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

August 25, 2005
April 13, 2011
September 2004
September 2009   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00135447 on ClinicalTrials.gov Archive Site
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A Study of Prevalence of the I50L Mutation When ATV Treated Patients Fail the Regimen
A Phase IV, Multicenter, Cross-sectional Study to Evaluate the I50L Substitution Among Subjects Experiencing Virologic Failure on a HAART Regimen Containing Atazanavir (ATV)

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

Serum

Probability Sample

HIV infected patients failing HAART regimen

HIV Infections
Not Provided
A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5000
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00135447
AI424-128
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP