Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)
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)
2 other identifiers
interventional
N/A
15 countries
94
Brief Summary
This study will compare 2 treatments in the way they affect cholesterol levels and the amount of HIV in the blood.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2001
94 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2001
CompletedFirst Submitted
Initial submission to the registry
December 20, 2001
CompletedFirst Posted
Study publicly available on registry
December 21, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2003
CompletedSeptember 13, 2010
September 1, 2010
2.6 years
December 20, 2001
September 10, 2010
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (97)
Cooper Green Hosp
Birmingham, Alabama, 35233, United States
Phoenix Body Positive
Phoenix, Arizona, 85006, United States
East Bay AIDS Ctr
Berkeley, California, 94705, United States
Saint Francis Mem Hosp / HIV Care Unit
San Francisco, California, 94109, United States
Kaiser Foundation Hospital
San Francisco, California, 94118, United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121, United States
Harbor UCLA Med Ctr
Torrance, California, 90502, United States
Beacon Clinic / Boulder Community Hosp
Boulder, Colorado, 80304, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
Larry Bush
Atlantis, Florida, 33462, United States
Community Health Care
Fort Lauderdale, Florida, 33306, United States
South Beach Medical Associates
Miami Beach, Florida, 33160, United States
Florida ID Group
Orlando, Florida, 32801, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30033, United States
Univ of Hawaii
Honolulu, Hawaii, 96816, United States
Sky Blue
Boise, Idaho, 83704, United States
Infectious Disease of Indiana
Indianapolis, Indiana, 46218, United States
Univ of Kansas School of Medicine
Wichita, Kansas, 672143124, United States
Univ of Kentucky Med Ctr
Lexington, Kentucky, 40536, United States
Community Research Initiative
Brookline, Massachusetts, 02445, United States
Univ of Massachusetts
Worcester, Massachusetts, 01655, United States
Southampton Healthcare Inc
St Louis, Missouri, 63139, United States
Steven Zell
Reno, Nevada, 89502, United States
VAMC New Jersey Healthcare System
East Orange, New Jersey, 07018, United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842, United States
Albany Med College
Albany, New York, 12208, United States
Erie County Med Ctr
Buffalo, New York, 14215, United States
North Shore Univ Hosp
Manhasset, New York, 11030, United States
Community Health Network
Rochester, New York, 14620, United States
Jemsek Clinic
Huntersville, North Carolina, 28078, United States
Oregon Health Sciences Univ
Portland, Oregon, 97201, United States
Research & Education Group
Portland, Oregon, 97209, United States
Mark Watkins
Philadelphia, Pennsylvania, 19107, United States
Univ of South Carolina School of Medicine
Columbia, South Carolina, 29203, United States
North Texas Center for AIDS & Clinical Research
Dallas, Texas, 75208, United States
Nicholas Bellos
Dallas, Texas, 75246, United States
Houston Clinical Research Network
Houston, Texas, 77006, United States
Infectious Diseases Associates of Houston
Houston, Texas, 77030, United States
Claudia Rodriguez MD
Buenos Aires, Argentina
Elida Pallone MD
Buenos Aires, Argentina
Fundacion Huesped
Buenos Aires, Argentina
Hospital Italiano
Buenos Aires, Argentina
CAICI
Rosario Santa Fe, Argentina
Alfred Hosp
Prahan, Australia
Prahran Market Clinic
South Yarra, Australia
Saint Vincent's Hosp Med Centre
Sydney, Australia
Taylors Square Clinic
Sydney, Australia
Inst of Tropical Medicine
Antwerp, Belgium
CHU Saint Pierre
Brussels, Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium
University Hospital Gent
Ghent, Belgium
Domaine Universitaire Du SART-TILMAN
Liège, Belgium
Hospital de Clinicas da Universidade Federal do Parana
Curitiba, Brazil
Hospital Nossa Senhora da Conceicao-GCH
Porto Alegre, Brazil
Instituto de Infectologia Emilio Ribas
São Paulo, Brazil
Toronto Hosp
Toronto, Ontario, Canada
Clinique Medicale du Quartier Latin
Montreal, Quebec, Canada
Dr Roger P Leblanc
Montreal, Quebec, Canada
Montreal Gen Hosp / Div of Clin Immuno and Allergy
Montreal, Quebec, Canada
Fundacion Arriaran
Santiago, Chile
Hosp Sotero de Rio
Santiago, Chile
Hopital Hotel Dieu de Lyon
Lyon, France
CHU De Bicetre
Paris, France
Hopital Cochin - Port Royal
Paris, France
Services des Maladies Infectieuses
Paris, France
Hopital Gustave Dron
Tourcoing, France
Ospedale S Orsola
Bologna, Italy
Immunoligia Universita Cagliari
Cagliari, Italy
Reparto di Malattie Infettive
Corso Svizzera, Italy
Ospedale Luigi Sacco Cargnel
Milan, Italy
Ospedale S Raffaele
Milan, Italy
Ospedale degli Infermi
Rimini, Italy
Cat All Immun Clin
Roma, Italy
Ospedale Amedeo de Savoia
Torino, Italy
Ospedale Amedeo di Savoia
Torino, Italy
Hospital 1 ro de Octubre
Mexico City, Mexico
Hospital General
Mexico City, Mexico
Hospital Regional
Mexico City, Mexico
Instituto Nacional de la Nutricion
Mexico City, Mexico
Univ Medical Center Utrecht
CX Utrecht, Netherlands
Hosp Guillermo Almenara-Medicina 1
Lima, Peru
Hosp Nacional Cayetano Heredia
Lima, Peru
San Cristobal Hosp
Coto Laurel, Ponce, 00780, Puerto Rico
Clinical Research Puerto Rico Inc
San Juan, 009091711, Puerto Rico
Hosp Clinic
Barcelona, Spain
Hospital Germans Trias I Pujol
Barcelona, Spain
Hosp de Basurto / Enfermedades Infecciosas
Bilboa, Spain
Hosp Reina Sofia
Córdoba, Spain
Hosp Carlos III
Madrid, Spain
Hosp Ramon y Cajal
Madris, Spain
Hosp Nuestra Senora de Covadonga
Oviedo, Spain
Hosp Virgen Del Rocio
Seville, Spain
Whittal Street Clinic
Birmingham, United Kingdom
Royal Liverpool Univ Hosp
Liverpool, United Kingdom
Aurora Hospital
Department of Infection & Tropical Medicine
Klinicka Chorobzkaznych AM
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 20, 2001
First Posted
December 21, 2001
Study Start
February 1, 2001
Primary Completion
September 1, 2003
Study Completion
September 1, 2003
Last Updated
September 13, 2010
Record last verified: 2010-09