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This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a day or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed dose combination tablet of abacavir 600 mg and lamivudine 300 mg once a day to suppress virus levels of HIV to less than 400 copies/mL of blood. In addition we will study the safety and tolerability of these compounds over the 48 week study period in patients naive to anti-HIV therapy.
A Phase IIIB, Randomized, Open-Label, Multicenter Study of the Safety and Efficacy of GW433908 (700mg BID) plus ritonavir (100mg BID) Versus Lopinavir/ritonavir (400mg/100mg BID) when Administered in Combination with the Abacavir/Lamivudine (600mg/300mg) Fixed-Dose Combination Tablet QD in Antiretroviral-Naive HIV-1 Infected Adults Over 48 Weeks
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEXIVA (GW433908) | Drug | |||
| Ritonavir | Drug | |||
| KALETRA | Drug | |||
| EPIVIR | Drug | |||
| Ziagen | Drug | |||
| Abacavir/Lamivudine | Drug | |||
| Fosamprenavir | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with plasma HIV-1 RNA <400 copies/mL at Week 48. Proportion of subjects who permanently discontinue randomized treatment due to adverse events. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with plasma HIV-1 RNA <400 copies/mL at Week 48. Proportion of subjects who permanently discontinue randomized treatment due to adverse events. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, Pharm.D. | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35233 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16890834 | Background | Eron J Jr, Yeni P, Gathe J Jr, Estrada V, DeJesus E, Staszewski S, Lackey P, Katlama C, Young B, Yau L, Sutherland-Phillips D, Wannamaker P, Vavro C, Patel L, Yeo J, Shaefer M; KLEAN study team. The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial. Lancet. 2006 Aug 5;368(9534):476-82. doi: 10.1016/S0140-6736(06)69155-1. |
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| Phoenix |
| Arizona |
| 85006 |
| United States |
| GSK Investigational Site | Los Angeles | California | 90046 | United States |
| GSK Investigational Site | Sacramento | California | 95825 | United States |
| GSK Investigational Site | San Francisco | California | 94115-1931 | United States |
| GSK Investigational Site | Denver | Colorado | 80220 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20007 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20036 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20037 | United States |
| GSK Investigational Site | Bradenton | Florida | 34205 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33308 | United States |
| GSK Investigational Site | Miami | Florida | 33136 | United States |
| GSK Investigational Site | Orlando | Florida | 32804 | United States |
| GSK Investigational Site | Pembroke Pines | Florida | 33024 | United States |
| GSK Investigational Site | Tampa | Florida | 33602 | United States |
| GSK Investigational Site | Tampa | Florida | 33607 | United States |
| GSK Investigational Site | Tampa | Florida | 33614 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30308 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30339 | United States |
| GSK Investigational Site | Chicago | Illinois | 60612-7230 | United States |
| GSK Investigational Site | Chicago | Illinois | 60612 | United States |
| GSK Investigational Site | Chicago | Illinois | 60613 | United States |
| GSK Investigational Site | Chicago | Illinois | 60657 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46202 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46280 | United States |
| GSK Investigational Site | Lexington | Kentucky | 40536 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21201 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02115 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02118 | United States |
| GSK Investigational Site | Jackson | Mississippi | 39202 | United States |
| GSK Investigational Site | Hillsborough | New Jersey | 08876 | United States |
| GSK Investigational Site | Newark | New Jersey | 07103 | United States |
| GSK Investigational Site | Somers Point | New Jersey | 08244 | United States |
| GSK Investigational Site | Voorhees Township | New Jersey | 08043 | United States |
| GSK Investigational Site | New York | New York | 10014 | United States |
| GSK Investigational Site | Rochester | New York | 14620 | United States |
| GSK Investigational Site | Stony Brook | New York | 11794-8091 | United States |
| GSK Investigational Site | The Bronx | New York | 10461 | United States |
| GSK Investigational Site | The Bronx | New York | 10468 | United States |
| GSK Investigational Site | Chapel Hill | North Carolina | 27516 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28209 | United States |
| GSK Investigational Site | Durham | North Carolina | 27710 | United States |
| GSK Investigational Site | Greenville | North Carolina | 27858 | United States |
| GSK Investigational Site | Toledo | Ohio | 43614-5809 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19102 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| GSK Investigational Site | Providence | Rhode Island | 02906 | United States |
| GSK Investigational Site | Columbia | South Carolina | 29206-4713 | United States |
| GSK Investigational Site | Knoxville | Tennessee | 37920 | United States |
| GSK Investigational Site | Dallas | Texas | 75208 | United States |
| GSK Investigational Site | Dallas | Texas | 75246 | United States |
| GSK Investigational Site | Fort Worth | Texas | 76104 | United States |
| GSK Investigational Site | Houston | Texas | 77004 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | Charlottesville | Virginia | 22908 | United States |
| GSK Investigational Site | Hampton | Virginia | 23666 | United States |
| GSK Investigational Site | Lynchburg | Virginia | 24501 | United States |
| GSK Investigational Site | Seattle | Washington | 98101 | United States |
| GSK Investigational Site | Seattle | Washington | 98104 | United States |
| GSK Investigational Site | Spokane | Washington | 99204 | United States |
| GSK Investigational Site | Vienna | A-1090 | Austria |
| GSK Investigational Site | Brussels | 1000 | Belgium |
| GSK Investigational Site | Charleroi | 6000 | Belgium |
| GSK Investigational Site | Ghent | 9000 | Belgium |
| GSK Investigational Site | Leuven | 3000 | Belgium |
| GSK Investigational Site | Liège | 4000 | Belgium |
| GSK Investigational Site | Calgary | Alberta | T2P 1H9 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1N 6N5 | Canada |
| GSK Investigational Site | Toronto | Ontario | M4N 3M5 | Canada |
| GSK Investigational Site | Toronto | Ontario | M4T 3A7 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5B 1W8 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5G 2C4 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2L 4P9 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2L 5B1 | Canada |
| GSK Investigational Site | Bordeaux | 33076 | France |
| GSK Investigational Site | Le Kremlin-Bicêtre | 94275 | France |
| GSK Investigational Site | Lyon | 69288 | France |
| GSK Investigational Site | Lyon | 69437 | France |
| GSK Investigational Site | Paris | 75018 | France |
| GSK Investigational Site | Paris | 75475 | France |
| GSK Investigational Site | Paris | 75651 | France |
| GSK Investigational Site | Paris | 75679 | France |
| GSK Investigational Site | Saint-Denis | 93205 | France |
| GSK Investigational Site | Fürth | Bavaria | 90762 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80331 | Germany |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 20099 | Germany |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 20146 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60590 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30159 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13353 | Germany |
| GSK Investigational Site | Ferrara | Emilia-Romagna | 44100 | Italy |
| GSK Investigational Site | Modena | Emilia-Romagna | 41100 | Italy |
| GSK Investigational Site | Rimini | Emilia-Romagna | 47900 | Italy |
| GSK Investigational Site | Busto Arsizio (VA) | Lombardy | 21052 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20127 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20157 | Italy |
| GSK Investigational Site | Turin | Piedmont | 10149 | Italy |
| GSK Investigational Site | Riga | LV 1006 | Latvia |
| GSK Investigational Site | Luxembourg | 1210 | Luxembourg |
| GSK Investigational Site | Bydgoszcz | 85-030 | Poland |
| GSK Investigational Site | Szczecin | 71-455 | Poland |
| GSK Investigational Site | Wroclaw | 51-149 | Poland |
| GSK Investigational Site | Cascais | 2750 | Portugal |
| GSK Investigational Site | Bucharest | 030303 | Romania |
| GSK Investigational Site | Iași | 700116 | Romania |
| GSK Investigational Site | Barcelona | 08003 | Spain |
| GSK Investigational Site | Elche (Alicante) | 03202 | Spain |
| GSK Investigational Site | Madrid | 28034 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Madrid | 28047 | Spain |
| GSK Investigational Site | Málaga | 29010 | Spain |
| GSK Investigational Site | Palma de Mallorca | 07014 | Spain |
| GSK Investigational Site | Seville | 41013 | Spain |
| GSK Investigational Site | Tarrasa, Barcelona | 08221 | Spain |
| GSK Investigational Site | Valencia | 46010 | Spain |
| GSK Investigational Site | Vigo ( Pontevedra) | 36204 | Spain |
| GSK Investigational Site | Lugano | 6900 | Switzerland |
| GSK Investigational Site | Olten | 4600 | Switzerland |
| GSK Investigational Site | Sankt Gallen | 9007 | Switzerland |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D007239 | Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| 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 |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| C426859 | fosamprenavir |
| D019438 | Ritonavir |
| C558899 | lopinavir-ritonavir drug combination |
| D019259 | Lamivudine |
| C106538 | abacavir |
| C492871 | abacavir, lamivudine drug combination |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
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