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This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Combivir in HIV infected, untreated subjects.
A Phase IIb, 96 week, randomized, partially double-blinded, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of GW873140 in combination with Combivir (lamivudine and zidovudine) upon selected immunological and virological markers of HIV-1 infection in antiretroviral therapy naive adults
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW873140 | Drug | |||
| Combivir | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with viral loads <400 copies/mL remaining on randomized treatment through Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| - Comparison of safety and tolerability of different dosage regimens of GW873140 plus Combivir to standard of care regimen. - Assessment of drug resistance over time. - Co-receptor tropism following virological failure. |
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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 | Bakersfield | California | 93301 | United States | ||
| GSK Investigational Site |
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| Beverly Hills |
| California |
| 90210 |
| United States |
| GSK Investigational Site | Los Angeles | California | 90022 | United States |
| GSK Investigational Site | Los Angeles | California | 90095 | United States |
| GSK Investigational Site | San Francisco | California | 94114 | United States |
| GSK Investigational Site | Stanford | California | 94305 | United States |
| GSK Investigational Site | Tarzana | California | 30342 | United States |
| GSK Investigational Site | Denver | Colorado | 80205 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20009 | United States |
| GSK Investigational Site | Miami | Florida | 33136 | United States |
| GSK Investigational Site | Orlando | Florida | 32804 | United States |
| GSK Investigational Site | Tampa | Florida | 33607 | United States |
| GSK Investigational Site | Vero Beach | Florida | 32960 | United States |
| GSK Investigational Site | Conyers | Georgia | 30013 | United States |
| GSK Investigational Site | Chicago | Illinois | 60612 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02114 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55404 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89102 | United States |
| GSK Investigational Site | Newark | New Jersey | 7102 | United States |
| GSK Investigational Site | New York | New York | 10008 | United States |
| GSK Investigational Site | Rochester | New York | 14604 | United States |
| GSK Investigational Site | Portland | Oregon | 97210 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| GSK Investigational Site | Providence | Rhode Island | 02908 | United States |
| GSK Investigational Site | Dallas | Texas | 75208 | United States |
| GSK Investigational Site | Dallas | Texas | 75215 | United States |
| GSK Investigational Site | Dallas | Texas | 75246 | United States |
| GSK Investigational Site | Brussels | 1000 | Belgium |
| GSK Investigational Site | Ottawa | Ontario | K1N 6N5 | Canada |
| GSK Investigational Site | Toronto | Ontario | M4N 3M5 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2L 4P9 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2L 5B1 | Canada |
| GSK Investigational Site | Levallois-Perret | 92300 | France |
| GSK Investigational Site | Lyon | 69288 | France |
| GSK Investigational Site | Nantes | 44093 | France |
| GSK Investigational Site | Paris | 75018 | France |
| GSK Investigational Site | Würzburg | Bavaria | 97080 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60590 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30625 | Germany |
| GSK Investigational Site | Brescia | Lombardy | 25125 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20127 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20157 | Italy |
| GSK Investigational Site | Coimbra | 3000-075 | Portugal |
| GSK Investigational Site | Lisbon | 1169-100 | Portugal |
| GSK Investigational Site | Porto | 4200-319 | Portugal |
| GSK Investigational Site | Madrid | 28029 | 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 | SW10 9TH | 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 |
| C109078 | lamivudine, zidovudine drug combination |
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