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To determine the effect of steady-state tipranavir 500 mg/ritonavir 200 mg (TPV/r) on intracellular concentrations of zidovudine triphosphate (ZDV-TP) and carbovir triphosphate (CBV-TP) and plasma viral load
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPV/r (Tipranavir co-administered with low dose ritonavir) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tipranavir capsules | Drug |
| ||
| Ritonavir capsules |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-12h (Area under curve) of intracellular ZDV-TP | Up to 12 hours after drug administration | |
| AUC0-12h (Area under curve) of carbovir-TP | Up to 12 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with clinical significant findings in vital sings | Up to 14 days after last drug administration | |
| Number of patients with clinical significant findings in physical examinations | Up to 14 days after last drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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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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| Drug |
|
| Number of patients with clinical significant findings in laboratory measurements | Up to 14 days after last drug administration |
| Concentration of Zidovudine (ZDV) in plasma | Up to 14 days after drug administration |
| Concentration of Abacavir (ABC) in plasma | Up to 14 days after drug administration |
| Concentration of Tipranavir (TPV) in plasma | Up to 14 days after drug administration |
| Concentration of ritonavir in plasma | Up to 14 days after drug administration |
| Cmax (Maximum observed concentration) | Up to 14 days after drug administration |
| Cp12h (Trough plasma concentration) | Up to 14 days after drug administration |
| AUC0-12h (Area under curve) | Up to 14 days after drug administration |
| Number of patients with adverse events | Up to 14 days after last drug adminnistration |
| Percentage of patients with viral load (VL) <50 | Up to 14 days after last drug adminnistration |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |