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This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Kaletra in HIV infected, untreated subjects.
A Phase IIb, 96 week, randomized, open-label, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of different doses and regimens of GW873140 in combination with Kaletra (lopinavir and ritonavir) in HIV-1 infected antiretroviral therapy naive subjects
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW873140 | Drug | |||
| Kaletra (lopinavir/ritonavir) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To select a GW873140 dose and dosage regimen for further evaluation based on comparison of the short-term antiviral activity, safety and tolerability of different oral doses of GW873140 in combination with LPV/r in HIV-1 infected therapy-naive subjects. |
| Measure | Description | Time Frame |
|---|---|---|
| HIV-1 RNA decay rate Long-term safety Effects on plasma viral tropismViral resistance to GW873140 and other on-study drugsPK parameters of GW873140 in subjects receiving combination therapy. |
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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 Investigational Site | Phoenix | Arizona | 85006 | United States | ||
| GSK Investigational Site |
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| Tucson |
| Arizona |
| 85745 |
| United States |
| GSK Investigational Site | Fountain Valley | California | 92708 | United States |
| GSK Investigational Site | Long Beach | California | 90813 | United States |
| GSK Investigational Site | Los Angeles | California | 90027 | United States |
| GSK Investigational Site | Los Angeles | California | 90069 | 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 | Bradenton | Florida | 34205 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33306 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33308 | United States |
| GSK Investigational Site | Fort Myers | Florida | 33901 | United States |
| GSK Investigational Site | Orlando | Florida | 32804 | United States |
| GSK Investigational Site | Tampa | Florida | 33614 | United States |
| GSK Investigational Site | West Palm Beach | Florida | 33408 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30308 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30339 | United States |
| GSK Investigational Site | Chicago | Illinois | 60613 | United States |
| GSK Investigational Site | Chicago | Illinois | 60657 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70115 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70127-0800 | United States |
| GSK Investigational Site | Jackson | Mississippi | 39202 | United States |
| GSK Investigational Site | Santa Fe | New Mexico | 87505 | United States |
| GSK Investigational Site | New York | New York | 10014 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28209 | United States |
| GSK Investigational Site | Portland | Oregon | 97209 | United States |
| GSK Investigational Site | Allentown | Pennsylvania | 18103 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19102 | United States |
| GSK Investigational Site | Houston | Texas | 77027 | United States |
| GSK Investigational Site | Hampton | Virginia | 23666 | United States |
| GSK Investigational Site | Vancouver | British Columbia | V6Z 2C7 | Canada |
| GSK Investigational Site | Hamilton | Ontario | L8N 3Z5 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1H 8L6 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5G 2N2 | Canada |
| GSK Investigational Site | Sainte-Foy | Quebec | G1V 4G2 | Canada |
| GSK Investigational Site | Copenhagen | DK-2100 | Denmark |
| GSK Investigational Site | Hvidovre | DK-2650 | Denmark |
| GSK Investigational Site | Le Kremlin-BicĂȘtre | 94275 | France |
| GSK Investigational Site | Marseille | 13005 | France |
| GSK Investigational Site | Nantes | 44093 | France |
| GSK Investigational Site | Paris | 75018 | France |
| GSK Investigational Site | Paris | 75475 | France |
| GSK Investigational Site | Paris | 75571 | France |
| GSK Investigational Site | Paris | 75651 | France |
| GSK Investigational Site | Paris | 75679 | France |
| GSK Investigational Site | Paris | 75970 | France |
| GSK Investigational Site | Saint-Denis | 93205 | France |
| GSK Investigational Site | Tourcoing | 59208 | France |
| GSK Investigational Site | Villejuif | 94804 | France |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60590 | Germany |
| GSK Investigational Site | Bonn | North Rhine-Westphalia | 53127 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 50937 | Germany |
| GSK Investigational Site | Berlin | 13353 | Germany |
| GSK Investigational Site | Hamburg | 20099 | Germany |
| GSK Investigational Site | Hamburg | 20146 | Germany |
| GSK Investigational Site | Milan | Lombardy | 20127 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20157 | Italy |
| GSK Investigational Site | Turin | Piedmont | 10149 | Italy |
| GSK Investigational Site | Amsterdam | 1066 EC | Netherlands |
| GSK Investigational Site | Cascais | 2750 | Portugal |
| GSK Investigational Site | Lisbon | 1150 | Portugal |
| GSK Investigational Site | Madrid | 28034 | Spain |
| GSK Investigational Site | Seville | 41013 | Spain |
| GSK Investigational Site | Manchester | Lancashire | M8 5RB | United Kingdom |
| GSK Investigational Site | Brighton | Sussex East | BN2 1ES | United Kingdom |
| GSK Investigational Site | Birmingham | Warwickshire | B29 6JD | United Kingdom |
| GSK Investigational Site | London | EC1 7BE | United Kingdom |
| GSK Investigational Site | London | NW3 2QG | United Kingdom |
| ID | Term |
|---|---|
| D007239 | Infections |
| D015658 | HIV Infections |
| 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 |
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| ID | Term |
|---|---|
| C499671 | aplaviroc |
| C558899 | lopinavir-ritonavir drug combination |
| D061466 | Lopinavir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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