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.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00028301
First received: December 20, 2001
Last updated: September 10, 2010
Last verified: September 2010
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Atazanavir
HIV Protease Inhibitors
Lopinavir
Protease Inhibitors
Reverse Transcriptase Inhibitors
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014