Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
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.
Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00028301
  Purpose

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


Condition Intervention Phase
HIV Infections
Drug: Atazanavir
Drug: Lopinavir/Ritonavir
Phase III

MedlinePlus related topics: AIDS AIDS Medicines Cholesterol
Drug Information available for: Ritonavir Lopinavir Atazanavir sulfate BMS 232632 Cholest-5-en-3-ol (3beta)- Lipids
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Safety Study
Official Title: ARandomizedOpen-labelStudyoftheAntiviralEfficacyand SafetyofAtazanavirVersusLopinavir/Ritonavir(LPV/RTV), EachinCombinationwithTwoNucleosidesinSubjectsWho HaveExperiencedVirologicFailurewithPriorProteaseInhibitor-ContainingHAARTRegimen(s)

Further study details as provided by Bristol-Myers Squibb:

Study Start Date: February 2001
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028301

  Show 97 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

Study ID Numbers: 302D, AI424-043
Study First Received: December 20, 2001
Last Updated: October 1, 2007
ClinicalTrials.gov Identifier: NCT00028301  
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
HIV Protease Inhibitors
RNA, Viral
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Lipids
ABT 378
Antiretroviral Therapy, Highly Active
Lipoproteins, LDL Cholesterol

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Lopinavir
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Atazanavir
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 16, 2009