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A Study of Prevalence of the ...

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

Last Updated: 2011-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-09-30

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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A

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Phoenix, Arizona, United States

Site Status

Vista Medical Partners

Beverly Hills, California, United States

Site Status

AIDS Healthcare Foundation

Beverly Hills, California, United States

Site Status

AltaMed Health Services Corporation

Los Angeles, California, United States

Site Status

Kaiser Permanente

Los Angeles, California, United States

Site Status

Synergy Hematology and Oncology Medical Associates

Los Angeles, California, United States

Site Status

Orange Coast Medical Group

Newport Beach, California, United States

Site Status

Alameda County Medical Center

Oakland, California, United States

Site Status

East Bay AIDS Center

Oakland, California, United States

Site Status

Desert Medical Group

Palm Springs, California, United States

Site Status

Martin M. Mass, MD

San Francisco, California, United States

Site Status

Wellspring Medical Group

San Francisco, California, United States

Site Status

San Mateo Medical Center

San Mateo, California, United States

Site Status

Stanford University Medical Center

Stanford, California, United States

Site Status

Denver Public Health

Denver, Colorado, United States

Site Status

Local Institution

Denver, Colorado, United States

Site Status

Dupont Circle Physicians Group, P.C.

Washington D.C., District of Columbia, United States

Site Status

South Florida Clinical Research

Atlantis, Florida, United States

Site Status

Daniel A. Warner, MD, PA

Daytona Beach, Florida, United States

Site Status

Gary J. Richmond, MD, PA

Fort Lauderdale, Florida, United States

Site Status

Biogenomx Research Institute, LLC/CHC1-AP

Hollywood, Florida, United States

Site Status

AIDS Healthcare Foundation

Jacksonville, Florida, United States

Site Status

Steinhart Medical Associates

Miami, Florida, United States

Site Status

University of Miami School of Medicine

Miami, Florida, United States

Site Status

Care Resource, Inc.

Miami, Florida, United States

Site Status

Albert Canas MD, PA

Miami Beach, Florida, United States

Site Status

Associates in Infectious Diseases

Port Saint Lucie, Florida, United States

Site Status

Health Positive

Safety Harbor, Florida, United States

Site Status

Bach & Godofsky, MD, PA

Sarasota, Florida, United States

Site Status