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

September 10, 2010 updated by: Bristol-Myers Squibb

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

        • Aurora hospital
        • Department of Infection & Tropical Medicine
        • Klinicka Chorobzkaznych AM
  • Argentina
      • Buenos Aires, Argentina
        • Hospital Italiano
      • Buenos Aires, Argentina
        • Fundación Huésped
      • Buenos Aires, Argentina
        • Claudia Rodriguez MD
      • Buenos Aires, Argentina
        • Elida Pallone MD
      • Rosario Santa Fe, Argentina
        • CAICI
  • Australia
      • Prahan, Australia
        • Alfred Hosp
      • South Yarra, Australia
        • Prahran Market Clinic
      • Sydney, Australia
        • Taylors Square Clinic
      • Sydney, Australia
        • Saint Vincent's Hosp Med Centre
  • Belgium
      • Antwerpe, Belgium
        • Inst of Tropical Medicine
      • Brussels, Belgium
        • CHU Saint Pierre
      • Bruxelles, Belgium
        • Cliniques Universitaires Saint Luc
      • Gent, Belgium
        • University Hospital Gent
      • Liege, Belgium
        • Domaine Universitaire Du SART-TILMAN
  • Brazil
      • Curitiba, Brazil
        • Hospital de Clínicas da Universidade Federal do Paraná
      • Porto Alegre, Brazil
        • Hospital Nossa Senhora da Conceicao-GCH
      • Sao Paulo, Brazil
        • Instituto de Infectologia Emilio Ribas
  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Toronto Hosp
    • Quebec
      • Montreal, Quebec, Canada
        • Montreal Gen Hosp / Div of Clin Immuno and Allergy
      • Montreal, Quebec, Canada
        • Clinique Medicale du Quartier Latin
      • Montreal, Quebec, Canada
        • Dr Roger P Leblanc
  • Chile
      • Santiago, Chile
        • Fundacion Arriaran
      • Santiago, Chile
        • Hosp Sotero de Rio
  • France
      • Lyon, France
        • Hopital Hotel Dieu de Lyon
      • Paris, France
        • CHU de Bicetre
      • Paris, France
        • Hopital Cochin - Port Royal
      • Paris Cedex 12, France
        • Services des Maladies Infectieuses
      • Tourcoing, France
        • Hôpital Gustave Dron
  • Italy
      • Bologna, Italy
        • Ospedale S Orsola
      • Cagliari, Italy
        • Immunoligia Universita Cagliari
      • Corso Svizzera, Italy
        • Reparto di Malattie Infettive
      • Milano, Italy
        • Ospedale Luigi Sacco Cargnel
      • Milano, Italy
        • Ospedale S Raffaele
      • Rimini, Italy
        • Ospedale degli Infermi
      • Roma, Italy
        • Cat All Immun Clin
      • Torino, Italy
        • Ospedale Amedeo di Savoia
      • Torino, Italy
        • Ospedale Amedeo de Savoia
  • Mexico
      • Mexico City, Mexico
        • Instituto Nacional de la Nutricion
      • Mexico City, Mexico
        • Hospital Regional
      • Mexico City, Mexico
        • Hospital General
      • Mexico City, Mexico
        • Hospital 1 ro de Octubre
  • Netherlands
      • CX Utrecht, Netherlands
        • Univ Medical Center Utrecht
  • Peru
      • Lima, Peru
        • Hosp Guillermo Almenara-Medicina 1
      • Lima, Peru
        • Hosp Nacional Cayetano Heredia
  • Puerto Rico
      • Coto Laurel, Ponce, Puerto Rico, 00780
        • San Cristobal Hosp
      • San Juan, Puerto Rico, 009091711
        • Clinical Research Puerto Rico Inc
  • Spain
      • Barcelona, Spain
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain
        • Hosp Clinic
      • Bilboa, Spain
        • Hosp de Basurto / Enfermedades Infecciosas
      • Cordoba, Spain
        • Hosp Reina Sofia
      • Madrid, Spain
        • Hosp Carlos III
      • Madris, Spain
        • Hosp Ramon y Cajal
      • Oviedo, Spain
        • Hosp Nuestra Senora de Covadonga
      • Sevilla, Spain
        • Hosp Virgen Del Rocio
  • United Kingdom
      • Birmingham, United Kingdom
        • Whittal Street Clinic
      • Liverpool, United Kingdom
        • Royal Liverpool Univ Hosp
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Cooper Green Hosp
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Phoenix Body Positive
    • California
      • Berkeley, California, United States, 94705
        • East Bay AIDS Ctr
      • San Francisco, California, United States, 94121
        • San Francisco Veterans Administration Med Ctr
      • San Francisco, California, United States, 94118
        • Kaiser Foundation Hospital
      • San Francisco, California, United States, 94109
        • Saint Francis Mem Hosp / HIV Care Unit
      • Torrance, California, United States, 90502
        • Harbor UCLA Med Ctr
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Beacon Clinic / Boulder Community Hosp
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • IDC Research Initiative
      • Atlantis, Florida, United States, 33462
        • Larry Bush
      • Fort Lauderdale, Florida, United States, 33306
        • Community Health Care
      • Miami Beach, Florida, United States, 33160
        • South Beach Medical Associates
      • Orlando, Florida, United States, 32801
        • Florida ID Group
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Infectious Disease Specialists of Atlanta
    • Hawaii
      • Honolulu, Hawaii, United States, 96816
        • Univ of Hawaii
    • Idaho
      • Boise, Idaho, United States, 83704
        • Sky Blue
    • Indiana
      • Indianapolis, Indiana, United States, 46218
        • Infectious Disease of Indiana
    • Kansas
      • Wichita, Kansas, United States, 672143124
        • Univ of Kansas School of Medicine
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Univ of Kentucky Med Ctr
    • Massachusetts
      • Brookline, Massachusetts, United States, 02445
        • Community Research Initiative
      • Worcester, Massachusetts, United States, 01655
        • Univ of Massachusetts
    • Missouri
      • St Louis, Missouri, United States, 63139
        • Southampton Healthcare Inc
    • Nevada
      • Reno, Nevada, United States, 89502
        • Steven Zell
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • VAMC New Jersey Healthcare System
      • Newark, New Jersey, United States, 071032842
        • North Jersey Community Research Initiative
    • New York
      • Albany, New York, United States, 12208
        • Albany Med College
      • Buffalo, New York, United States, 14215
        • Erie County Med Ctr
      • Manhasset, New York, United States, 11030
        • North Shore Univ Hosp
      • Rochester, New York, United States, 14620
        • Community Health Network
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Jemsek Clinic
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health Sciences Univ
      • Portland, Oregon, United States, 97209
        • Research & Education Group
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Mark Watkins
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Univ of South Carolina School of Medicine
    • Texas
      • Dallas, Texas, United States, 75246
        • Nicholas Bellos
      • Dallas, Texas, United States, 75208
        • North Texas Center for AIDS & Clinical Research
      • Houston, Texas, United States, 77006
        • Houston Clinical Research Network
      • Houston, Texas, United States, 77030
        • Infectious Diseases Associates of Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

September 1, 2003

Study Completion (Actual)

September 1, 2003

Study Registration Dates

First Submitted

December 20, 2001

First Submitted That Met QC Criteria

December 20, 2001

First Posted (Estimate)

December 21, 2001

Study Record Updates

Last Update Posted (Estimate)

September 13, 2010

Last Update Submitted That Met QC Criteria

September 10, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 302D
  • AI424-043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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