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This study is a 48-week study designed to evaluate the safety and efficacy of a fixed-dose combination tablet administered once-a-day versus the individual tablets administered twice-a-day within 3-drug combination regimens in ART (antiretroviral)-experienced HIV-1 infected patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abacavir/lamivudine | Drug | |||
| abacavir | Drug | |||
| lamivudine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of non-virologic failures through Week 48. Treatment-limiting adverse events over 48 weeks. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Viral load response at Week 24 and 48 T-cell count Disease progression Health outcomes Resistance | 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 Investigational Site | Phoenix | Arizona | 85006 | United States | ||
| GSK Investigational Site |
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| Fountain Valley |
| California |
| 92708 |
| United States |
| GSK Investigational Site | Long Beach | California | 90813 | United States |
| GSK Investigational Site | Los Angeles | California | 90028 | United States |
| GSK Investigational Site | Los Angeles | California | 90033 | United States |
| GSK Investigational Site | Sacramento | California | 95825 | United States |
| GSK Investigational Site | San Francisco | California | 94115-1931 | United States |
| GSK Investigational Site | Torrance | California | 90502 | United States |
| GSK Investigational Site | Denver | Colorado | 80205 | 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 | 20009 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33145 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33308 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33316 | United States |
| GSK Investigational Site | Fort Myers | Florida | 33901 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32206 | United States |
| GSK Investigational Site | Miami | Florida | 33133 | United States |
| GSK Investigational Site | Miami | Florida | 33136 | United States |
| GSK Investigational Site | Orlando | Florida | 32804 | United States |
| GSK Investigational Site | Orlando | Florida | 32806 | United States |
| GSK Investigational Site | Plantation | Florida | 33317 | United States |
| GSK Investigational Site | Tampa | Florida | 33602 | 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 | Augusta | Georgia | 30912 | United States |
| GSK Investigational Site | Decatur | Georgia | 30033 | United States |
| GSK Investigational Site | Wichita | Kansas | 67214 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21201 | United States |
| GSK Investigational Site | Hillsborough | New Jersey | 08844 | United States |
| GSK Investigational Site | Somers Point | New Jersey | 08244 | United States |
| GSK Investigational Site | New York | New York | 10011 | United States |
| GSK Investigational Site | New York | New York | 10014 | United States |
| GSK Investigational Site | New York | New York | 10019 | United States |
| GSK Investigational Site | Stony Brook | New York | 11794 | 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 | Akron | Ohio | 44304 | United States |
| GSK Investigational Site | Tulsa | Oklahoma | 74127 | United States |
| GSK Investigational Site | Hershey | Pennsylvania | 17033 | United States |
| GSK Investigational Site | Reading | Pennsylvania | 19601 | United States |
| GSK Investigational Site | Columbia | South Carolina | 29206-4713 | United States |
| GSK Investigational Site | Knoxville | Tennessee | 37916 | United States |
| GSK Investigational Site | Dallas | Texas | 75204 | United States |
| GSK Investigational Site | Dallas | Texas | 75208 | United States |
| GSK Investigational Site | Dallas | Texas | 75219 | United States |
| GSK Investigational Site | Dallas | Texas | 75246 | United States |
| GSK Investigational Site | Houston | Texas | 77004 | United States |
| GSK Investigational Site | Houston | Texas | 77027 | United States |
| GSK Investigational Site | Hampton | Virginia | 23666 | United States |
| GSK Investigational Site | San José | Costa Rica |
| GSK Investigational Site | Panama City | Panama |
| GSK Investigational Site | Ponce | 00731 | Puerto Rico |
| GSK Investigational Site | Rio Piedras | 925 | Puerto Rico |
| Result |
| Sosa N, Hill-Zabala C, Dejesus E, Herrera G, Florance A, Watson M, Vavro C, Shaefer M. Abacavir and lamivudine fixed-dose combination tablet once daily compared with abacavir and lamivudine twice daily in HIV-infected patients over 48 weeks (ESS30008, SEAL). J Acquir Immune Defic Syndr. 2005 Dec 1;40(4):422-7. doi: 10.1097/01.qai.0000184859.24071.bd. |
| Result | Sosa N, DeJesus E, Hill-Zabala C, et al. Abacavir + lamivudine (ABC/3TC) fixed-dose combination tablet once-daily compared with abacavir and lamivudine twice-daily in HIV-1-infected subjects (ESS30008). 7th International Congress on Drug Therapy in HIV Infection, Glasgow, UK, November 14-18, 2004 . [poster P45] |
| 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 |
|---|---|
| C492871 | abacavir, lamivudine drug combination |
| C106538 | abacavir |
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
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