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

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00038519

Purpose

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

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 or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra (Lopinavir/Ritonavir) as Their Second Protease Inhibitor.

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Saquinavir Saquinavir mesylate 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:	16
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:

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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038519

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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
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
20th Avenue Medical Center Kaiser Permanente
Denver, Colorado, United States, 80205
United States, Florida
IDC Research Initiative
Altamonte Springs, Florida, United States, 32701
University of Miami School of Medicine
Miami, Florida, United States, 33136
Gary J. Richmond, M.D.
Ft. Lauderdale, Florida, United States, 33316
Associates in Research
Fort Myers, Florida, United States, 33901
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
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
Diversified Medical Practices, P.A.
Houston, Texas, United States, 77027
David Wright, M.D.
Austin, Texas, United States, 78705
United States, Virginia
Hampton Roads Medical Specialists
Hampton, Virginia, United States, 23666
Argentina
Hospital Muniz - FUNDAI
Buenos Aires, Argentina, 4304-2180
Fundacion Huesped
Buenos Aires, Argentina, 4981-1855
Brazil
Hospital Evandro Chagas - Fiocryz
Rio de Janeiro, Brazil, 21045-900
Hospital Heliopolis
Sao Paulo, Brazil, 01332-000
Brazil, SP
Hospital do Servidor Publico Estadual de Sao Paulo
Sao Paulo, SP, Brazil, 04029-000
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
France
Service du C.I.S.I.H. - C.H.U. de Grenoble
La Tronche, France, 38700
Hospital Yves Le Foll
Saint Brieuc, France, 22023
Groupe Hospitalier Cochin -Saint-Vincent-de-Paul La Roche-Guyon
PARIS, France, 75679
La Seyne sur Mer, Hopital Chalucet
TOULON, France, 83056
Hospital Tenon
Paris, France, 75020
France, Cedex
Tour Drouet - C.H.U. Brabois
Vandoeuvre, Cedex, France, 54511
Italy
III Infectious Diseases Division IRCCS "L. Spallanzani"
Rome, Italy, 00149
IRCCS "L. Spallanzani"
Rome, Italy, 00149
S. Raffaele Hospital
Milan, Italy, 20127
Hospital "Amedeo di Savoia"
Torino, Italy, 10149
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 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 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:	M00-261
Study First Received:	May 31, 2002
Last Updated:	July 27, 2006
ClinicalTrials.gov Identifier:	NCT00038519 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
Anti-Bacterial Agents
Amprenavir
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
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
Antitubercular Agents

ClinicalTrials.gov processed this record on November 27, 2009