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For HIV-infected individuals with highly resistant viruses, higher drug levels may be required to block the virus. This study investigates that concept by comparing the efficacy of standard fosamprenavir/ritonavir to an increased dose of boosted fosamprenavir and to a combination of fosamprenavir (increased dose)/lopinavir/ritonavir.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fosamprenavir/ritonavir (700mg/100mg BID) | Drug | |||
| fosamprenavir/ritonavir (1400mg/100mg BID) | Drug | |||
| fosamprenavir/lopinavir/ritonavir (1400mg/533mg/100mg BID) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The average area under the curve minus baseline [AAUCMB] in plasma HIV-1 RNA at 24 Weeks when each are administered in combination with an optimised background therapy, in a multiple PI-experienced population experiencing virological failure. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy (AAUCMB) at 48 weeks, safety, tolerability(incidence and nature of AEs and laboratory abnormalities) at week 24 and 48, CD4 change from baseline at week 24 and 48, and the steady-state plasma APV and LPV through concentrations. | 48 weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, MD | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Clinical Trials Call Center | Darlinghurst | New South Wales | 2010 | Australia | ||
| GSK Clinical Trials Call Center |
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| Carlton |
| Victoria |
| 3053 |
| Australia |
| GSK Clinical Trials Call Center | Brussels | 1000 | Belgium |
| GSK Clinical Trials Call Center | Vancouver | British Columbia | V6Z 2C7 | Canada |
| GSK Clinical Trials Call Center | Hamilton | Ontario | L8N 3Z5 | Canada |
| GSK Clinical Trials Call Center | Ottawa | Ontario | K1N 6N5 | Canada |
| GSK Clinical Trials Call Center | Toronto | Ontario | M4T 3A7 | Canada |
| GSK Clinical Trials Call Center | Toronto | Ontario | M5B 1L6 | Canada |
| GSK Clinical Trials Call Center | Montreal | Quebec | H2L 5B1 | Canada |
| GSK Clinical Trials Call Center | Montreal | Quebec | H3G 1A4 | Canada |
| GSK Clinical Trials Call Center | Saint-Foy | Quebec | G1V 4G2 | Canada |
| GSK Clinical Trials Call Center | Lagny-sur-Marne | 77400 | France |
| GSK Clinical Trials Call Center | Paris | 75475 | France |
| GSK Clinical Trials Call Center | Paris | 75970 | France |
| GSK Clinical Trials Call Centre | Paris | 93009 | France |
| GSK Clinical Trials Call Center | Saint-Denis | 93205 | France |
| GSK Clinical Trials Call Center | Strasbourg | 67000 | France |
| GSK Clinical Trials Call Center | Toulon | 83000 | France |
| GSK Clinical Trials Call Center | Vanouvre Les Nancy | 54511 | France |
| GSK Clinical Trials Call Center | Hamburg | 20095 | Germany |
| GSK Clinical Trials Call Center | Athens | 10676 | Greece |
| GSK Clinical Trials Call Center | Athens | 11526 | Greece |
| GSK Clinical Trials Call Center | Athens | 11527 | Greece |
| GSK Clinical Trials Call Center | Piraeus | 18536 | Greece |
| GSK Clinical Trials Call Center | Liguria | 16128 | Italy |
| GSK Clinical Trials Call Center | Lombardia | 27100 | Italy |
| GSK Clinical Trials Call Center | Romagna | 44100 | Italy |
| GSK Clinical Trials Call Center | Rome | 00 168 | Italy |
| GSK Clinical Trials Call Centre | Torino | 10149 | Italy |
| GSK Clinical Trials Call Center | Toscana | 50126 | Italy |
| GSK Clinical Trials Call Center | Toscana | 50139 | Italy |
| GSK Clinical Trials Call Center | Veneto | 35128 | Italy |
| GSK Clinical Trials Call Center | Barcelona | 8025 | Spain |
| GSK Clinical Trials Call Center | Jerez de la Frontera | 11407 | Spain |
| GSK Clinical Trials Call Center | Madrid | 28029 | Spain |
| GSK Clinical Trials Call Center | Madrid | 28040 | Spain |
| GSK Clinical Trials Call Center | Madrid | 28041 | Spain |
| GSK Clinical Trials call Center | Birmingham | B29 JD6 | United Kingdom |
| GSK Clinical Trials Call Center | Brighton | BN2 3EW | United Kingdom |
| GSK Clinical Trials Call Center | London | EC1A 7BE | United Kingdom |
| GSK Clinical Trials Call Center | London | NW3 2QG | United Kingdom |
| GSK Clinical Trials Call Center | London | SE5 9RS | United Kingdom |
| ID | Term |
|---|---|
| C426859 | fosamprenavir |
| D019438 | Ritonavir |
| C494814 | BID protein, human |
| D061466 | Lopinavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
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