Back to resultsAtazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atazanavir
Lopinavir/Ritonavir
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV Protease Inhibitors, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Lipids, ABT 378, Antiretroviral Therapy, Highly Active, Lipoproteins, LDL Cholesterol
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.
Sites / Locations
- Cooper Green Hosp
- Phoenix Body Positive
- East Bay AIDS Ctr
- Saint Francis Mem Hosp / HIV Care Unit
- Kaiser Foundation Hospital
- San Francisco Veterans Administration Med Ctr
- Harbor UCLA Med Ctr
- Beacon Clinic / Boulder Community Hosp
- IDC Research Initiative
- Larry Bush
- Community Health Care
- South Beach Medical Associates
- Florida ID Group
- Infectious Disease Specialists of Atlanta
- Univ of Hawaii
- Sky Blue
- Infectious Disease of Indiana
- Univ of Kansas School of Medicine
- Univ of Kentucky Med Ctr
- Community Research Initiative
- Univ of Massachusetts
- Southampton Healthcare Inc
- Steven Zell
- VAMC New Jersey Healthcare System
- North Jersey Community Research Initiative
- Albany Med College
- Erie County Med Ctr
- North Shore Univ Hosp
- Community Health Network
- Jemsek Clinic
- Oregon Health Sciences Univ
- Research & Education Group
- Mark Watkins
- Univ of South Carolina School of Medicine
- North Texas Center for AIDS & Clinical Research
- Nicholas Bellos
- Houston Clinical Research Network
- Infectious Diseases Associates of Houston
- Claudia Rodriguez MD
- Elida Pallone MD
- Fundacion Huesped
- Hospital Italiano
- CAICI
- Alfred Hosp
- Prahran Market Clinic
- Saint Vincent's Hosp Med Centre
- Taylors Square Clinic
- Inst of Tropical Medicine
- CHU Saint Pierre
- Cliniques Universitaires Saint Luc
- University Hospital Gent
- Domaine Universitaire Du SART-TILMAN
- Hospital de Clinicas da Universidade Federal do Parana
- Hospital Nossa Senhora da Conceicao-GCH
- Instituto de Infectologia Emilio Ribas
- Toronto Hosp
- Clinique Medicale du Quartier Latin
- Dr Roger P Leblanc
- Montreal Gen Hosp / Div of Clin Immuno and Allergy
- Fundacion Arriaran
- Hosp Sotero de Rio
- Hopital Hotel Dieu de Lyon
- Services des Maladies Infectieuses
- CHU De Bicetre
- Hopital Cochin - Port Royal
- Hopital Gustave Dron
- Ospedale S Orsola
- Immunoligia Universita Cagliari
- Reparto di Malattie Infettive
- Ospedale Luigi Sacco Cargnel
- Ospedale S Raffaele
- Ospedale degli Infermi
- Cat All Immun Clin
- Ospedale Amedeo de Savoia
- Ospedale Amedeo di Savoia
- Hospital 1 ro de Octubre
- Hospital General
- Hospital Regional
- Instituto Nacional de la Nutricion
- Univ Medical Center Utrecht
- Hosp Guillermo Almenara-Medicina 1
- Hosp Nacional Cayetano Heredia
- San Cristobal Hosp
- Clinical Research Puerto Rico Inc
- Hosp Clinic
- Hospital Germans Trias I Pujol
- Hosp de Basurto / Enfermedades Infecciosas
- Hosp Reina Sofia
- Hosp Carlos III
- Hosp Ramon y Cajal
- Hosp Nuestra Senora de Covadonga
- Hosp Virgen Del Rocio
- Whittal Street Clinic
- Royal Liverpool Univ Hosp
- Aurora Hospital
- Department of Infection & Tropical Medicine
- Klinicka Chorobzkaznych AM
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00028301
First Posted
December 20, 2001
Last Updated
September 10, 2010
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00028301
Brief Title
Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
September 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Protease Inhibitors, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Lipids, ABT 378, Antiretroviral Therapy, Highly Active, Lipoproteins, LDL Cholesterol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Atazanavir
Intervention Type
Drug
Intervention Name(s)
Lopinavir/Ritonavir
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Cooper Green Hosp
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Phoenix Body Positive
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Saint Francis Mem Hosp / HIV Care Unit
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Kaiser Foundation Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
San Francisco Veterans Administration Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Harbor UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Beacon Clinic / Boulder Community Hosp
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
IDC Research Initiative
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Larry Bush
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Community Health Care
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33306
Country
United States
Facility Name
South Beach Medical Associates
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33160
Country
United States
Facility Name
Florida ID Group
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Infectious Disease Specialists of Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Univ of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Sky Blue
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Infectious Disease of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46218
Country
United States
Facility Name
Univ of Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
672143124
Country
United States
Facility Name
Univ of Kentucky Med Ctr
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Community Research Initiative
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
Facility Name
Univ of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Southampton Healthcare Inc
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63139
Country
United States
Facility Name
Steven Zell
