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

This study is currently recruiting participants.

Verified by Bristol-Myers Squibb, January 2009

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00135447

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

MedlinePlus related topics: AIDS

Drug Information available for: Atazanavir sulfate BMS 232632

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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)

Further study details as provided by Bristol-Myers Squibb:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Serum

Estimated Enrollment:	5000
Study Start Date:	September 2004
Estimated Study Completion Date:	September 2009
Estimated 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
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135447

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 118 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More 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:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	AI424-128
Study First Received:	August 25, 2005
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00135447
Health Authority:	United States: Institutional Review Board

Keywords provided by Bristol-Myers Squibb:

HIV/AIDS
Treatment Experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Atazanavir
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009