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Study to determine the pharmacokinetic effect of BILR 355 + ritonavir® on TRUVADA and TRUVADA on BILR 355
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRUVADA with BILR 355 BS and ritonavir | Experimental |
| |
| BILR 355 BS in combination with ritonavir | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BILR 355 BS | Drug |
| ||
| Ritonavir |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from 0 to 24 hours at steady state of the analyte in plasma (AUC0-24h,ss) | up to 24 h after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Apparent clearance of the analyte in plasma following extravascular administration at steady state (CL/F,ss) | up to day 18 after start of treatment | |
| Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss) | up to day 18 after start of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D019438 | Ritonavir |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Drug |
|
| TRUVADA | Drug |
|
| Measured concentration of the analyte in plasma 24 hours post last dose at steady state (Cp24h, ss) | up to 24 h after treatment |
| Terminal half-life of of the analyte in plasma in the plasma at steady state (t1/2, ss) | up to day 18 after start of treatment |
| Apparent volume of distribution of of the analyte in plasma during the terminal phase λz at steady state following an extravascular dose (Vz/F,ss) | up to day 18 after start of treatment |
| Area under the concentration-time curve from 0 to 24 hours of ritonavir in plasma (AUC0-24h) | up to 24 h after treatment |
| Maximum measured concentration of ritonavir in plasma (Cmax) | up to 24 h after treatment |
| Number of subjects with clinically relevant changes in clinical laboratory tests | up to day 28 after start of treatment |
| Number of subjects with clinically relevant changes in vital signs (blood pressure, pulse rate) | up to day 28 after start of treatment |
| Number of subjects with adverse events | Up to 7 weeks |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |