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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)

  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

  Show 84 Study Locations
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

No publications provided

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
Health Authority: United States: Institutional Review Board

Keywords provided by Bristol-Myers Squibb:
HIV/AIDS
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 21, 2013