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

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00135447

First received: August 25, 2005

Last updated: April 13, 2011

Last verified: April 2011

History of Changes

Purpose

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
HIV Infections


Study Type:	Observational
Study Design:	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)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Biospecimen Retention: Samples Without DNA

Serum


Estimated Enrollment:	5000
Study Start Date:	September 2004
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
A

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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
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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site


Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00135447 History of Changes
Other Study ID Numbers:	AI424-128
Study First Received:	August 25, 2005
Last Updated:	April 13, 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

ClinicalTrials.gov processed this record on May 25, 2017

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