Clinical trial NCT00028301: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-12-21
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

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