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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00135447
Recruitment Status : Completed
First Posted : August 26, 2005
Last Update Posted : April 14, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease
HIV Infections

Study Design

Study Type : Observational
Estimated Enrollment : 5000 participants
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)
Study Start Date : September 2004
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
A


Outcome Measures

Biospecimen Retention:   Samples Without DNA
Serum

Eligibility Criteria

Information from the National Library of Medicine

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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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135447


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

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00135447     History of Changes
Other Study ID Numbers: AI424-128
First Posted: August 26, 2005    Key Record Dates
Last Update Posted: April 14, 2011
Last Verified: April 2011

Keywords provided by Bristol-Myers Squibb:
HIV/AIDS
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