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The aim of this study was to assess whether TRIZIVIR, administered twice-daily was as safe, tolerable and efficacious as a combination of the drugs COMBIVIR administered twice-daily and atazanavir administered once daily. Over the course of 48 weeks, various parameters that measure safety, tolerability and efficacy of the investigational drugs were measured and compared.
A Phase IV Randomized, Multicenter, Open-Label Study to Compare the Safety, Tolerability and Efficacy of Trizivir (abacavir 300mg, lamivudine 150mg, and zidovudine 300mg) BID vs Combivir (lamivudine 150mg and zidovudine 300mg) BID plus atazanavir 400mg QD in Antiretroviral Naive HIV-1 Infected Subjects over 48 Weeks
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trizivir | Drug | |||
| atazanavir | Drug | |||
| Combivir | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint was drug efficacy, measured as the proportion of study subjects who had plasma HIV-1 RNA less than 50 copies/mL at week 48 and did not meet the definition of virologic failure through this timepoint. | 48 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| % patients with plasma HIV-1 RNA <50 and <400 copies/mL at weeks 24 & 48; Change from BL in plasma HIV-1 RNA and CD4+ measures; AEs; Time to virologic failure | 48 Weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bakersfield | California | 93301 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19358725 | Derived | Kumar PN, Salvato P, LaMarca A, DeJesus E, Patel P, McClernon D, Florance A, Shaefer MS. A randomized, controlled trial of initial anti-retroviral therapy with abacavir/lamivudine/zidovudine twice-daily compared to atazanavir once-daily with lamivudine/zidovudine twice-daily in HIV-infected patients over 48 weeks (ESS100327, the ACTION Study). AIDS Res Ther. 2009 Apr 9;6:3. doi: 10.1186/1742-6405-6-3. |
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| Los Angeles |
| California |
| 90069 |
| United States |
| GSK Investigational Site | Oakland | California | 94609 | United States |
| GSK Investigational Site | San Francisco | California | 94121 | United States |
| GSK Investigational Site | Fort Collins | Colorado | 80528 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20007 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33145 | 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 | Miami | Florida | 33136 | United States |
| GSK Investigational Site | Miami Beach | Florida | 33140 | United States |
| GSK Investigational Site | Orlando | Florida | 32804 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30339 | United States |
| GSK Investigational Site | Decatur | Georgia | 30033 | United States |
| GSK Investigational Site | Chicago | Illinois | 60637 | United States |
| GSK Investigational Site | Wichita | Kansas | 67214 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40202 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70112 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70115 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70127-0800 | United States |
| GSK Investigational Site | St Louis | Missouri | 63139 | United States |
| GSK Investigational Site | East Orange | New Jersey | 7017 | United States |
| GSK Investigational Site | Hillsborough | New Jersey | 08876 | United States |
| GSK Investigational Site | Newark | New Jersey | 7102 | United States |
| GSK Investigational Site | Voorhees Township | New Jersey | 08043 | United States |
| GSK Investigational Site | Mount Vernon | New York | 10550 | United States |
| GSK Investigational Site | Valhalla | New York | 10595 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28209 | United States |
| GSK Investigational Site | Greenville | North Carolina | 27858-4354 | United States |
| GSK Investigational Site | Akron | Ohio | 44304 | United States |
| GSK Investigational Site | Portland | Oregon | 97219 | United States |
| GSK Investigational Site | Allentown | Pennsylvania | 18102 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19140 | United States |
| GSK Investigational Site | West Reading | Pennsylvania | 19611 | United States |
| GSK Investigational Site | Columbia | South Carolina | 29203 | United States |
| GSK Investigational Site | Greenville | South Carolina | 29605 | United States |
| GSK Investigational Site | Austin | Texas | 78705 | United States |
| GSK Investigational Site | Dallas | Texas | 75208 | United States |
| GSK Investigational Site | Dallas | Texas | 75246 | United States |
| GSK Investigational Site | Harlingen | Texas | 78550 | United States |
| GSK Investigational Site | Houston | Texas | 77027 | United States |
| GSK Investigational Site | Hampton | Virginia | 23666 | United States |
| GSK Investigational Site | Guadalajara | Jalisco | 44340 | Mexico |
| GSK Investigational Site | Monterrey | Nuevo León | 64460 | Mexico |
| 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 |
|---|---|
| C418262 | abacavir, lamivudine, and zidovudine drug combination |
| D000069446 | Atazanavir Sulfate |
| C109078 | lamivudine, zidovudine drug combination |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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