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

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: August 25, 2005
Last updated: April 13, 2011
Last verified: April 2011
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.

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:

Further study details as provided by Bristol-Myers Squibb:

Biospecimen Retention:   Samples Without DNA

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)


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

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 identifier: NCT00135447

  Show 84 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb 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:
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 processed this record on September 19, 2017