Clinical trial NCT00135447: A Study of Prevalence of the I50L Mutation When ATV Treated Patients Fail the Regimen
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV/AIDS
Treatment Experienced
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-08-26
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: HIV infected patients failing HAART regimen

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Local Institution
state: Arizona
city: Beverly Hills
country: United States
facility: Vista Medical Partners
state: California
city: Beverly Hills
country: United States
facility: AIDS Healthcare Foundation
state: California
city: Los Angeles
country: United States
facility: AltaMed Health Services Corporation
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: Los Angeles
country: United States
facility: Synergy Hematology and Oncology Medical Associates
state: California
city: Newport Beach
country: United States
facility: Orange Coast Medical Group
state: California
city: Oakland
country: United States
facility: Alameda County Medical Center
state: California
city: Oakland
country: United States
facility: East Bay AIDS Center
state: California
city: Palm Springs
country: United States
facility: Desert Medical Group
state: California
city: San Francisco
country: United States
facility: Martin M. Mass, MD
state: California
city: San Francisco
country: United States
facility: Wellspring Medical Group
state: California
city: San Mateo
country: United States
facility: San Mateo Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Denver
country: United States
facility: Denver Public Health
state: Colorado
city: Denver
country: United States
facility: Local Institution
state: Colorado
city: Washington
country: United States
facility: Dupont Circle Physicians Group, P.C.
state: District of Columbia
city: Atlantis
country: United States
facility: South Florida Clinical Research
state: Florida
city: Daytona Beach
country: United States
facility: Daniel A. Warner, MD, PA
state: Florida
city: Fort Lauderdale
country: United States
facility: Gary J. Richmond, MD, PA
state: Florida
city: Hollywood
country: United States
facility: Biogenomx Research Institute, LLC/CHC1-AP
state: Florida
city: Jacksonville
country: United States
facility: AIDS Healthcare Foundation
state: Florida
city: Miami Beach
country: United States
facility: Albert Canas MD, PA
state: Florida
city: Miami
country: United States
facility: Steinhart Medical Associates
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Miami
country: United States
facility: Care Resource, Inc.
state: Florida
city: Port St. Lucie
country: United States
facility: Associates in Infectious Diseases
state: Florida
city: Safety Harbor
country: United States
facility: Health Positive
state: Florida
city: Sarasota
country: United States
facility: Bach & Godofsky, MD, PA
state: Florida
city: Tampa
country: United States
facility: Edward W. Braun, MD PA
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Grady Ponce de Leon Infectious Disease Clinic
state: Georgia
city: Atlanta
country: United States
facility: Atlanta ID Group
state: Georgia
city: Atlanta
country: United States
facility: Infectious Disease Solutions
state: Georgia
city: Atlanta
country: United States
facility: Infectious Disease Group of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Family Healthcare of Atlanta, PC
state: Georgia
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Riverdale
country: United States
facility: Investious Diseases Associates
state: Georgia
city: Springfield
country: United States
facility: Southern Illinois University of Medicine
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Healthcare
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Baltimore
country: United States
facility: Chase Brexton Health Services
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland, Institute of Human Virology
state: Maryland
city: Baltimore
country: United States
facility: St. Agnes Health Care, Inc.
state: Maryland
city: Prince Frederick
country: United States
facility: Calvert Internal Medicine Group
state: Maryland
city: Boston
country: United States
facility: Tufts New England Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Fenway Community Health
state: Massachusetts
city: Springfield
country: United States
facility: The Research Institute
state: Massachusetts
city: Berkley
country: United States
facility: Be Well Medical Center
state: Michigan
city: Lansing
country: United States
facility: Michaigan State Adult Medicine Clinic
state: Michigan
city: Ypsilanti
country: United States
facility: Charles P. Craig, M.D., P.C.
state: Michigan
city: St. Louis
country: United States
facility: Central West Clinical Research, Inc.
state: Missouri
city: Voorhees
country: United States
facility: Garden State Infectious Disease Associates
state: New Jersey
city: Cornwall
country: United States
facility: Philip S. Smith, MD
state: New York
city: Elmhurst
country: United States
facility: Elmhurst Hospital Center
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: Ricky K. Hsu, MD, PC
state: New York
city: New York
country: United States
facility: Ronald Grossman, MD
state: New York
city: New York
country: United States
facility: AIDS Community Research Initiative of America
state: New York
city: New York
country: United States
facility: James Jones, MD
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Local Institution
state: North Carolina
city: Hickory
country: United States
facility: Fairgrove Primary Health
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Metro Heath Medical Center
state: Ohio
city: Toledo
country: United States
facility: The University of Toledo
state: Ohio
city: Portland
country: United States
facility: The Research and Education Group
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente Northwest Region
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Columbia
country: United States
facility: Univeristy Speciality Clinics
state: South Carolina
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Dallas
country: United States
facility: Nicholaos C. Bellos, MD
state: Texas
city: Dallas
country: United States
facility: Amelia Court HIV Research
state: Texas
city: El Paso
country: United States
facility: Planned Parenthood Center of El Paso
state: Texas
city: Fort Worth
country: United States
facility: Tarrant Country Infectious Disease Associates
state: Texas
city: Harlingen
country: United States
facility: Valley AIDS Council
state: Texas
city: Houston
country: United States
facility: Therapeutic Concepts, P.A.
state: Texas
city: Houston
country: United States
facility: Diversified Medical Pratices, PA
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Lynchburg
country: United States
facility: Medical Associates of Central Virginia
state: Virginia
city: Richmond
country: United States
facility: Richmond AIDS Consortium
state: Virginia
city: Spokane
country: United States
facility: Daniel R. Coulston, MD
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: