HIV Infections Clinical Trial
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)
| Verified date | April 2011 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 5000 |
| Est. completion date | September 2009 |
| Est. primary completion date | September 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Atazanavir - containing antiretroviral regimen - Confirmed virologic failure defined as either: 1. 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 2. 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 |
Observational Model: Cohort, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| United States | Lehigh Valley Hospital | Allentown | Pennsylvania |
| United States | Atlanta ID Group | Atlanta | Georgia |
| United States | Emory University | Atlanta | Georgia |
| United States | Family Healthcare of Atlanta, PC | Atlanta | Georgia |
| United States | Grady Ponce de Leon Infectious Disease Clinic | Atlanta | Georgia |
| United States | Infectious Disease Group of Atlanta | Atlanta | Georgia |
| United States | Infectious Disease Solutions | Atlanta | Georgia |
| United States | South Florida Clinical Research | Atlantis | Florida |
| United States | Chase Brexton Health Services | Baltimore | Maryland |
| United States | St. Agnes Health Care, Inc. | Baltimore | Maryland |
| United States | University of Maryland, Institute of Human Virology | Baltimore | Maryland |
| United States | Be Well Medical Center | Berkley | Michigan |
| United States | AIDS Healthcare Foundation | Beverly Hills | California |
| United States | Vista Medical Partners | Beverly Hills | California |
| United States | Fenway Community Health | Boston | Massachusetts |
| United States | Tufts New England Medical Center | Boston | Massachusetts |
| United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
| United States | Local Institution | Charlotte | North Carolina |
| United States | University of Virginia Health System | Charlottesville | Virginia |
| United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
| United States | Metro Heath Medical Center | Cleveland | Ohio |
| United States | Univeristy Speciality Clinics | Columbia | South Carolina |
| United States | Philip S. Smith, MD | Cornwall | New York |
| United States | Amelia Court HIV Research | Dallas | Texas |
| United States | Nicholaos C. Bellos, MD | Dallas | Texas |
| United States | Daniel A. Warner, MD, PA | Daytona Beach | Florida |
| United States | Atlanta VA Medical Center | Decatur | Georgia |
| United States | Denver Public Health | Denver | Colorado |
| United States | Local Institution | Denver | Colorado |
| United States | Planned Parenthood Center of El Paso | El Paso | Texas |
| United States | Elmhurst Hospital Center | Elmhurst | New York |
| United States | Gary J. Richmond, MD, PA | Fort Lauderdale | Florida |
| United States | Tarrant Country Infectious Disease Associates | Fort Worth | Texas |
| United States | Greenville Hospital System | Greenville | South Carolina |
| United States | Valley AIDS Council | Harlingen | Texas |
| United States | Fairgrove Primary Health | Hickory | North Carolina |
| United States | Biogenomx Research Institute, LLC/CHC1-AP | Hollywood | Florida |
| United States | Diversified Medical Pratices, PA | Houston | Texas |
| United States | Therapeutic Concepts, P.A. | Houston | Texas |
| United States | University of Iowa Healthcare | Iowa City | Iowa |
| United States | AIDS Healthcare Foundation | Jacksonville | Florida |
| United States | Michaigan State Adult Medicine Clinic | Lansing | Michigan |
| United States | University of Kentucky Medical Center | Lexington | Kentucky |
| United States | AltaMed Health Services Corporation | Los Angeles | California |
| United States | Kaiser Permanente | Los Angeles | California |
| United States | Synergy Hematology and Oncology Medical Associates | Los Angeles | California |
| United States | Medical Associates of Central Virginia | Lynchburg | Virginia |
| United States | Care Resource, Inc. | Miami | Florida |
| United States | Steinhart Medical Associates | Miami | Florida |
| United States | University of Miami School of Medicine | Miami | Florida |
| United States | Albert Canas MD, PA | Miami Beach | Florida |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | AIDS Community Research Initiative of America | New York | New York |
| United States | Beth Israel Medical Center | New York | New York |
| United States | James Jones, MD | New York | New York |
| United States | Ricky K. Hsu, MD, PC | New York | New York |
| United States | Ronald Grossman, MD | New York | New York |
| United States | Orange Coast Medical Group | Newport Beach | California |
| United States | Alameda County Medical Center | Oakland | California |
| United States | East Bay AIDS Center | Oakland | California |
| United States | Desert Medical Group | Palm Springs | California |
| United States | Local Institution | Phoenix | Arizona |
| United States | Associates in Infectious Diseases | Port St. Lucie | Florida |
| United States | Kaiser Permanente Northwest Region | Portland | Oregon |
| United States | The Research and Education Group | Portland | Oregon |
| United States | Calvert Internal Medicine Group | Prince Frederick | Maryland |
| United States | Richmond AIDS Consortium | Richmond | Virginia |
| United States | Investious Diseases Associates | Riverdale | Georgia |
| United States | Health Positive | Safety Harbor | Florida |
| United States | Martin M. Mass, MD | San Francisco | California |
| United States | Wellspring Medical Group | San Francisco | California |
| United States | San Mateo Medical Center | San Mateo | California |
| United States | Bach & Godofsky, MD, PA | Sarasota | Florida |
| United States | Daniel R. Coulston, MD | Spokane | Washington |
| United States | Southern Illinois University of Medicine | Springfield | Illinois |
| United States | The Research Institute | Springfield | Massachusetts |
| United States | Central West Clinical Research, Inc. | St. Louis | Missouri |
| United States | Stanford University Medical Center | Stanford | California |
| United States | Edward W. Braun, MD PA | Tampa | Florida |
| United States | The University of Toledo | Toledo | Ohio |
| United States | New York Medical College | Valhalla | New York |
| United States | Garden State Infectious Disease Associates | Voorhees | New Jersey |
| United States | Dupont Circle Physicians Group, P.C. | Washington | District of Columbia |
| United States | Charles P. Craig, M.D., P.C. | Ypsilanti | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
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