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

Sponsor:	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

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Masking: 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)

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Cholesterol HIV/AIDS HIV/AIDS Medicines

Drug Information available for: Ritonavir Lopinavir BMS 232632 Atazanavir sulfate

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Study Start Date:	February 2001
Study Completion Date:	September 2003
Primary Completion Date:	September 2003 (Final data collection date for primary outcome measure)

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

Additional 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

No publications provided

ClinicalTrials.gov Identifier:	NCT00028301 History of Changes
Other Study ID Numbers:	302D, AI424-043
Study First Received:	December 20, 2001
Last Updated:	September 10, 2010
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

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protease Inhibitors
Ritonavir

Lopinavir
Atazanavir
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012