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

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. Identifier: NCT00028301
Recruitment Status : Completed
First Posted : December 21, 2001
Last Update Posted : September 13, 2010
Information provided by:
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Atazanavir Drug: Lopinavir/Ritonavir Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : February 2001
Actual Primary Completion Date : September 2003
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00028301

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Sponsors and Collaborators
Bristol-Myers Squibb
Layout table for additonal information Identifier: NCT00028301    
Other Study ID Numbers: 302D
First Posted: December 21, 2001    Key Record Dates
Last Update Posted: September 13, 2010
Last Verified: September 2010
Keywords provided by Bristol-Myers Squibb:
HIV Protease Inhibitors
RNA, Viral
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
ABT 378
Antiretroviral Therapy, Highly Active
Lipoproteins, LDL Cholesterol
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Atazanavir Sulfate
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors