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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00038519
First received: May 31, 2002
Last updated: July 27, 2006
Last verified: July 2006
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  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
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
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
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 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
France
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
Groupe Hospitalier Cochin -Saint-Vincent-de-Paul La Roche-Guyon
Paris, France, 75679
Hospital Tenon
Paris, France, 75020
Hospital Yves Le Foll
Saint Brieuc, France, 22023
La Seyne sur Mer, Hopital Chalucet
Toulon, France, 83056
Italy
S. Raffaele Hospital
Milan, Italy, 20127
IRCCS "L. Spallanzani"
Rome, Italy, 00149
III Infectious Diseases Division IRCCS "L. Spallanzani"
Rome, Italy, 00149
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 La Paz
Madrid, Spain, 28046
Hospital Carlos III
Madrid,, Spain, 28010
Hospital Universitario Vergen del Rocio
Sevilla, Spain, 41013
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

ClinicalTrials.gov Identifier: NCT00038519     History of Changes
Other Study ID Numbers: M00-261
Study First Received: May 31, 2002
Last Updated: July 27, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
treatment experienced
HIV

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Amprenavir
HIV Protease Inhibitors
Protease Inhibitors
Ritonavir
Saquinavir
Anti-Bacterial Agents
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antibiotics, Antitubercular
Antitubercular Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014