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

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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.

Study NCT00028301. Last updated on October 1, 2007. Information provided by Bristol-Myers Squibb

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)
Official Title ^†	ARandomizedOpen-labelStudyoftheAntiviralEfficacyand SafetyofAtazanavirVersusLopinavir/Ritonavir(LPV/RTV), EachinCombinationwithTwoNucleosidesinSubjectsWho HaveExperiencedVirologicFailurewithPriorProteaseInhibitor-ContainingHAARTRegimen(s)
Brief Summary	This study will compare 2 treatments in the way they affect cholesterol levels and the amount of HIV in the blood.
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.
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Open Label, Safety Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	HIV Infections
Intervention ^†	Drug: Atazanavir Drug: Lopinavir/Ritonavir
MEDLINE PMIDs
Links	BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†
Start Date ^†	February 2001
Completion Date
Eligibility 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.
Gender	Both
Ages	16 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Finland, France, Italy, Mexico, Netherlands, Peru, Poland, Puerto Rico, Spain, United Kingdom

Administrative Information Fields
NCT ID ^†	NCT00028301
Organization ID	302D
Secondary IDs ^††	AI424-043
Study Sponsor ^†	Bristol-Myers Squibb
Collaborators ^††
Investigators ^†
Information Provided By	Bristol-Myers Squibb
Verification Date	October 2007
First Received Date ^†	December 20, 2001
Last Updated Date	October 1, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.