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This study was designed to evaluate if subjects who took 600 mg of abacavir and 300 mg of lamivudine once-daily as a single tablet were just as likely to have adverse events compared to subjects who took 300 mg of abacavir and 150 mg of lamivudine administered as separate tablets twice-daily.
A phase IIIB randomized, open-label, multicenter, parallel-arm study to evaluate the short-term safety and tolerability of the abacavir/lamivudine fixed-dose combination tablet administered once-daily or the separate abacavir and lamivudine tablets administered twice-daily, as part of a three or four-drug regimen, in antiretroviral naive HIV-1 infected subjects.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abacavir/Lamivudine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of treatment-limiting adverse events after starting study drugs. |
| Measure | Description | Time Frame |
|---|---|---|
| occurrence of abacavir HSR | ||
| completion of educational training | ||
| subject satisfaction with treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, PharmD | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Montgomery | Alabama | 36105 | United States | ||
| GSK Investigational Site |
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| adherence to study medications |
| change in HIV-1 RNA from BL |
| change in CD4 measure from BL. |
| Glendale |
| Arizona |
| 85306 |
| United States |
| GSK Investigational Site | Phoenix | Arizona | 85006 | United States |
| GSK Investigational Site | Phoenix | Arizona | 85015 | United States |
| GSK Investigational Site | Tucson | Arizona | 85745 | United States |
| GSK Investigational Site | Arleta | California | 91331 | United States |
| GSK Investigational Site | Beverly Hills | California | 90210 | United States |
| GSK Investigational Site | Beverly Hills | California | 90211 | United States |
| GSK Investigational Site | Fresno | California | 93720 | United States |
| GSK Investigational Site | Long Beach | California | 90801 | United States |
| GSK Investigational Site | Long Beach | California | 90806 | United States |
| GSK Investigational Site | Long Beach | California | 90813 | United States |
| GSK Investigational Site | Los Angeles | California | 90022 | United States |
| GSK Investigational Site | Los Angeles | California | 90027 | United States |
| GSK Investigational Site | Los Angeles | California | 90028 | United States |
| GSK Investigational Site | Los Angeles | California | 90048 | United States |
| GSK Investigational Site | Los Angeles | California | 90067 | United States |
| GSK Investigational Site | Newport Beach | California | 92663 | United States |
| GSK Investigational Site | Oakland | California | 94602 | United States |
| GSK Investigational Site | Oakland | California | 94609 | United States |
| GSK Investigational Site | Palm Springs | California | 92262 | United States |
| GSK Investigational Site | Panorama City | California | 91402 | United States |
| GSK Investigational Site | Paramount | California | 90723 | United States |
| GSK Investigational Site | Riverside | California | 92507 | United States |
| GSK Investigational Site | Salinas | California | 93912 | United States |
| GSK Investigational Site | San Francisco | California | 94102 | United States |
| GSK Investigational Site | San Francisco | California | 94114 | United States |
| GSK Investigational Site | Santa Rosa | California | 95404 | United States |
| GSK Investigational Site | Tarzana | California | 30342 | United States |
| GSK Investigational Site | Tarzana | California | 91356 | United States |
| GSK Investigational Site | Denver | Colorado | 80204 | United States |
| GSK Investigational Site | Denver | Colorado | 80205 | United States |
| GSK Investigational Site | Denver | Colorado | 80206 | United States |
| GSK Investigational Site | Glastonbury | Connecticut | 06033 | United States |
| GSK Investigational Site | New Haven | Connecticut | 06520 | United States |
| GSK Investigational Site | Norwalk | Connecticut | 06851 | United States |
| GSK Investigational Site | Stamford | Connecticut | 06902 | United States |
| GSK Investigational Site | Stratford | Connecticut | 06614 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20037 | United States |
| GSK Investigational Site | Coral Gables | Florida | 33134 | United States |
| GSK Investigational Site | Coral Springs | Florida | 33065 | United States |
| GSK Investigational Site | Daytona Beach | Florida | 32114 | 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 | Gainesville | Florida | 32601 | United States |
| GSK Investigational Site | Inmokalee | Florida | 34142 | United States |
| GSK Investigational Site | Key West | Florida | 33040 | United States |
| GSK Investigational Site | Melbourne | Florida | 32935 | United States |
| GSK Investigational Site | Miami | Florida | 33133 | United States |
| GSK Investigational Site | Miami | Florida | 33176 | United States |
| GSK Investigational Site | Miami Beach | Florida | 33139 | United States |
| GSK Investigational Site | North Miami | Florida | 33161 | United States |
| GSK Investigational Site | Orlando | Florida | 32803 | United States |
| GSK Investigational Site | Orlando | Florida | 32804 | United States |
| GSK Investigational Site | Orlando | Florida | 32806 | United States |
| GSK Investigational Site | Pampano | Florida | 33062 | United States |
| GSK Investigational Site | Pembroke Pines | Florida | 33024 | United States |
| GSK Investigational Site | Plantation | Florida | 33317 | United States |
| GSK Investigational Site | Pompano Beach | Florida | 33062 | United States |
| GSK Investigational Site | Port Saint Lucie | Florida | 34952 | United States |
| GSK Investigational Site | Sarasota | Florida | 34239 | United States |
| GSK Investigational Site | South Miami | Florida | 33143 | United States |
| GSK Investigational Site | St. Petersburg | Florida | 33710 | United States |
| GSK Investigational Site | Tallahassee | Florida | 32308 | United States |
| GSK Investigational Site | Tamarac | Florida | 33321 | United States |
| GSK Investigational Site | Tampa | Florida | 33614 | United States |
| GSK Investigational Site | West Palm Beach | Florida | 33401 | United States |
| GSK Investigational Site | West Palm Beach | Florida | 33408 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30308/30309 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30309 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30312 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30318 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30329 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30342 | United States |
| GSK Investigational Site | Austell | Georgia | 30106 | United States |
| GSK Investigational Site | Columbus | Georgia | 31906 | United States |
| GSK Investigational Site | Decatur | Georgia | 30033 | United States |
| GSK Investigational Site | Lawrenceville | Georgia | 30045 | United States |
| GSK Investigational Site | Riverdale | Georgia | 30274 | United States |
| GSK Investigational Site | Boise | Idaho | 83704 | United States |
| GSK Investigational Site | Chicago | Illinois | 60643 | United States |
| GSK Investigational Site | Elgin | Illinois | 60120 | United States |
| GSK Investigational Site | Joliet | Illinois | 60432 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46204 | United States |
| GSK Investigational Site | Des Moines | Iowa | 50309-1426 | United States |
| GSK Investigational Site | Henderson | Kentucky | 42420 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40202 | United States |
| GSK Investigational Site | Baton Rouge | Louisiana | 70816 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70115 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70117 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70121 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21201 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21209 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21218 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21229-5299 | United States |
| GSK Investigational Site | Bethesda | Maryland | 20816 | United States |
| GSK Investigational Site | Clinton | Maryland | 20735 | United States |
| GSK Investigational Site | Silver Spring | Maryland | 20910 | United States |
| GSK Investigational Site | Lowell | Massachusetts | 01854 | United States |
| GSK Investigational Site | Springfield | Massachusetts | 01107 | United States |
| GSK Investigational Site | Berkeley | Michigan | 48072 | United States |
| GSK Investigational Site | Grand Rapids | Michigan | 49503 | United States |
| GSK Investigational Site | Lansing | Michigan | 48910 | United States |
| GSK Investigational Site | Saint Louis | Michigan | 63117 | United States |
| GSK Investigational Site | Chesterfield | Missouri | 63017 | United States |
| GSK Investigational Site | Columbia | Missouri | 65212 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64112 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64132 | United States |
| GSK Investigational Site | Henderson | Nevada | 89015 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 79102 | United States |
| GSK Investigational Site | Lebanon | New Hampshire | 03756 | United States |
| GSK Investigational Site | East Orange | New Jersey | 07017 | United States |
| GSK Investigational Site | Englewood | New Jersey | 07631 | United States |
| GSK Investigational Site | Galloway | New Jersey | 08205 | United States |
| GSK Investigational Site | Hoboken | New Jersey | 07030 | United States |
| GSK Investigational Site | Jersey City | New Jersey | 07304 | United States |
| GSK Investigational Site | Jersey City | New Jersey | 07306 | United States |
| GSK Investigational Site | Newark | New Jersey | 07101-1709 | United States |
| GSK Investigational Site | Newark | New Jersey | 07102 | United States |
| GSK Investigational Site | Newark | New Jersey | 07112 | United States |
| GSK Investigational Site | Somers Point | New Jersey | 08244 | United States |
| GSK Investigational Site | Westfield | New Jersey | 07090 | United States |
| GSK Investigational Site | Santa Fe | New Mexico | 87505 | United States |
| GSK Investigational Site | Albany | New York | 12208 | United States |
| GSK Investigational Site | Brooklyn | New York | 11201 | United States |
| GSK Investigational Site | Brooklyn | New York | 11212 | United States |
| GSK Investigational Site | Brooklyn | New York | 11215 | United States |
| GSK Investigational Site | Brooklyn | New York | 11220 | United States |
| GSK Investigational Site | Brooklyn | New York | 11237 | United States |
| GSK Investigational Site | Great Neck | New York | 10020 | United States |
| GSK Investigational Site | Manhasset | New York | 11030 | United States |
| GSK Investigational Site | New York | New York | 10003 | United States |
| GSK Investigational Site | New York | New York | 10010 | United States |
| GSK Investigational Site | New York | New York | 10011 | United States |
| GSK Investigational Site | New York | New York | 10016 | United States |
| GSK Investigational Site | New York | New York | 10019 | United States |
| GSK Investigational Site | New York | New York | 10022 | United States |
| GSK Investigational Site | New York | New York | 10025 | United States |
| GSK Investigational Site | Staten Island | New York | 10304 | United States |
| GSK Investigational Site | The Bronx | New York | 10457 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28211 | United States |
| GSK Investigational Site | Huntersville | North Carolina | 28078 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44109 | United States |
| GSK Investigational Site | Portland | Oregon | 97209 | United States |
| GSK Investigational Site | Danville | Pennsylvania | 17822 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19103 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19121 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19131 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19143 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19146 | United States |
| GSK Investigational Site | Reading | Pennsylvania | 19601 | United States |
| GSK Investigational Site | Greenville | South Carolina | 29605 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | Johnson City | Tennessee | 37614 | United States |
| GSK Investigational Site | Memphis | Tennessee | 38104 | United States |
| GSK Investigational Site | Memphis | Tennessee | 38120 | United States |
| GSK Investigational Site | Arlington | Texas | 76015 | United States |
| GSK Investigational Site | Austin | Texas | 78705 | United States |
| GSK Investigational Site | Dallas | Texas | 75219 | United States |
| GSK Investigational Site | Dallas | Texas | 75235 | United States |
| GSK Investigational Site | El Paso | Texas | 79905 | United States |
| GSK Investigational Site | Galveston | Texas | 77555-0188 | United States |
| GSK Investigational Site | Houston | Texas | 77004 | United States |
| GSK Investigational Site | Houston | Texas | 77009 | United States |
| GSK Investigational Site | Houston | Texas | 77027 | United States |
| GSK Investigational Site | Houston | Texas | 77098 | United States |
| GSK Investigational Site | Longview | Texas | 75604 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Tyler | Texas | 75708 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84132 | United States |
| GSK Investigational Site | Annandale | Virginia | 22003 | United States |
| GSK Investigational Site | Fairfax | Virginia | 22030 | United States |
| GSK Investigational Site | Richmond | Virginia | 23224 | United States |
| GSK Investigational Site | Spokane | Washington | 99204 | United States |
| GSK Investigational Site | Milwaukee | Wisconsin | 53212 | United States |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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