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

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00038532

Purpose

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	Intervention	Phase
HIV Infections	Drug: Amprenavir/ritonavir Drug: Saquinavir/ritonavir Drug: Efavirenz	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Saquinavir Saquinavir mesylate Efavirenz Ritonavir VX 478

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

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

Estimated Enrollment:	24
Study Start Date:	April 2001

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

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.

Exclusion:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038532

Hide Study Locations

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
Paul J. Cimoch, M.D.
Fountain Valley, California, United States, 92780
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
Associates in Research
Fort Myers, Florida, United States, 33901
Gary J. Richmond, M.D.
Ft. Lauderdale, Florida, United States, 33316
IDC Research Initiative
Altamonte Springs, Florida, United States, 32701
Infectious Disease Research Institute, Inc.
Tampa, Florida, United States, 33614
University of Miami School of Medicine
Miami, Florida, United States, 33136
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
Howard A. Grossman, M.D.
New York, New York, United States, 10011
John B. Montana, 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
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0435
United States, Virginia
Hampton Roads Medical Specialists
Hampton, Virginia, United States, 23666
Argentina
Fundacion Huesped
Buenos Aires, Argentina, 4981-1855
Hospital Muniz - FUNDAI
Buenos Aires, Argentina, 4304-2180
Brazil
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
France
Hospital Yves Le Foll
Saint Brieuc, France, 22023
La Seyne sur Mer, Hopital Chalucet
TOULON, France, 83056
Hopital Michalon - C.H.U. de Grenoble
Grenoble, France, 38043
Hopital Tenon
Paris, France, 75970
Groupe Hospitalier Cochin -Saint-Vincent-de-Paul La Roche-Guyon
PARIS, France, 75679
C.H.U. Brabois - Tour Drouet, Rue du Morvan
Vandoeuvre, France, 54511
Germany
Institut fur Immunologie Pathologie und Molekularbiologie
Hamburg, Germany, 20099
Albrecht Ulmer, M.D.
Stuttgart, Germany, 70197
CORE Center
Berlin, Germany, 13353
Universitatsklinikum
Dusseldorf, Germany, 40225
Klinikum J.W. Goethe Universitat
Frankfurt, Germany, 60596
Italy
S. Raffaele Hospital
Milan, Italy, 20127
Poland
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
Spain
Hospital Clinic I Provincial
Barcelona, Spain, 08036
Hospital De La Sta Creu I San Pau
Barcelona, Spain, 08025
Hospital Germans Trias I Pujol
Badalona, Spain, 08916
Hospital Universitario Vergen del Rocio
Sevilla, Spain, 41013
Hospital La Paz
Madrid, Spain, 28046
Hospital Carlos III
Madrid,, Spain, 28010
United Kingdom
Royal Free Hospital
London,, United Kingdom, NW3 2QG

Sponsors and Collaborators

Abbott

Investigators

Study Chair:

Eugene Sun, M.D.

Divisional Vice President, Infectious Diseases and Virology Development

More Information

No publications provided

Study ID Numbers:	M01-287
Study First Received:	May 31, 2002
Last Updated:	March 29, 2008
ClinicalTrials.gov Identifier:	NCT00038532 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

treatment experienced
HIV

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Saquinavir
Infection
Reverse Transcriptase Inhibitors
Anti-Bacterial Agents
Amprenavir
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Efavirenz
RNA Virus Infections

HIV Protease Inhibitors
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Antibiotics, Antitubercular
Protease Inhibitors
Virus Diseases
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 27, 2009