 BS | Experimental |
| |
| BILR 355 BS with low dose of ritonavir | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BILR 355 BS | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of tipranavir and BILR 355 BS in plasma over one dosing interval (12 hours) at steady state (AUC0-12h,ss) | up to 18 days after start of treatment | |
| Maximum measured concentration of tipranavir and BILR 355 BS in plasma at steady state over a dosing interval τ (Cmax,ss) | up to 18 days after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Apparent clearance of BILR 355 BS, tipranavir and ritonavir in plasma following extravascular administration at steady state (CL/F,ss) | up to 18 days after start of treatment | |
| Time from dosing to the maximum concentration of BILR 355 BS, tipranavir and ritonavir in plasma at steady state (tmax,ss) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C107201 | tipranavir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Tipranavir |
| Drug |
|
| Low dose of ritonavir | Drug |
|
| High dose of ritonavir | Drug |
|
| up to 18 days after start of treatment |
| Terminal half-life of BILR 355 BS, tipranavir and ritonavir in plasma at steady state (t1/2,ss) | up to 18 days after start of treatment |
| Apparent volume of distribution of BILR 355 BS, tipranavir and ritonavir during the terminal phase λz at steady state following an extravascular dose (Vz/F,ss) | up to 18 days after start of treatment |
| Area under the concentration-time curve of ritonavir in plasma over one dosing interval (12 hours), (AUC0-12h) | up to 18 days after start of treatment |
| Maximum measured concentration of ritonavir in plasma at steady state over a dosing interval τ (Cmax,ss) | up to 18 days after start of treatment |
| Measured concentration of BILR 355 BS, tipranavir and ritonavir in plasma 12 hours post last dose at steady state (Cp12h,ss) | up to 18 days after start of treatment |
| Number of participants with clinically relevant changes in laboratory parameters | up to 28 days after start of treatment |
| Number of participants with clinically relevant changes in vital signs (blood pressure, pulse rate) | up to 28 days after start of treatment |
| Number of participants with clinically relevant changes in 12-lead ECG | up to 14 days after start of treatment |
| Number of participants with adverse events | Up to 7 weeks |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |