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

Tracking Information
First Received Date ^ICMJE	December 20, 2001
Last Updated Date	March 24, 2009
Start Date ^ICMJE	February 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00028301 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)
Official Title ^ICMJE	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)
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 ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Open Label, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Atazanavir Drug: Lopinavir/Ritonavir
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Finland, France, Italy, Mexico, Netherlands, Peru, Poland, Puerto Rico, Spain, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00028301
Responsible Party
Study ID Numbers ^ICMJE	302D, AI424-043
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Bristol-Myers Squibb
Verification Date	October 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP