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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00096746
First Posted: November 16, 2004
Last Update Posted: April 13, 2011
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.
Information provided by:
Bristol-Myers Squibb
November 15, 2004
November 16, 2004
April 13, 2011
November 2004
September 2006   (Final data collection date for primary outcome measure)
The log10 HIV RNA change from baseline for each cohort. [ Time Frame: through Week 48 ]
Not Provided
Complete list of historical versions of study NCT00096746 on ClinicalTrials.gov Archive Site
Evaluate proportion of patients with plasma HIV RNA <50 copies/mL [ Time Frame: at Weeks 24, 48, 72, and 96. ]
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Effect of the Atazanavir (ATV) 150L Mutation on Subsequent Treatment Response in HIV Infected Subjects
An Exploratory Study of the Effect of the Atazanavir (ATV) I50L Mutation on Subsequent Treatment Response
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
HIV infected individuals on first line ATV based HAART with presence of I50L mutation & HIV infected PI naïve on failed NNRTI based regimen.
HIV Infection
Drug: LPV/RTV + 2NRTIs
Tablets, Oral, Variable, Twice daily, 48 weeks.
  • A1
    HIV infected individuals on first line ATV based HAART with presence of I50L mutation.
    Intervention: Drug: LPV/RTV + 2NRTIs
  • A2
    HIV infected PI naïve on failed NNRTI based regimen.
    Intervention: Drug: LPV/RTV + 2NRTIs
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
September 2006
September 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Guatemala,   Mexico,   Peru,   South Africa,   United States
Chile,   Puerto Rico
 
NCT00096746
AI424-079
No
Not Provided
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Bristol-Myers Squibb
Not Provided
Study Chair: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2011
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