A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-based HAART Regimens in HIV-infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-containing HAART Regimen

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00135395
First received: August 25, 2005
Last updated: February 3, 2010
Last verified: July 2008

August 25, 2005
February 3, 2010
May 2004
February 2006   (final data collection date for primary outcome measure)
Co-Primary Outcomes in this study 1)Viral load reduction from baseline through Week 24 2)Change in lipids from baseline at Week 12
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Complete list of historical versions of study NCT00135395 on ClinicalTrials.gov Archive Site
Viral load reduction from baseline at Weeks 48,72,96;Subjects with HIV RNA<50 and <400 c/mL at Weeks 24,48,72 & 96;Patterns of resistance;Safety and tolerability through Week 96 including fasting lipid values;Adherence at Weeks 4,12,24,48,72 & 96.
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A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-based HAART Regimens in HIV-infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-containing HAART Regimen
A Phase IIIb, Open -Label, Randomized Multi-center Study Comparing the Antiviral Efficacy, Safety, and Effect on Serum Lipids of Atazanavir/Ritonavir Versus Lopinavir/Ritonavir, in Combination With Two Nucleoside or Nucleotide Reverse Transcriptase Inhibitors (NRTIs) in HIV-1 Infected Subjects Experiencing Their First Virologic Failure While Receiving a NNRTI-containing HAART Regimen.

The purpose of this study is to compare the anti-HIV efficacy, safety and effect of serum lipids of two boosted protease inhibitor-based HAART regimens (ARV/RTV v. LPV/RTV) in HIV-1 infected subjects who have experienced their first virologic failure while receiving a NNRTI-containing HAART regimen.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Atazanavir+ritonavir
    Capsules, Oral, 300mg/100mg, once daily, 24 weeks.
    Other Name: Reyataz
  • Drug: Lopinavir+ritonavir
    Capsules, Oral, 800mg/200mg, twice daily, 24 weeks.
  • Active Comparator: A
    Intervention: Drug: Atazanavir+ritonavir
  • Active Comparator: B
    Intervention: Drug: Lopinavir+ritonavir
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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
February 2006
February 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients ≥ 18 years of age infected with HIV
  • Plasma HIV RNA ≥ 1000 copies/mL and CD4 cell count ≥ 50 cells/mm3
  • Currently receiving a NNRTI-containing HAART regimen or not currently receiving a NNRTI-containing HAART regimen and have not been treated with an alternative regimen since the documented virologic failure (with genotype performed within 2 weeks of the discontinuation of the failing regimen and the genotype report is available)
  • The failing NNRTI-containing regimen must be the patient's first virologic failure on treatment and contain a NNRTI and at least 2 NRTIs. The regimen must have been administered for at least 24 weeks and the patient must have documented virologic response to the regimen (HIV RNA < 400 c/mL)

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Reported virologic failure to two or more antiretroviral regimens
  • Active AIDS-defined opportunistic infection or disease
  • Proven or suspected acute hepatitis within 30 days prior to study entry
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00135395
AI424-103
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2008

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