HIV Infection Clinical Trial
Official title:
See Detailed Description
| Verified date | September 2010 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 900 |
| Est. completion date | October 2005 |
| Est. primary completion date | October 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Have HIV-1 infection. - Had not received any prior HIV treatment for more than 14 days. - At least 1000 copies of HIV-1 RNA. - Willing to provide signed informed consent. Exclusion Criteria: - Enrolled in other investigational drug studies. - Female subjects who are pregnant or breastfeeding. - History of allergy or hypersensitivity to abacavir or lamivudine. - Certain medical conditions that would make subjects ineligible. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | GSK Investigational Site | Albany | New York |
| United States | GSK Investigational Site | Annandale | Virginia |
| United States | GSK Investigational Site | Arleta | California |
| United States | GSK Investigational Site | Arlington | Texas |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Austell | Georgia |
| United States | GSK Investigational Site | Austin | Texas |
| United States | GSK Investigational Site | Baltimore | Maryland |
| United States | GSK Investigational Site | Baltimore | Maryland |
| United States | GSK Investigational Site | Baltimore | Maryland |
| United States | GSK Investigational Site | Baltimore | Maryland |
| United States | GSK Investigational Site | Baton Rouge | Louisiana |
| United States | GSK Investigational Site | Berkeley | Michigan |
| United States | GSK Investigational Site | Bethesda | Maryland |
| United States | GSK Investigational Site | Beverly Hills | California |
| United States | GSK Investigational Site | Beverly Hills | California |
| United States | GSK Investigational Site | Boise | Idaho |
| United States | GSK Investigational Site | Bronx | New York |
| United States | GSK Investigational Site | Brooklyn | New York |
| United States | GSK Investigational Site | Brooklyn | New York |
| United States | GSK Investigational Site | Brooklyn | New York |
| United States | GSK Investigational Site | Brooklyn | New York |
| United States | GSK Investigational Site | Brooklyn | New York |
| United States | GSK Investigational Site | Charlotte | North Carolina |
| United States | GSK Investigational Site | Chesterfield | Missouri |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Cleveland | Ohio |
| United States | GSK Investigational Site | Clinton | Maryland |
| United States | GSK Investigational Site | Columbia | Missouri |
| United States | GSK Investigational Site | Columbus | Georgia |
| United States | GSK Investigational Site | Coral Gables | Florida |
| United States | GSK Investigational Site | Coral Springs | Florida |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Danville | Pennsylvania |
| United States | GSK Investigational Site | Daytona Beach | Florida |
| United States | GSK Investigational Site | Decatur | Georgia |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | Des Moines | Iowa |
| United States | GSK Investigational Site | East Orange | New Jersey |
| United States | GSK Investigational Site | El Paso | Texas |
| United States | GSK Investigational Site | Elgin | Illinois |
| United States | GSK Investigational Site | Englewood | New Jersey |
| United States | GSK Investigational Site | Fairfax | Virginia |
| United States | GSK Investigational Site | Fort Lauderdale | Florida |
| United States | GSK Investigational Site | Fort Lauderdale | Florida |
| United States | GSK Investigational Site | Fort Lauderdale | Florida |
| United States | GSK Investigational Site | Fort Myers | Florida |
| United States | GSK Investigational Site | Fresno | California |
| United States | GSK Investigational Site | Gainesville | Florida |
| United States | GSK Investigational Site | Galloway | New Jersey |
| United States | GSK Investigational Site | Galveston | Texas |
| United States | GSK Investigational Site | Glastonbury | Connecticut |
| United States | GSK Investigational Site | Glendale | Arizona |
| United States | GSK Investigational Site | Grand Rapids | Michigan |
| United States | GSK Investigational Site | Great Neck | New York |
| United States | GSK Investigational Site | Greenville | South Carolina |
| United States | GSK Investigational Site | Henderson | Kentucky |
| United States | GSK Investigational Site | Henderson | Nevada |
| United States | GSK Investigational Site | Hoboken | New Jersey |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Huntersville | North Carolina |
| United States | GSK Investigational Site | Indianapolis | Indiana |
| United States | GSK Investigational Site | Inmokalee | Florida |
| United States | GSK Investigational Site | Jersey City | New Jersey |
| United States | GSK Investigational Site | Jersey City | New Jersey |
| United States | GSK Investigational Site | Johnson City | Tennessee |
| United States | GSK Investigational Site | Joliet | Illinois |
| United States | GSK Investigational Site | Kansas City | Missouri |
| United States | GSK Investigational Site | Kansas City | Missouri |
| United States | GSK Investigational Site | Key West | Florida |
| United States | GSK Investigational Site | Lansing | Michigan |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Lawrenceville | Georgia |
| United States | GSK Investigational Site | Lebanon | New Hampshire |
| United States | GSK Investigational Site | Long Beach | California |
| United States | GSK Investigational Site | Long Beach | California |
| United States | GSK Investigational Site | Long Beach | California |
| United States | GSK Investigational Site | Longview | Texas |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Louisville | Kentucky |
| United States | GSK Investigational Site | Lowell | Massachusetts |
| United States | GSK Investigational Site | Manhasset | New York |
| United States | GSK Investigational Site | Melbourne | Florida |
| United States | GSK Investigational Site | Memphis | Tennessee |
| United States | GSK Investigational Site | Memphis | Tennessee |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Miami Beach | Florida |
| United States | GSK Investigational Site | Milwaukee | Wisconsin |
| United States | GSK Investigational Site | Montgomery | Alabama |
| United States | GSK Investigational Site | New Haven | Connecticut |
| United States | GSK Investigational Site | New Orleans | Louisiana |
| United States | GSK Investigational Site | New Orleans | Louisiana |
| United States | GSK Investigational Site | New Orleans | Louisiana |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | Newark | New Jersey |
| United States | GSK Investigational Site | Newark | New Jersey |
| United States | GSK Investigational Site | Newark | New Jersey |
| United States | GSK Investigational Site | Newport Beach | California |
| United States | GSK Investigational Site | North Miami | Florida |
| United States | GSK Investigational Site | Norwalk | Connecticut |
| United States | GSK Investigational Site | Oakland | California |
| United States | GSK Investigational Site | Oakland | California |
| United States | GSK Investigational Site | Orlando | Florida |
| United States | GSK Investigational Site | Orlando | Florida |
| United States | GSK Investigational Site | Orlando | Florida |
| United States | GSK Investigational Site | Palm Springs | California |
| United States | GSK Investigational Site | Pampano | Florida |
| United States | GSK Investigational Site | Panorama City | California |
| United States | GSK Investigational Site | Paramount | California |
| United States | GSK Investigational Site | Pembroke Pines | Florida |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Plantation | Florida |
| United States | GSK Investigational Site | Pompano Beach | Florida |
| United States | GSK Investigational Site | Port St. Lucie | Florida |
| United States | GSK Investigational Site | Portland | Oregon |
| United States | GSK Investigational Site | Reading | Pennsylvania |
| United States | GSK Investigational Site | Richmond | Virginia |
| United States | GSK Investigational Site | Riverdale | Georgia |
| United States | GSK Investigational Site | Riverside | California |
| United States | GSK Investigational Site | Salinas | California |
| United States | GSK Investigational Site | Salt Lake City | Utah |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Francisco | California |
| United States | GSK Investigational Site | San Francisco | California |
| United States | GSK Investigational Site | Santa Fe | New Mexico |
| United States | GSK Investigational Site | Santa Rosa | California |
| United States | GSK Investigational Site | Sarasota | Florida |
| United States | GSK Investigational Site | Silver Spring | Maryland |
| United States | GSK Investigational Site | Somers Point | New Jersey |
| United States | GSK Investigational Site | South Miami | Florida |
| United States | GSK Investigational Site | Spartanburg | South Carolina |
| United States | GSK Investigational Site | Spokane | Washington |
| United States | GSK Investigational Site | Springfield | Massachusetts |
| United States | GSK Investigational Site | St. Louis | Michigan |
| United States | GSK Investigational Site | St. Petersburg | Florida |
| United States | GSK Investigational Site | Stamford | Connecticut |
| United States | GSK Investigational Site | Staten Island | New York |
| United States | GSK Investigational Site | Stratford | Connecticut |
| United States | GSK Investigational Site | Tallahassee | Florida |
| United States | GSK Investigational Site | Tamarac | Florida |
| United States | GSK Investigational Site | Tampa | Florida |
| United States | GSK Investigational Site | Tarzana | California |
| United States | GSK Investigational Site | Tarzana | California |
| United States | GSK Investigational Site | Tucson | Arizona |
| United States | GSK Investigational Site | Tyler | Texas |
| United States | GSK Investigational Site | Washington | District of Columbia |
| United States | GSK Investigational Site | West Palm Beach | Florida |
| United States | GSK Investigational Site | West Palm Beach | Florida |
| United States | GSK Investigational Site | Westfield | New Jersey |
| United States | GSK Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The occurrence of treatment-limiting adverse events after starting study drugs. | |||
| Secondary | occurrence of abacavir HSR | |||
| Secondary | completion of educational training | |||
| Secondary | subject satisfaction with treatment | |||
| Secondary | adherence to study medications | |||
| Secondary | change in HIV-1 RNA from BL | |||
| Secondary | change in CD4 measure from BL. |
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