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Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00028301
First received: December 20, 2001
Last updated: September 10, 2010
Last verified: September 2010

December 20, 2001
September 10, 2010
February 2001
September 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00028301 on ClinicalTrials.gov Archive Site
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Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)
A Randomized Open-label Study of the Antiviral Efficacy and Safety of Atazanavir Versus Lopinavir/Ritonavir(LPV/RTV), Each in Combination With Two Nucleosides in Subjects Who Have Experienced Virologic Failure With Prior Protease Inhibitor-Containing HAART Regimen(s)

This study will compare 2 treatments in the way they affect cholesterol levels and the amount of HIV in the blood.

The study is designed to determine the metabolic changes, antiviral activity, safety, and tolerability of atazanavir as compared to LPV/RTV, each in combination with 2 nucleosides, over the initial 24 weeks, with a final analysis at 48 weeks.

Interventional
Phase 3
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Atazanavir
  • 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
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September 2003
September 2003   (final data collection date for primary outcome measure)

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are receiving a PI-containing highly active antiretroviral therapy (HAART) for at least 12 weeks.
  • Have a viral load of 1,000 or more copies/ml within 4 weeks of screening and within 4 weeks prior to randomization.
  • Have 2 CD4 cell counts of 50 or more cells/mm3 at least 96 hours apart and within 4 weeks before randomization.
  • Are at least 16 years old.
  • Have a documented virologic response to at least 1 HAART regimen.
  • Have phenotypic sensitivity to at least 2 of the following: ddl, d4T, ZDV, 3TC, ABC.
  • Have phenotypic sensitivity to atazanavir and LPV/RTV.
  • Use effective barrier methods of birth control.
  • Will be available for 48 weeks.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have taken 2 or more PIs and had virologic failure.
  • Have taken atazanavir or LPV/RTV.
  • Have an HIV-related infection (within 30 days) or any medical condition requiring treatment at the time of enrollment.
  • Have had acute hepatitis in the 30 days prior to study entry.
  • Have received certain drugs within 3 months of study start or expect to need them at time of enrollment.
  • Abuse alcohol or drugs in a way that would interfere with the study.
  • Have very bad diarrhea within 30 days prior to study entry.
  • Are pregnant or breast-feeding.
  • Have a history of hemophilia.
  • Use lipid-lowering drugs (within the previous 30 days).
  • Have cardiomyopathy or symptoms of other heart disease.
  • Cannot take medicine by mouth.
  • Have any other condition that would interfere with the study.
  • Have pancreatitis, if choosing ddI as part of NRTI pair.
  • Have bilateral peripheral neuropathy at time of screening, if choosing ddI or or d4T as part of the NRTI pair.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   Chile,   Finland,   France,   Italy,   Mexico,   Netherlands,   Peru,   Poland,   Puerto Rico,   Spain,   United Kingdom
 
NCT00028301
302D, AI424-043
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Bristol-Myers Squibb
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Bristol-Myers Squibb
September 2010

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