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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00096746
First received: November 15, 2004
Last updated: April 12, 2011
Last verified: April 2011

November 15, 2004
April 12, 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 ]
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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.

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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
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*   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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   United States,   South Africa,   Argentina,   Guatemala,   Mexico,   Peru
 
NCT00096746
AI424-079
No
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Bristol-Myers Squibb
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Study Chair: 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