A Study of Prevalence of the I50L Mutation When ATV Treated Patients Fail the Regimen
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00135447 |
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Recruitment Status :
Completed
First Posted : August 26, 2005
Last Update Posted : April 14, 2011
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Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
- Study Details
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Brief Summary:
The purpose of this study is to find out the frequency of the I50L substitution among patients experiencing treatment failure on an atazanavir-containing regimen.
| Condition or disease |
|---|
| HIV Infections |
| Study Type : | Observational |
| Estimated Enrollment : | 5000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Official Title: | A Phase IV, Multicenter, Cross-sectional Study to Evaluate the I50L Substitution Among Subjects Experiencing Virologic Failure on a HAART Regimen Containing Atazanavir (ATV) |
| Study Start Date : | September 2004 |
| Actual Primary Completion Date : | September 2009 |
| Actual Study Completion Date : | September 2009 |
| Group/Cohort |
|---|
| A |
Biospecimen Retention: Samples Without DNA
Serum
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
HIV infected patients failing HAART regimen
Criteria
Inclusion Criteria:
- Atazanavir - containing antiretroviral regimen
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Confirmed virologic failure defined as either:
- HIV RNA by PCR greater than or equal to 1000 copies/mL after achieving a value of <400 copies/mL on at least 2 consecutive measurements or
- HIV RNA greater than or equal to 1000 copies/mL after 24 weeks of continuous therapy
- At least 18 years old
Exclusion Criteria:
- Unable to give informed consent
- Prisoners or subjects involuntarily incarcerated for treatment of psychiatric or physical illness
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135447
Hide Study Locations
Locations
| United States, Arizona | |
| Local Institution | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| Vista Medical Partners | |
| Beverly Hills, California, United States, 90210 | |
| AIDS Healthcare Foundation | |
| Beverly Hills, California, United States, 90211 | |
| AltaMed Health Services Corporation | |
| Los Angeles, California, United States, 90022 | |
| Kaiser Permanente | |
| Los Angeles, California, United States, 90027 | |
| Synergy Hematology and Oncology Medical Associates | |
| Los Angeles, California, United States, 90036 | |
| Orange Coast Medical Group | |
| Newport Beach, California, United States, 92663 | |
| Alameda County Medical Center | |
| Oakland, California, United States, 94602 | |
| East Bay AIDS Center | |
| Oakland, California, United States, 94609 | |
| Desert Medical Group | |
| Palm Springs, California, United States, 92262 | |
| Martin M. Mass, MD | |
| San Francisco, California, United States, 94114 | |
| Wellspring Medical Group | |
| San Francisco, California, United States, 94114 | |
| San Mateo Medical Center | |
| San Mateo, California, United States, 94403 | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| Denver Public Health | |
| Denver, Colorado, United States, 80204 | |
| Local Institution | |
| Denver, Colorado, United States, 80262 | |
| United States, District of Columbia | |
| Dupont Circle Physicians Group, P.C. | |
| Washington, District of Columbia, United States, 20009 | |
| United States, Florida | |
| South Florida Clinical Research | |
| Atlantis, Florida, United States, 33462 | |
| Daniel A. Warner, MD, PA | |
| Daytona Beach, Florida, United States, 32117 | |
| Gary J. Richmond, MD, PA | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Biogenomx Research Institute, LLC/CHC1-AP | |
| Hollywood, Florida, United States, 33020 | |
| AIDS Healthcare Foundation | |
| Jacksonville, Florida, United States, 32204 | |
| Albert Canas MD, PA | |
| Miami Beach, Florida, United States, 33140 | |
| Steinhart Medical Associates | |
| Miami, Florida, United States, 33133 | |
| University of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| Care Resource, Inc. | |
| Miami, Florida, United States, 33137 | |
| Associates in Infectious Diseases | |
| Port St. Lucie, Florida, United States, 34952 | |
| Health Positive | |
| Safety Harbor, Florida, United States, 34695 | |
| Bach & Godofsky, MD, PA | |
| Sarasota, Florida, United States, 34243 | |
| Edward W. Braun, MD PA | |
| Tampa, Florida, United States, 33614 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30308 | |
| Grady Ponce de Leon Infectious Disease Clinic | |
| Atlanta, Georgia, United States, 30308 | |
| Atlanta ID Group | |
| Atlanta, Georgia, United States, 30309 | |
| Infectious Disease Solutions | |
| Atlanta, Georgia, United States, 30309 | |
| Infectious Disease Group of Atlanta | |
| Atlanta, Georgia, United States, 30312 | |
| Family Healthcare of Atlanta, PC | |
| Atlanta, Georgia, United States, 30318 | |
| Atlanta VA Medical Center | |
| Decatur, Georgia, United States, 30033 | |
| Investious Diseases Associates | |
| Riverdale, Georgia, United States, 30274 | |
| United States, Illinois | |
| Southern Illinois University of Medicine | |
| Springfield, Illinois, United States, 62702 | |
| United States, Iowa | |
| University of Iowa Healthcare | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kentucky | |
| University of Kentucky Medical Center | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Maryland | |
| Chase Brexton Health Services | |
| Baltimore, Maryland, United States, 21201 | |
| University of Maryland, Institute of Human Virology | |
| Baltimore, Maryland, United States, 21201 | |
| St. Agnes Health Care, Inc. | |
| Baltimore, Maryland, United States, 21229 | |
| Calvert Internal Medicine Group | |
| Prince Frederick, Maryland, United States, 20678 | |
| United States, Massachusetts | |
| Tufts New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| Fenway Community Health | |
| Boston, Massachusetts, United States, 02115 | |
| The Research Institute | |
| Springfield, Massachusetts, United States, 01107 | |
| United States, Michigan | |
| Be Well Medical Center | |
| Berkley, Michigan, United States, 48072 | |
| Michaigan State Adult Medicine Clinic | |
| Lansing, Michigan, United States, 48910 | |
| Charles P. Craig, M.D., P.C. | |
| Ypsilanti, Michigan, United States, 48197 | |
| United States, Missouri | |
| Central West Clinical Research, Inc. | |
| St. Louis, Missouri, United States, 63108 | |
| United States, New Jersey | |
| Garden State Infectious Disease Associates | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New York | |
| Philip S. Smith, MD | |
| Cornwall, New York, United States, 12518 | |
| Elmhurst Hospital Center | |
| Elmhurst, New York, United States, 11373 | |
| Beth Israel Medical Center | |
| New York, New York, United States, 10003 | |
| Ricky K. Hsu, MD, PC | |
| New York, New York, United States, 10011 | |
| Ronald Grossman, MD | |
| New York, New York, United States, 10016 | |
| AIDS Community Research Initiative of America | |
| New York, New York, United States, 10018 | |
| James Jones, MD | |
| New York, New York, United States, 11019 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Local Institution | |
| Charlotte, North Carolina, United States, 28209 | |
| Fairgrove Primary Health | |
| Hickory, North Carolina, United States, 28602 | |
| United States, Ohio | |
| University of Cincinnati Medical Center | |
| Cincinnati, Ohio, United States, 45267 | |
| Metro Heath Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| The University of Toledo | |
| Toledo, Ohio, United States, 43614 | |
| United States, Oregon | |
| The Research and Education Group | |
| Portland, Oregon, United States, 97209 | |
| Kaiser Permanente Northwest Region | |
| Portland, Oregon, United States, 97227 | |
| United States, Pennsylvania | |
| Lehigh Valley Hospital | |
| Allentown, Pennsylvania, United States, 18102 | |
| United States, South Carolina | |
| Univeristy Speciality Clinics | |
| Columbia, South Carolina, United States, 29203 | |
| Greenville Hospital System | |
| Greenville, South Carolina, United States, 29605 | |
| United States, Texas | |
| Nicholaos C. Bellos, MD | |
| Dallas, Texas, United States, 75204 | |
| Amelia Court HIV Research | |
| Dallas, Texas, United States, 75235 | |
| Planned Parenthood Center of El Paso | |
| El Paso, Texas, United States, 79903 | |
| Tarrant Country Infectious Disease Associates | |
| Fort Worth, Texas, United States, 76104 | |
| Valley AIDS Council | |
| Harlingen, Texas, United States, 78550 | |
| Therapeutic Concepts, P.A. | |
| Houston, Texas, United States, 77004 | |
| Diversified Medical Pratices, PA | |
| Houston, Texas, United States, 77027 | |
| United States, Virginia | |
| University of Virginia Health System | |
| Charlottesville, Virginia, United States, 22908 | |
| Medical Associates of Central Virginia | |
| Lynchburg, Virginia, United States, 24501 | |
| Richmond AIDS Consortium | |
| Richmond, Virginia, United States, 23219 | |
| United States, Washington | |
| Daniel R. Coulston, MD | |
| Spokane, Washington, United States, 99204 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00135447 History of Changes |
| Other Study ID Numbers: |
AI424-128 |
| First Posted: | August 26, 2005 Key Record Dates |
| Last Update Posted: | April 14, 2011 |
| Last Verified: | April 2011 |
Keywords provided by Bristol-Myers Squibb:
|
HIV/AIDS Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |