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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00038506 |
This study is a 48-week study to evaluate the efficacy and safety of an investigational regimen combining FDA approved HIV drugs in antiretroviral-experienced subjects failing on their first highly active antiretroviral therapy regimen.
Condition | Intervention | Phase |
---|---|---|
HIV Infection |
Drug: abacavir/lamivudine/zidovudine Drug: tenofovir |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase IV, Open-Label, Multicenter Study of Treatment With TRIZIVIR (Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg) Twice Daily and Tenofovir 300mg Once-Daily for 48 Weeks in HIV-Infected Subjects Experiencing Early Virologic Failure (ZIAGEN Intensification Protocol) |
Estimated Enrollment: | 100 |
Study Start Date: | March 2002 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
GSK Investigational Site | |
San Rafael, California, United States, 94903 | |
GSK Investigational Site | |
Los Angeles, California, United States, 90027 | |
United States, Florida | |
GSK Investigational Site | |
Fort Lauderdale, Florida, United States, 33145 | |
GSK Investigational Site | |
Lake Worth, Florida, United States, 33463 | |
GSK Investigational Site | |
Miami, Florida, United States, 33136 | |
GSK Investigational Site | |
North Miami, Florida, United States, 33161 | |
GSK Investigational Site | |
Orlando, Florida, United States, 32804 | |
GSK Investigational Site | |
Miami Beach, Florida, United States, 33139 | |
GSK Investigational Site | |
Jacksonville, Florida, United States, 32206 | |
GSK Investigational Site | |
Tallahassee, Florida, United States, 32303 | |
United States, Georgia | |
GSK Investigational Site | |
Decatur, Georgia, United States, 30033 | |
GSK Investigational Site | |
Atlanta, Georgia, United States, 30309 | |
United States, Illinois | |
GSK Investigational Site | |
Chicago, Illinois, United States, 60657 | |
GSK Investigational Site | |
Maywood, Illinois, United States, 60153 | |
United States, Indiana | |
GSK Investigational Site | |
Lafayette, Indiana, United States, 47904 | |
United States, Michigan | |
GSK Investigational Site | |
Berkeley, Michigan, United States, 48072 | |
United States, New York | |
GSK Investigational Site | |
Valhalla, New York, United States, 10595 | |
GSK Investigational Site | |
Bronx, New York, United States, 10461 | |
GSK Investigational Site | |
New York, New York, United States, 10014 | |
United States, Oklahoma | |
GSK Investigational Site | |
Tulsa, Oklahoma, United States, 74114 | |
United States, Texas | |
GSK Investigational Site | |
Arlington, Texas, United States, 76015 | |
GSK Investigational Site | |
Dallas, Texas, United States, 75246 | |
GSK Investigational Site | |
Dallas, Texas, United States, 75216 | |
GSK Investigational Site | |
Houston, Texas, United States, 77004 | |
GSK Investigational Site | |
Dallas, Texas, United States, 75208 | |
United States, Washington | |
GSK Investigational Site | |
Seattle, Washington, United States, 98104 | |
United States, Wisconsin | |
GSK Investigational Site | |
Green Bay, Wisconsin, United States, 54301 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | ESS 30005 |
Study First Received: | May 31, 2002 |
Last Updated: | May 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00038506 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HIV-1
TRIZIVIR
Tenofovir |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Zidovudine Lamivudine Antiviral Agents Immunologic Deficiency Syndromes |
Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Tenofovir Abacavir Retroviridae Infections Tenofovir disoproxil |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Tenofovir Abacavir Retroviridae Infections |
Nucleic Acid Synthesis Inhibitors Tenofovir disoproxil RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |