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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00440947 |
Purpose
This study was designed to test the efficacy, safety, tolerability and durability of the antiviral response between atazanavir (ATV) + ritonavir (RTV) + abacavir/lamivudine(ABC/3TC) each administered once daily (QD) for 36 weeks followed by randomization to either a simplification regimen of ATV or continuation of ATV+RTV for an additional 48 weeks, each in combination with ABC/3TC in antiretroviral (ART)-naive, HIV-1 infected, HLA-B*5701 negative subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Drug: ABC/3TC + ATV/r x 36wks followed by ABC/3TC + ATV x 48wks Drug: ABC/3TC + ATV/r x 36wks followed by ABC/3TC + ATV/r x 48wks |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | See Detailed Description |
| Enrollment: | 500 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | April 2009 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Safety and Efficacy of an Initial Regimen of Atazanavir + Ritonavir + the Abacavir/Lamivudine Fixed-Dose Combination Tablet (ABC/3TC FDC) for 36 weeks followed by Simplification to Atazanavir with ABC/3TC FDC or Maintenance of the Initial Regimen for an Additional 48 weeks in Antiretroviral-Naive HIV-1 Infected HLA-B*5701 Negative Subjects
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, 85012 | |
| United States, California | |
| GSK Investigational Site | |
| Long Beach, California, United States, 90813 | |
| GSK Investigational Site | |
| Los Angeles, California, United States, 90033 | |
| GSK Investigational Site | |
| Garden Grove, California, United States, 92845 | |
| GSK Investigational Site | |
| Los Angeles, California, United States, 90022 | |
| GSK Investigational Site | |
| Oakland, California, United States, 94609 | |
| GSK Investigational Site | |
| Newport Beach, California, United States, 92663 | |
| United States, Colorado | |
| GSK Investigational Site | |
| Denver, Colorado, United States, 80220 | |
| United States, Connecticut | |
| GSK Investigational Site | |
| Glastonbury, Connecticut, United States, 06033 | |
| United States, District of Columbia | |
| GSK Investigational Site | |
| Washington, District of Columbia, United States, 20009 | |
| GSK Investigational Site | |
| Washington, District of Columbia, United States, 20036 | |
| GSK Investigational Site | |
| Washington, District of Columbia, United States, 20037 | |
| GSK Investigational Site | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| GSK Investigational Site | |
| Hollywood, Florida, United States, 33020 | |
| GSK Investigational Site | |
| Sarasota, Florida, United States, 34243 | |
| GSK Investigational Site | |
| Tampa, Florida, United States, 33607 | |
| GSK Investigational Site | |
| Fort Lauderdale, Florida, United States, 33316 | |
| GSK Investigational Site | |
| Port St. Lucie, Florida, United States, 34952 | |
| GSK Investigational Site | |
| Plantation, Florida, United States, 33317 | |
| GSK Investigational Site | |
| Fort Lauderdale, Florida, United States, 33308 | |
| GSK Investigational Site | |
| Tampa, Florida, United States, 33602 | |
| GSK Investigational Site | |
| Orlando, Florida, United States, 32803 | |
| GSK Investigational Site | |
| Miami, Florida, United States, 33101 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30308 | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30339 | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30309 | |
| GSK Investigational Site | |
| Augusta, Georgia, United States, 30912 | |
| GSK Investigational Site | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| GSK Investigational Site | |
| Chicago, Illinois, United States, 60657 | |
| GSK Investigational Site | |
| Chicago, Illinois, United States, 60637 | |
| GSK Investigational Site | |
| Maywood, Illinois, United States, 60153 | |
| United States, Kentucky | |
| GSK Investigational Site | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Maryland | |
| GSK Investigational Site | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| GSK Investigational Site | |
| Boston, Massachusetts, United States, 02215 | |
| GSK Investigational Site | |
| Springfield, Massachusetts, United States, 01107 | |
| GSK Investigational Site | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| GSK Investigational Site | |
| Detroit, Michigan, United States, 48202 | |
| United States, Minnesota | |
| GSK Investigational Site | |
| Minneapolis, Minnesota, United States, 55404 | |
| GSK Investigational Site | |
| Minneapolis, Minnesota, United States, 55415 | |
| United States, Missouri | |
| GSK Investigational Site | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Somers Point, New Jersey, United States, 08244 | |
| GSK Investigational Site | |
| Hillsborough, New Jersey, United States, 08844 | |
| GSK Investigational Site | |
| Newark, New Jersey, United States, 07102 | |
| United States, New York | |
| GSK Investigational Site | |
| New York, New York, United States, 10011 | |
| GSK Investigational Site | |
| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Charlotte, North Carolina, United States, 28209 | |
| GSK Investigational Site | |
| Greenville, North Carolina, United States, 27834 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Toledo, Ohio, United States, 43614 | |
| GSK Investigational Site | |
| Akron, Ohio, United States, 44304 | |
| United States, Oregon | |
| GSK Investigational Site | |
| Portland, Oregon, United States, 97219 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Rhode Island | |
| GSK Investigational Site | |
| Providence, Rhode Island, United States, 2906 | |
| United States, Texas | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77027 | |
| GSK Investigational Site | |
| Austin, Texas, United States, 78705 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77004 | |
| GSK Investigational Site | |
| Fort Worth, Texas, United States, 76104 | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75204 | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75246 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77030 | |
| GSK Investigational Site | |
| Galveston, Texas, United States, 77555 | |
| GSK Investigational Site | |
| El Paso, Texas, United States, 79925 | |
| GSK Investigational Site | |
| Longview, Texas, United States, 75605 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Lynchburg, Virginia, United States, 24501 | |
| GSK Investigational Site | |
| Annandale, Virginia, United States, 22003 | |
| GSK Investigational Site | |
| Norfolk, Virginia, United States, 23507 | |
| GSK Investigational Site | |
| Hampton, Virginia, United States, 23666 | |
| Canada, Ontario | |
| GSK Investigational Site | |
| Toronto, Ontario, Canada, M5G 2N2 | |
| GSK Investigational Site | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| GSK Investigational Site | |
| Toronto, Ontario, Canada, M5B 1L6 | |
| Canada, Quebec | |
| GSK Investigational Site | |
| Montreal, Quebec, Canada, H2L 4P9 | |
| GSK Investigational Site | |
| Montreal, Quebec, Canada, H2L 5B1 | |
| GSK Investigational Site | |
| Montreal, Quebec, Canada, H2X 2P4 | |
| Puerto Rico | |
| GSK Investigational Site | |
| Ponce, Puerto Rico, 00717 | |
| GSK Investigational Site | |
| Ponce, Puerto Rico, 00731 | |
| GSK Investigational Site | |
| San Juan, Puerto Rico, 00910 | |
| GSK Investigational Site | |
| San Juan, Puerto Rico, 00909-1711 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | EPZ108859, ARIES study |
| Study First Received: | February 23, 2007 |
| Last Updated: | December 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00440947 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
|
ARIES Antiretroviral-naive HIV EPZICOM |
REYATAZ NORVIR simplification |
|
Anti-Infective Agents Communicable Diseases 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 Retroviridae Infections Nucleic Acid Synthesis Inhibitors |