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
VAMC New Jersey Healthcare System
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
North Jersey Community Research Initiative
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071032842
Country
United States
Facility Name
Albany Med College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Erie County Med Ctr
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
North Shore Univ Hosp
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Community Health Network
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Jemsek Clinic
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Oregon Health Sciences Univ
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Research & Education Group
City
Portland
State/Province
Oregon
ZIP/Postal Code
97209
Country
United States
Facility Name
Mark Watkins
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Univ of South Carolina School of Medicine
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
North Texas Center for AIDS & Clinical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
Nicholas Bellos
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Houston Clinical Research Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
Facility Name
Infectious Diseases Associates of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Claudia Rodriguez MD
City
Buenos Aires
Country
Argentina
Facility Name
Elida Pallone MD
City
Buenos Aires
Country
Argentina
Facility Name
Fundacion Huesped
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Italiano
City
Buenos Aires
Country
Argentina
Facility Name
CAICI
City
Rosario Santa Fe
Country
Argentina
Facility Name
Alfred Hosp
City
Prahan
Country
Australia
Facility Name
Prahran Market Clinic
City
South Yarra
Country
Australia
Facility Name
Saint Vincent's Hosp Med Centre
City
Sydney
Country
Australia
Facility Name
Taylors Square Clinic
City
Sydney
Country
Australia
Facility Name
Inst of Tropical Medicine
City
Antwerpe
Country
Belgium
Facility Name
CHU Saint Pierre
City
Brussels
Country
Belgium
Facility Name
Cliniques Universitaires Saint Luc
City
Bruxelles
Country
Belgium
Facility Name
University Hospital Gent
City
Gent
Country
Belgium
Facility Name
Domaine Universitaire Du SART-TILMAN
City
Liege
Country
Belgium
Facility Name
Hospital de Clinicas da Universidade Federal do Parana
City
Curitiba
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao-GCH
City
Porto Alegre
Country
Brazil
Facility Name
Instituto de Infectologia Emilio Ribas
City
Sao Paulo
Country
Brazil
Facility Name
Toronto Hosp
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Clinique Medicale du Quartier Latin
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Dr Roger P Leblanc
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Montreal Gen Hosp / Div of Clin Immuno and Allergy
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Fundacion Arriaran
City
Santiago
Country
Chile
Facility Name
Hosp Sotero de Rio
City
Santiago
Country
Chile
Facility Name
Hopital Hotel Dieu de Lyon
City
Lyon
Country
France
Facility Name
Services des Maladies Infectieuses
City
Paris Cedex 12
Country
France
Facility Name
CHU De Bicetre
City
Paris
Country
France
Facility Name
Hopital Cochin - Port Royal
City
Paris
Country
France
Facility Name
Hopital Gustave Dron
City
Tourcoing
Country
France
Facility Name
Ospedale S Orsola
City
Bologna
Country
Italy
Facility Name
Immunoligia Universita Cagliari
City
Cagliari
Country
Italy
Facility Name
Reparto di Malattie Infettive
City
Corso Svizzera
Country
Italy
Facility Name
Ospedale Luigi Sacco Cargnel
City
Milano
Country
Italy
Facility Name
Ospedale S Raffaele
City
Milano
Country
Italy
Facility Name
Ospedale degli Infermi
City
Rimini
Country
Italy
Facility Name
Cat All Immun Clin
City
Roma
Country
Italy
Facility Name
Ospedale Amedeo de Savoia
City
Torino
Country
Italy
Facility Name
Ospedale Amedeo di Savoia
City
Torino
Country
Italy
Facility Name
Hospital 1 ro de Octubre
City
Mexico City
Country
Mexico
Facility Name
Hospital General
City
Mexico City
Country
Mexico
Facility Name
Hospital Regional
City
Mexico City
Country
Mexico
Facility Name
Instituto Nacional de la Nutricion
City
Mexico City
Country
Mexico
Facility Name
Univ Medical Center Utrecht
City
CX Utrecht
Country
Netherlands
Facility Name
Hosp Guillermo Almenara-Medicina 1
City
Lima
Country
Peru
Facility Name
Hosp Nacional Cayetano Heredia
City
Lima
Country
Peru
Facility Name
San Cristobal Hosp
City
Coto Laurel, Ponce
ZIP/Postal Code
00780
Country
Puerto Rico
Facility Name
Clinical Research Puerto Rico Inc
City
San Juan
ZIP/Postal Code
009091711
Country
Puerto Rico
Facility Name
Hosp Clinic
City
Barcelona
Country
Spain
Facility Name
Hospital Germans Trias I Pujol
City
Barcelona
Country
Spain
Facility Name
Hosp de Basurto / Enfermedades Infecciosas
City
Bilboa
Country
Spain
Facility Name
Hosp Reina Sofia
City
Cordoba
Country
Spain
Facility Name
Hosp Carlos III
City
Madrid
Country
Spain
Facility Name
Hosp Ramon y Cajal
City
Madris
Country
Spain
Facility Name
Hosp Nuestra Senora de Covadonga
City
Oviedo
Country
Spain
Facility Name
Hosp Virgen Del Rocio
City
Sevilla
Country
Spain
Facility Name
Whittal Street Clinic
City
Birmingham
Country
United Kingdom
Facility Name
Royal Liverpool Univ Hosp
City
Liverpool
Country
United Kingdom
Facility Name
Aurora Hospital
Facility Name
Department of Infection & Tropical Medicine
Facility Name
Klinicka Chorobzkaznych AM
12. IPD Sharing Statement
Learn more about this trial
Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)
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