Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra as Their Second Protease Inhibitor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00038519
Recruitment Status : Completed
First Posted : June 3, 2002
Last Update Posted : July 28, 2006
Information provided by:

Brief Summary:
The purpose of this study is to study the safety and efficacy of Amprenavir/ritonavir or saquinavir/ritonavir in HIV infected patients that have failed Kaletra as their second protease inhibitor based HAART.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Amprenavir/ritonavir Drug: Saquinavir/ritonavir Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Phase II Study of Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra (Lopinavir/Ritonavir) as Their Second Protease Inhibitor.
Study Start Date : April 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Primary Outcome Measures :
  1. Proportion of subjects with plasma HIV RNA levels below the limit of quantification (400 copies/mL) at week 24 and the time until loss of virologic response through week 48

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Subject must remain on current antiretroviral therapy during screening until a new regimen is initiated.
  • 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.


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00038519

  Hide Study Locations
United States, Arizona
Phoenix Body Positive, Inc.
Phoenix,, Arizona, United States, 85006
United States, California
AIDS Health Care Foundation - Research Center
Los Angeles, California, United States, 90027
United States, Colorado
20th Avenue Medical Center Kaiser Permanente
Denver, Colorado, United States, 80205
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
United States, Florida
IDC Research Initiative
Altamonte Springs, Florida, United States, 32701
Associates in Research
Fort Myers, Florida, United States, 33901
Gary J. Richmond, M.D.
Ft. Lauderdale, Florida, United States, 33316
University of Miami School of Medicine
Miami, Florida, United States, 33136
Infectious Disease Research Institute, Inc.
Tampa, Florida, United States, 33614
United States, Georgia
AIDS Research Consortium of Atlanta, Inc.
Atlanta, Georgia, United States, 30308
United States, Illinois
CORE Center
Chicago, Illinois, United States, 60612
United States, Kansas
Donna E. Sweet, M.D.
Wichita, Kansas, United States, 67214
United States, Missouri
David Parks, M.D.
St. Louis, Missouri, United States, 63139
United States, New Jersey
Saint Michael's Medical Center
Newark, New Jersey, United States, 07102
United States, New York
John B. Montana, M.D.
New York,, New York, United States, 10011
Howard A. Grossman, M.D.
New York, New York, United States, 10011
State University of New York at Stony Brook
Stony Brook,, New York, United States, 11794-08153
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0405
United States, Oregon
The Research & Education Group
Portland, Oregon, United States, 97209
United States, Pennsylvania
Bornemann Internal Medicine
Reading, Pennsylvania, United States, 19601
United States, Texas
David Wright, M.D.
Austin, Texas, United States, 78705
Diversified Medical Practices, P.A.
Houston, Texas, United States, 77027
United States, Virginia
Hampton Roads Medical Specialists
Hampton, Virginia, United States, 23666
Hospital Muniz - FUNDAI
Buenos Aires, Argentina, 4304-2180
Fundacion Huesped
Buenos Aires, Argentina, 4981-1855
Hospital do Servidor Publico Estadual de Sao Paulo
Sao Paulo, SP, Brazil, 04029-000
Hospital Evandro Chagas - Fiocryz
Rio de Janeiro, Brazil, 21045-900
Hospital Heliopolis
Sao Paulo, Brazil, 01332-000
Canada, British Columbia
Phillip Sestak, M.D
Vancouver, British Columbia, Canada, V6Z 3T1
Canada, Ontario
Ottawa Hospital General Campus
Ottawa, Ontario, Canada, K1H 8L6
Toronto General Hospital Division of The University Health Network
Toronto, Ontario, Canada, M5G-2C4
Canada, Quebec
Montreal Chest Institute/Royal Victoria Hospital
Montreal, Quebec, Canada, H2X 2PA
Tour Drouet - C.H.U. Brabois
Vandoeuvre, Cedex, France, 54511
Service du C.I.S.I.H. - C.H.U. de Grenoble
La Tronche, France, 38700
Hospital Tenon
Paris, France, 75020
Groupe Hospitalier Cochin -Saint-Vincent-de-Paul La Roche-Guyon
Paris, France, 75679
Hospital Yves Le Foll
Saint Brieuc, France, 22023
La Seyne sur Mer, Hopital Chalucet
Toulon, France, 83056
S. Raffaele Hospital
Milan, Italy, 20127
III Infectious Diseases Division IRCCS "L. Spallanzani"
Rome, Italy, 00149
IRCCS "L. Spallanzani"
Rome, Italy, 00149
Hospital "Amedeo di Savoia"
Torino, Italy, 10149
Wojewodzki Szpital Zakazny
Warszawa, Poland, 01-201
Puerto Rico
Centro Familiar, Inc
Ponce, Puerto Rico, 00731
New Puerto Rico CONCRA
Rio Piedras, Puerto Rico, 00925
Hospital Germans Trias I Pujol
Badalona, Spain, 08916
Hospital De La Sta Creu I San Pau
Barcelona, Spain, 08025
Hospital Clinic I Provincial
Barcelona, Spain, 08036
Hospital Carlos III
Madrid,, Spain, 28010
Hospital La Paz
Madrid, Spain, 28046
Hospital Universitario Vergen del Rocio
Sevilla, Spain, 41013
United Kingdom
Royal Free Hospital
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Study Chair: Eugene Sun, M.D. Divisional Vice President, Infectious Diseases and Virology Development Identifier: NCT00038519     History of Changes
Other Study ID Numbers: M00-261
First Posted: June 3, 2002    Key Record Dates
Last Update Posted: July 28, 2006
Last Verified: July 2006

Keywords provided by Abbott:
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents