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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00046176 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Drug: abacavir/lamivudine Drug: abacavir Drug: lamivudine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase III, 48-Week, Open-Label, Randomized, Multicenter Study of the Safety and Efficacy of the Abacavir/Lamivudine Fixed-Dose Combination Tablet Administered QD Versus Abacavir + Lamivudine Administered BID in Combination With a PI or NNRTI in Antiretroviral Experienced Patients. |
| Estimated Enrollment: | 240 |
| Study Start Date: | August 2002 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| GSK Investigational Site | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| GSK Investigational Site | |
| Los Angeles, California, United States, 90028 | |
| GSK Investigational Site | |
| Long Beach, California, United States, 90813 | |
| GSK Investigational Site | |
| Sacramento, California, United States, 95825 | |
| GSK Investigational Site | |
| San Francisco, California, United States, 94115-1931 | |
| GSK Investigational Site | |
| Los Angeles, California, United States, 90033 | |
| GSK Investigational Site | |
| Los Angeles, California, United States, 90028 | |
| GSK Investigational Site | |
| Torrance, California, United States, 90502 | |
| GSK Investigational Site | |
| Fountain Valley, California, United States, 92708 | |
| United States, Colorado | |
| GSK Investigational Site | |
| Denver, Colorado, United States, 80220 | |
| GSK Investigational Site | |
| Denver, Colorado, United States, 80205 | |
| United States, District of Columbia | |
| GSK Investigational Site | |
| Washington, District of Columbia, United States, 20007 | |
| GSK Investigational Site | |
| Washington, District of Columbia, United States, 20009 | |
| United States, Florida | |
| GSK Investigational Site | |
| Tampa, Florida, United States, 33614 | |
| GSK Investigational Site | |
| Fort Lauderdale, Florida, United States, 33316 | |
| GSK Investigational Site | |
| Miami, Florida, United States, 33133 | |
| GSK Investigational Site | |
| Orlando, Florida, United States, 32804 | |
| GSK Investigational Site | |
| Fort Lauderdale, Florida, United States, 33308 | |
| GSK Investigational Site | |
| Fort Myers, Florida, United States, 33901 | |
| GSK Investigational Site | |
| Fort Lauderdale, Florida, United States, 33145 | |
| GSK Investigational Site | |
| Jacksonville, Florida, United States, 32206 | |
| GSK Investigational Site | |
| Orlando, Florida, United States, 32806 | |
| GSK Investigational Site | |
| Miami, Florida, United States, 33136 | |
| GSK Investigational Site | |
| Plantation, Florida, United States, 33317 | |
| GSK Investigational Site | |
| Tampa, Florida, United States, 33602 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30308 | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30339 | |
| GSK Investigational Site | |
| Decatur, Georgia, United States, 30033 | |
| GSK Investigational Site | |
| Augusta, Georgia, United States, 30912 | |
| United States, Kansas | |
| GSK Investigational Site | |
| Wichita, Kansas, United States, 67214 | |
| United States, Maryland | |
| GSK Investigational Site | |
| Baltimore, Maryland, United States, 21201 | |
| GSK Investigational Site | |
| Baltimore, Maryland, United States, 21201 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Hillsborough, New Jersey, United States, 08844 | |
| GSK Investigational Site | |
| Somers Point, New Jersey, United States, 08244 | |
| United States, New York | |
| GSK Investigational Site | |
| Stony Brook, New York, United States, 11794 | |
| GSK Investigational Site | |
| New York, New York, United States, 10011 | |
| GSK Investigational Site | |
| New York, New York, United States, 10014 | |
| GSK Investigational Site | |
| New York, New York, United States, 10019 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Charlotte, North Carolina, United States, 28209 | |
| GSK Investigational Site | |
| Greenville, North Carolina, United States, 27858 | |
| GSK Investigational Site | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Akron, Ohio, United States, 44304 | |
| United States, Oklahoma | |
| GSK Investigational Site | |
| Tulsa, Oklahoma, United States, 74127 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Reading, Pennsylvania, United States, 19601 | |
| GSK Investigational Site | |
| Hershey, Pennsylvania, United States, 17033 | |
| United States, South Carolina | |
| GSK Investigational Site | |
| Columbia, South Carolina, United States, 29206-4713 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Knoxville, Tennessee, United States, 37916 | |
| United States, Texas | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77027 | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75208 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77004 | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75204 | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75219 | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75246 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Hampton, Virginia, United States, 23666 | |
| Costa Rica | |
| GSK Investigational Site | |
| San Jose, Costa Rica | |
| Panama, Panamá | |
| GSK Investigational Site | |
| Panama City, Panamá, Panama | |
| Puerto Rico | |
| GSK Investigational Site | |
| Rio Piedras, Puerto Rico, 925 | |
| GSK Investigational Site | |
| Ponce, Puerto Rico, 00731 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | ESS30008 |
| Study First Received: | September 20, 2002 |
| Last Updated: | October 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00046176 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1
Abacavir
Lamivudine
Antiretroviral-experienced |
|
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Lamivudine Enzyme Inhibitors Infection Antiviral Agents |
Pharmacologic Actions Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Abacavir Retroviridae Infections Nucleic Acid Synthesis Inhibitors |