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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00028067 |
Purpose
The purpose of this study is to compare the atazanavir and nelfinavir (NFV) treatments in their ability to reduce viral load.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Atazanavir Drug: Nelfinavir mesylate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Active Control, Safety/Efficacy Study |
| Official Title: | A Phase III Study Comparing the Antiviral Efficacy and Safety of Atazanavir With Nelfinavir: Each in Combination With Dual Nucleoside Therapy in HIV-Infected Subjects Who Have Failed a Regimen Not Containing a Protease Inhibitor |
| Estimated Enrollment: | 500 |
| Study Start Date: | August 2001 |
In this double-blind, double-placebo, randomized, 2-arm study, atazanavir and NFV each are given in combination with 2 open-label nucleoside reverse transcriptase inhibitors (NRTIs) over 48 weeks. Patients assigned to atazanavir will receive placebo capsules which are identical in size and appearance to NFV. Patients assigned to NFV will receive placebo capsules which are identical in size and appearance to atazanavir. HIV levels are monitored.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients may not be eligible for this study if they:
Contacts and Locations
Hide Study Locations| United States, Arkansas | |
| Health for Life Clinic | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Kaiser Foundation Hospital | |
| San Francisco, California, United States, 94118 | |
| HIV Institute / Davies Med Ctr | |
| San Francisco, California, United States, 94114 | |
| Kaiser Hospital | |
| Sacramento, California, United States, 95825 | |
| East Bay AIDS Ctr | |
| Berkeley, California, United States, 94705 | |
| Orange County Ctr for Special Immunology | |
| Fountain Valley, California, United States, 92708 | |
| Tower Infectious Diseases | |
| Los Angeles, California, United States, 90048 | |
| United States, Florida | |
| Larry Bush | |
| Atlantis, Florida, United States, 33462 | |
| Bach and Godofsky | |
| Bradenton, Florida, United States, 34205 | |
| Daniel Seekins | |
| Tampa, Florida, United States, 33607 | |
| Infectious Diseases Associates | |
| Sarasota, Florida, United States, 34239 | |
| North Broward Hosp District / HIV Clinical Research | |
| Fort Lauderdale, Florida, United States, 33311 | |
| Infectious Disease Research Inst | |
| Tampa, Florida, United States, 33614 | |
| IDC Research Initiative | |
| Altamonte Springs, Florida, United States, 32701 | |
| Gary Richmond MD | |
| Fort Lauderdale, Florida, United States, 33316 | |
| United States, Georgia | |
| Med College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| Philip Brachman | |
| Atlanta, Georgia, United States, 30309 | |
| United States, Illinois | |
| Cook County Gen Hosp / Division of Infect Diseases | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Division of Inf Diseases/ Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| Tulane Univ School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| Community Research Initiative of New England | |
| Brookline, Massachusetts, United States, 02445 | |
| Beth Israel Deaconess Med Ctr | |
| Boston, Massachusetts, United States, 02215 | |
| CRI - Springfield | |
| Springfield, Massachusetts, United States, 01107 | |
| United States, Michigan | |
| Henry Ford Hosp | |
| Detroit, Michigan, United States, 48202 | |
| Infectious Disease Clinic | |
| Warren, Michigan, United States, 48089 | |
| United States, Missouri | |
| Washington Univ School of Medicine | |
| St Louis, Missouri, United States, 63108 | |
| United States, New Jersey | |
| South Jersey Infectious Diseases Inc | |
| Somers Point, New Jersey, United States, 08244 | |
| United States, New York | |
| Community Research Initiative on AIDS | |
| New York, New York, United States, 10018 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| Saint Luke's - Roosevelt Hosp Ctr | |
| New York, New York, United States, 10019 | |
| Albert Einstein College of Medicine | |
| Bronx, New York, United States, 10461 | |
| United States, North Carolina | |
| Wake Forest Univ School of Medicine | |
| Winston Salem, North Carolina, United States, 27157 | |
| Carolinas Med Ctr | |
| Charlotte, North Carolina, United States, 28232 | |
| Jemsek Clinic | |
| Huntersville, North Carolina, United States, 28078 | |
| Piedmont Infectious Disease Consultants | |
| Hickory, North Carolina, United States, 28602 | |
| United States, Ohio | |
| Summa Health System | |
| Akron, Ohio, United States, 44304 | |
| United States, Oklahoma | |
| Associates in Med and Mental Health | |
| Tulsa, Oklahoma, United States, 74114 | |
| United States, Oregon | |
| Research & Education Group | |
| Portland, Oregon, United States, 97209 | |
| United States, Pennsylvania | |
| Hahnemann Univ Hosp | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| United States, South Carolina | |
| Ludwig Lettau Private Practice | |
| Charleston, South Carolina, United States, 29414 | |
| Univ of South Carolina School of Medicine | |
| Columbia, South Carolina, United States, 29203 | |
| United States, Texas | |
| Univ TX Health Science Ctr | |
| Houston, Texas, United States, 77030 | |
| Univ of Texas Southwestern Med Ctr | |
| Dallas, Texas, United States, 75390 | |
| Joseph Gathe | |
| Houston, Texas, United States, 77004 | |
| North Texas Center for AIDS & Clinical Research | |
| Dallas, Texas, United States, 75208 | |
| United States, Virginia | |
| Hampton Roads Med Specialists | |
| Hampton, Virginia, United States, 23666 | |
| United States, Wisconsin | |
| Wisconsin AIDS Research Consortium | |
| Milwaukee, Wisconsin, United States, 53203 | |
| Canada, British Columbia | |
| Downtown Infectious Diseases Clinic | |
| Vancouver, British Columbia, Canada | |
| Canada, Ontario | |
| McMaster Univ Med Ctr | |
| Hamilton, Ontario, Canada | |
| Sunnybrook Health Science Ctr | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Clinique Medicale L'Actuele | |
| Montreal, Quebec, Canada | |
| Clinique Medicale du Quartier Latin | |
| Montreal, Quebec, Canada | |
| Mexico | |
| Instituto Nacional de la Nutricion | |
| Mexico City, Mexico | |
| Instituto Nacional de Enfermedades Respiratorias | |
| Mexico City, Mexico | |
| Hospital Regional | |
| Mexico City, Mexico | |
| Hospital General De Mexico | |
| Mexico City, Mexico | |
| Puerto Rico | |
| Ponce School of Medicine | |
| Ponce, Puerto Rico, 00732 | |
| Hepatology / Infectious Diseases | |
| Santruce, Puerto Rico, 00909 | |
| Thailand | |
| Program on AIDS / Thai Red Cross Society | |
| Bangkok, Thailand | |
| Khonkaen Univ | |
| Khonkaen, Thailand | |
| Ramathibodi Hosp | |
| Bangkok, Thailand | |
| Siriraj Hosp / Mahidol Univ | |
| Bangkok, Thailand | |
| Study Director: | Michael Giordano |
More Information
| Study ID Numbers: | 302F, AI424-037 |
| Study First Received: | December 10, 2001 |
| Last Updated: | October 1, 2007 |
| ClinicalTrials.gov Identifier: | NCT00028067 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination HIV Protease Inhibitors RNA, Viral |
Reverse Transcriptase Inhibitors Viral Load BMS 232632 |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Nelfinavir Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections HIV Protease Inhibitors |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Atazanavir Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |