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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00053638 |
Purpose
This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Drug: efavirenz Drug: tenofovir Drug: abacavir/lamivudine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase III, Randomized, Open-Label, Multicenter Study of the Safety and Efficacy of Efavirenz Versus Tenofovir When Administered in Combination With the Abacavir/Lamivudine Fixed-Dose Combination Tablet as a Once-Daily Regimen in Antiretroviral-Naive HIV-1 Infected Subjects. |
| Estimated Enrollment: | 345 |
| Study Start Date: | February 2003 |
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, 90033 | |
| GSK Investigational Site | |
| Fountain Valley, California, United States, 92708 | |
| GSK Investigational Site | |
| San Francisco, California, United States, 94115-1931 | |
| United States, Colorado | |
| GSK Investigational Site | |
| Denver, Colorado, United States, 80205 | |
| GSK Investigational Site | |
| Fort Collins, Colorado, United States, 80528 | |
| GSK Investigational Site | |
| Denver, Colorado, United States, 80220 | |
| United States, District of Columbia | |
| GSK Investigational Site | |
| Washington, District of Columbia, United States, 20007-2113 | |
| GSK Investigational Site | |
| Washington, District of Columbia, United States, 20009 | |
| GSK Investigational Site | |
| Washington, District of Columbia, United States, 20036 | |
| United States, Florida | |
| GSK Investigational Site | |
| Orlando, Florida, United States, 32806 | |
| 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 | |
| Tampa, Florida, United States, 33602 | |
| GSK Investigational Site | |
| North Miami, Florida, United States, 33161 | |
| GSK Investigational Site | |
| Fort Lauderdale, Florida, United States, 33316 | |
| GSK Investigational Site | |
| Vero Beach, Florida, United States, 32960 | |
| GSK Investigational Site | |
| Orlando, Florida, United States, 32804 | |
| GSK Investigational Site | |
| Miami, Florida, United States, 33136 | |
| GSK Investigational Site | |
| Miami, Florida, United States, 33133 | |
| GSK Investigational Site | |
| Jacksonville, Florida, United States, 32206 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Decatur, Georgia, United States, 30033 | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30339 | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30309 | |
| United States, Illinois | |
| GSK Investigational Site | |
| Chicago, Illinois, United States, 60657 | |
| United States, Indiana | |
| GSK Investigational Site | |
| Indianapolis, Indiana, United States, 46202 - 5124 | |
| United States, Kansas | |
| GSK Investigational Site | |
| Wichita, Kansas, United States, 67214 | |
| United States, Louisiana | |
| GSK Investigational Site | |
| New Orleans, Louisiana, United States, 70127-0800 | |
| GSK Investigational Site | |
| New Orleans, Louisiana, United States, 70115 | |
| United States, Minnesota | |
| GSK Investigational Site | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Hillsborough, New Jersey, United States, 08844 | |
| United States, New Mexico | |
| GSK Investigational Site | |
| Albuquerque, New Mexico, United States, 87131-0001 | |
| United States, New York | |
| GSK Investigational Site | |
| Stony Brook, New York, United States, 11794 | |
| GSK Investigational Site | |
| Buffalo, New York, United States, 14215 | |
| GSK Investigational Site | |
| New York, New York, United States, 10014 | |
| GSK Investigational Site | |
| New York, New York, United States, 10011 | |
| GSK Investigational Site | |
| Albany, New York, United States, 12208 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Charlotte, North Carolina, United States, 28209 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Cincinnati, Ohio, United States, 45267-0405 | |
| United States, Oregon | |
| GSK Investigational Site | |
| Portland, Oregon, United States, 97210 | |
| GSK Investigational Site | |
| Portland, Oregon, United States, 97219 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| GSK Investigational Site | |
| Reading, Pennsylvania, United States, 19601 | |
| GSK Investigational Site | |
| Hershey, Pennsylvania, United States, 17033 | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| United States, Rhode Island | |
| GSK Investigational Site | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| GSK Investigational Site | |
| Columbia, South Carolina, United States, 29206-4713 | |
| United States, Texas | |
| GSK Investigational Site | |
| Tyler, Texas, United States, 75708 | |
| GSK Investigational Site | |
| Fort Worth, Texas, United States, 76104 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77030 | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75246 | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75208 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Hampton, Virginia, United States, 23666 | |
| GSK Investigational Site | |
| Lynchburg, Virginia, United States, 24501 | |
| United States, Washington | |
| GSK Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| 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 |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | ESS30009 |
| Study First Received: | February 4, 2003 |
| Last Updated: | October 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00053638 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1
Efavirenz
Tenofovir |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Tenofovir Abacavir Retroviridae Infections Nucleic Acid Synthesis Inhibitors Tenofovir disoproxil |
Efavirenz 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 |
