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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00135395
First Posted: August 26, 2005
Last Update Posted: February 5, 2010
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
August 25, 2005
August 26, 2005
February 5, 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
Intervention Model: Single Group Assignment
Masking: None (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
Not Provided

*   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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00135395
AI424-103
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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