Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART

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: NCT00038532
Recruitment Status : Completed
First Posted : June 3, 2002
Last Update Posted : April 1, 2008
Information provided by:

Brief Summary:
The purpose of this study is to study amprenavir/ritonavir, saquinavir/ritonavir or efavirenz in HIV-infected patients following failure with Kaletra (ABT-378/ritonavir) as their first protease inhibitor based HAART.

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 24 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, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART
Study Start Date : April 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Remain on present anti-HIV drugs during screening until a new regimen is started.
  • Have a viral load of at least 1,000 copies/ml on the 2 most recent tests after at least 24 weeks of lopinavir/ritonavir and while still on it.
  • Have an HIV which shows reduced susceptibility to lopinavir.
  • Are at least 18 years old.
  • Are not presently ill.
  • Have not been treated for an opportunistic infection within 30 days of screening.
  • Agree not to take certain drugs and agree to inform and get permission from the doctor before taking any medicines, over the counter medicines, herbal medicines, alcohol or recreational drugs.
  • Agree to use an accepted barrier method of birth control.


  • Female subject is pregnant or lactating.
  • Have taken any protease inhibitor other than lopinavir/ritonavir for more that two weeks.
  • Are taking chemotherapy.
  • Have a medical problem with their pancreas.
  • Have been screened for this study within the past 12 weeks.
  • Appear to be unsuitable in the opinion of the doctor.

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): NCT00038532

  Hide Study Locations
United States, Arizona
Phoenix Body Positive, Inc.
Phoenix,, Arizona, United States, 85006
United States, California
Paul J. Cimoch, M.D.
Fountain Valley, California, United States, 92780
AIDS Health Care Foundation - Research Center
Los Angeles, California, United States, 90027
Tower Infectious Diseases Medical Associates
Los Angeles, California, United States, 90048
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
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0435
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 Heliopolis
Sao Paulo, Brazil, 01332-000
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
Hopital Michalon - C.H.U. de Grenoble
Grenoble, France, 38043
Groupe Hospitalier Cochin -Saint-Vincent-de-Paul La Roche-Guyon
Paris, France, 75679
Hopital Tenon
Paris, France, 75970
Hospital Yves Le Foll
Saint Brieuc, France, 22023
La Seyne sur Mer, Hopital Chalucet
Toulon, France, 83056
C.H.U. Brabois - Tour Drouet, Rue du Morvan
Vandoeuvre, France, 54511
CORE Center
Berlin, Germany, 13353
Dusseldorf, Germany, 40225
Klinikum J.W. Goethe Universitat
Frankfurt, Germany, 60596
Institut fur Immunologie Pathologie und Molekularbiologie
Hamburg, Germany, 20099
Albrecht Ulmer, M.D.
Stuttgart, Germany, 70197
S. Raffaele Hospital
Milan, Italy, 20127
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: NCT00038532     History of Changes
Obsolete Identifiers: NCT00021619
Other Study ID Numbers: M01-287
First Posted: June 3, 2002    Key Record Dates
Last Update Posted: April 1, 2008
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
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers