Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra as Their Second Protease Inhibitor
NCT ID: NCT00038519
Last Updated: 2006-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
16 participants
INTERVENTIONAL
2001-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Amprenavir/ritonavir
Saquinavir/ritonavir
Eligibility Criteria
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Inclusion Criteria
* Subject demonstrates reduced susceptibility to lopinavir.
* Subject's two most recent viral loads obtained after at least 16 weeks of lopinavir/ritonavir therapy, and while still on Kaletra therapy must be at least 1,000 copies/mL.
* The Kaletra regimen must be the subject's second PI containing regimen and must not contain any other PIs.
* Subject is at least 18 years of age.
* Subject has not been treated for an active opportunistic infection within 30 days of screening.
Exclusion:
* Subject has a history of active substance abuse or psychiatric illness that could preclude compliance to the protocol.
* Female subject pregnant or lactating.
* Use of an Investigational drug within 30 days prior to the initiation of drug dosing.
* Subject is receiving systemic chemotherapy.
* Subject has a history of acute or chronic pancreatitis.
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Principal Investigators
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Eugene Sun, M.D.
Role: STUDY_CHAIR
Divisional Vice President, Infectious Diseases and Virology Development
Locations
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Phoenix Body Positive, Inc.
Phoenix, Arizona, United States
AIDS Health Care Foundation - Research Center
Los Angeles, California, United States
20th Avenue Medical Center Kaiser Permanente
Denver, Colorado, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
IDC Research Initiative
Altamonte Springs, Florida, United States
Gary J. Richmond, M.D.
Fort Lauderdale, Florida, United States
Associates in Research
Fort Myers, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
Infectious Disease Research Institute, Inc.
Tampa, Florida, United States
AIDS Research Consortium of Atlanta, Inc.
Atlanta, Georgia, United States
CORE Center
Chicago, Illinois, United States
Donna E. Sweet, M.D.
Wichita, Kansas, United States
David Parks, M.D.
St Louis, Missouri, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
Howard A. Grossman, M.D.
New York, New York, United States
John B. Montana, M.D.
New York, New York, United States
State University of New York at Stony Brook
Stony Brook, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
The Research & Education Group
Portland, Oregon, United States
Bornemann Internal Medicine
Reading, Pennsylvania, United States
David Wright, M.D.
Austin, Texas, United States
Diversified Medical Practices, P.A.
Houston, Texas, United States
Hampton Roads Medical Specialists
Hampton, Virginia, United States
Hospital Muniz - FUNDAI
Buenos Aires, , Argentina
Fundacion Huesped
Buenos Aires, , Argentina
Hospital do Servidor Publico Estadual de Sao Paulo
São Paulo, São Paulo, Brazil
Hospital Evandro Chagas - Fiocryz
Rio de Janeiro, , Brazil
Hospital Heliopolis
São Paulo, , Brazil
Phillip Sestak, M.D
Vancouver, British Columbia, Canada
Ottawa Hospital General Campus
Ottawa, Ontario, Canada
Toronto General Hospital Division of The University Health Network
Toronto, Ontario, Canada
Montreal Chest Institute/Royal Victoria Hospital
Montreal, Quebec, Canada
Tour Drouet - C.H.U. Brabois
Vandœuvre-lès-Nancy, Cedex, France
Service du C.I.S.I.H. - C.H.U. de Grenoble
La Tronche, , France
Hospital Tenon
Paris, , France
Groupe Hospitalier Cochin -Saint-Vincent-de-Paul La Roche-Guyon
Paris, , France
Hospital Yves Le Foll
Saint-Brieuc, , France
La Seyne sur Mer, Hopital Chalucet
Toulon, , France
S. Raffaele Hospital
Milan, , Italy
III Infectious Diseases Division IRCCS "L. Spallanzani"
Rome, , Italy
IRCCS "L. Spallanzani"
Rome, , Italy
Hospital "Amedeo di Savoia"
Torino, , Italy
Wojewodzki Szpital Zakazny
Warsaw, , Poland
Centro Familiar, Inc
Ponce, , Puerto Rico
New Puerto Rico CONCRA
Rio Piedras, , Puerto Rico
Hospital Germans Trias I Pujol
Badalona, , Spain
Hospital De La Sta Creu I San Pau
Barcelona, , Spain
Hospital Clinic I Provincial
Barcelona, , Spain
Hospital Carlos III
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Hospital Universitario Vergen del Rocio
Seville, , Spain
Royal Free Hospital
London, , United Kingdom
Countries
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Other Identifiers
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M00-261
Identifier Type: -
Identifier Source: org_study_id