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Effect of the Atazanavir (ATV) 150L Mutation on Subsequent Treatment Response in HIV Infected Subjects

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: November 15, 2004
Last updated: April 12, 2011
Last verified: April 2011
This study will compare the response of subjects who failed a first-line ATV-containing regimen and who have the 150L-containing virus to subsequent protease inhibitor (PI)-containing therapy with that of a cohort who has failed a first-line reverse transcriptase inhibitor (NNRTI), and is subsequently receiving PI-containing therapy.

Condition Intervention
HIV Infection
Drug: LPV/RTV + 2NRTIs

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Exploratory Study of the Effect of the Atazanavir (ATV) I50L Mutation on Subsequent Treatment Response

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The log10 HIV RNA change from baseline for each cohort. [ Time Frame: through Week 48 ]

Secondary Outcome Measures:
  • Evaluate proportion of patients with plasma HIV RNA <50 copies/mL [ Time Frame: at Weeks 24, 48, 72, and 96. ]

Estimated Enrollment: 200
Study Start Date: November 2004
Estimated Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HIV infected individuals on first line ATV based HAART with presence of I50L mutation.
Drug: LPV/RTV + 2NRTIs
Tablets, Oral, Variable, Twice daily, 48 weeks.
HIV infected PI naïve on failed NNRTI based regimen.
Drug: LPV/RTV + 2NRTIs
Tablets, Oral, Variable, Twice daily, 48 weeks.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV infected individuals on first line ATV based HAART with presence of I50L mutation & HIV infected PI naïve on failed NNRTI based regimen.

Inclusion Criteria:

  • Currently on a first-line antiretroviral regimen containing ATV with a confirmed rebound and a genotype that verifies the presence of an 150L mutation OR on a first-line regimen containing an NNRTI and PI-naive, with a confirmed rebound

Exclusion Criteria:

  • Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
  • Women who are pregnant or breastfeeding.
  • A life expectancy of <12 months.
  • Presence of a newly diagnosed HIV-related opportunistic infection or any other medical condition requiring acute therapy at the time of enrollment.
  • Active alcohol or substance abuse sufficient, in the investigator's opinion, to prevent adequate adherence to study therapy or to increase the risk of developing pancreatitis or chemical hepatitis.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00096746

  Show 36 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Study Chair: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information: Identifier: NCT00096746     History of Changes
Other Study ID Numbers: AI424-079
Study First Received: November 15, 2004
Last Updated: April 12, 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
Atazanavir Sulfate
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents processed this record on May 23, 2017