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

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.

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Amprenavir/ritonavir; Drug: Saquinavir/ritonavir

• Study Type: Interventional
• Enrollment: 16
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Chair: Eugene Sun, M.D., Divisional Vice President, Infectious Diseases and Virology Development

Study record dates

Study Major Dates

• Study Start: April 1, 2001

Study Registration Dates

• First Submitted: May 31, 2002
• First Submitted That Met QC Criteria: May 31, 2002
• First Posted (Estimate): June 3, 2002

Study Record Updates

• Last Update Posted (Estimate): July 28, 2006
• Last Update Submitted That Met QC Criteria: July 27, 2006
• Last Verified: July 1, 2006

More Information

Terms related to this study

• Keywords: HIV; treatment experienced
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Antitubercular Agents; Antibiotics, Antitubercular; Ritonavir; Amprenavir; Saquinavir
• Other Study ID Numbers: M00-261