A Study of Prevalence of the I50L Mutation When ATV Treated Patients Fail the Regimen

April 13, 2011 updated by: Bristol-Myers Squibb

A Phase IV, Multicenter, Cross-sectional Study to Evaluate the I50L Substitution Among Subjects Experiencing Virologic Failure on a HAART Regimen Containing Atazanavir (ATV)

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Local Institution
    • California
      • Beverly Hills, California, United States, 90210
        • Vista Medical Partners
      • Beverly Hills, California, United States, 90211
        • AIDS Healthcare Foundation
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente
      • Los Angeles, California, United States, 90022
        • AltaMed Health Services Corporation
      • Los Angeles, California, United States, 90036
        • Synergy Hematology and Oncology Medical Associates
      • Newport Beach, California, United States, 92663
        • Orange Coast Medical Group
      • Oakland, California, United States, 94602
        • Alameda County Medical Center
      • Oakland, California, United States, 94609
        • East Bay AIDS Center
      • Palm Springs, California, United States, 92262
        • Desert Medical Group
      • San Francisco, California, United States, 94114
        • Martin M. Mass, MD
      • San Francisco, California, United States, 94114
        • Wellspring Medical Group
      • San Mateo, California, United States, 94403
        • San Mateo Medical Center
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver public Health
      • Denver, Colorado, United States, 80262
        • Local Institution
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
        • Dupont Circle Physicians Group, P.C.
    • Florida
      • Atlantis, Florida, United States, 33462
        • South Florida Clinical Research
      • Daytona Beach, Florida, United States, 32117
        • Daniel A. Warner, MD, PA
      • Fort Lauderdale, Florida, United States, 33316
        • Gary J. Richmond, MD, PA
      • Hollywood, Florida, United States, 33020
        • Biogenomx Research Institute, LLC/CHC1-AP
      • Jacksonville, Florida, United States, 32204
        • AIDS Healthcare Foundation
      • Miami, Florida, United States, 33136
        • University of Miami School of Medicine
      • Miami, Florida, United States, 33133
        • Steinhart Medical Associates
      • Miami, Florida, United States, 33137
        • Care Resource, Inc.
      • Miami Beach, Florida, United States, 33140
        • Albert Canas MD, PA
      • Port St. Lucie, Florida, United States, 34952
        • Associates in Infectious Diseases
      • Safety Harbor, Florida, United States, 34695
        • Health Positive
      • Sarasota, Florida, United States, 34243
        • Bach & Godofsky, MD, PA
      • Tampa, Florida, United States, 33614
        • Edward W. Braun, MD PA
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University
      • Atlanta, Georgia, United States, 30309
        • Atlanta ID Group
      • Atlanta, Georgia, United States, 30308
        • Grady Ponce de Leon Infectious Disease Clinic
      • Atlanta, Georgia, United States, 30309
        • Infectious Disease Solutions
      • Atlanta, Georgia, United States, 30312
        • Infectious Disease Group of Atlanta
      • Atlanta, Georgia, United States, 30318
        • Family Healthcare of Atlanta, PC
      • Decatur, Georgia, United States, 30033
        • Atlanta VA Medical Center
      • Riverdale, Georgia, United States, 30274
        • Investious Diseases Associates
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University of Medicine
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Healthcare
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Institute of Human Virology
      • Baltimore, Maryland, United States, 21201
        • Chase Brexton Health Services
      • Baltimore, Maryland, United States, 21229
        • St. Agnes Health Care, Inc.
      • Prince Frederick, Maryland, United States, 20678
        • Calvert Internal Medicine Group
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts New England Medical Center
      • Boston, Massachusetts, United States, 02115
        • Fenway Community Health
      • Springfield, Massachusetts, United States, 01107
        • The Research Institute
    • Michigan
      • Berkley, Michigan, United States, 48072
        • Be Well Medical Center
      • Lansing, Michigan, United States, 48910
        • Michaigan State Adult Medicine Clinic
      • Ypsilanti, Michigan, United States, 48197
        • Charles P. Craig, M.D., P.C.
    • Missouri
      • St. Louis, Missouri, United States, 63108
        • Central West Clinical Research, Inc.
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Garden State Infectious Disease Associates
    • New York
      • Cornwall, New York, United States, 12518
        • Philip S. Smith, MD
      • Elmhurst, New York, United States, 11373
        • Elmhurst Hospital Center
      • New York, New York, United States, 10003
        • Beth Israel Medical Center
      • New York, New York, United States, 10018
        • AIDS Community Research Initiative of America
      • New York, New York, United States, 10011
        • Ricky K. Hsu, MD, PC
      • New York, New York, United States, 10016
        • Ronald Grossman, MD
      • New York, New York, United States, 11019
        • James Jones, MD
      • Valhalla, New York, United States, 10595
        • New York Medical College
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina At Chapel Hill
      • Charlotte, North Carolina, United States, 28209
        • Local Institution
      • Hickory, North Carolina, United States, 28602
        • Fairgrove Primary Health
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, United States, 44109
        • Metro Heath Medical Center
      • Toledo, Ohio, United States, 43614
        • The University of Toledo
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Northwest Region
      • Portland, Oregon, United States, 97209
        • The Research and Education Group
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18102
        • Lehigh Valley Hospital
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Univeristy Speciality Clinics
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System
    • Texas
      • Dallas, Texas, United States, 75204
        • Nicholaos C. Bellos, MD
      • Dallas, Texas, United States, 75235
        • Amelia Court HIV Research
      • El Paso, Texas, United States, 79903
        • Planned Parenthood Center of El Paso
      • Fort Worth, Texas, United States, 76104
        • Tarrant Country Infectious Disease Associates
      • Harlingen, Texas, United States, 78550
        • Valley AIDS Council
      • Houston, Texas, United States, 77004
        • Therapeutic Concepts, P.A.
      • Houston, Texas, United States, 77027
        • Diversified Medical Pratices, PA
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System
      • Lynchburg, Virginia, United States, 24501
        • Medical Associates of Central Virginia
      • Richmond, Virginia, United States, 23219
        • Richmond AIDS Consortium
    • Washington
      • Spokane, Washington, United States, 99204
        • Daniel R. Coulston, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

HIV infected patients failing HAART regimen

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
A

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

August 25, 2005

First Submitted That Met QC Criteria

August 25, 2005

First Posted (Estimate)

August 26, 2005

Study Record Updates

Last Update Posted (Estimate)

April 14, 2011

Last Update Submitted That Met QC Criteria

April 13, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI424-128

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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