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

March 29, 2008 updated by: Abbott

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 4304-2180
        • Hospital Muniz - FUNDAI
      • Buenos Aires, Argentina, 4981-1855
        • Fundación Huésped
  • Brazil
      • Sao Paulo, Brazil, 01332-000
        • Hospital Heliópolis
  • Canada
    • 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
      • Grenoble, France, 38043
        • Hopital Michalon - C.H.U. de Grenoble
      • Paris, France, 75970
        • Hôpital 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
      • Vandoeuvre, France, 54511
        • C.H.U. Brabois - Tour Drouet, Rue du Morvan
  • Germany
      • Berlin, Germany, 13353
        • CORE Center
      • Dusseldorf, Germany, 40225
        • Universitätsklinikum
      • Frankfurt, Germany, 60596
        • Klinikum J.W. Goethe Universitat
      • Hamburg, Germany, 20099
        • Institut fur Immunologie Pathologie und Molekularbiologie
      • Stuttgart, Germany, 70197
        • Albrecht Ulmer, M.D.
  • Italy
      • Milan, Italy, 20127
        • S. Raffaele Hospital
  • 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
      • Fountain Valley, California, United States, 92780
        • Paul J. Cimoch, M.D.
      • Los Angeles, California, United States, 90027
        • AIDS Health Care Foundation - Research Center
      • Los Angeles, California, United States, 90048
        • Tower Infectious Diseases Medical Associates
    • 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.
      • Galveston, Texas, United States, 77555-0435
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77027
        • Diversified Medical Practices, P.A.
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Hampton Roads Medical Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

April 1, 2008

Last Update Submitted That Met QC Criteria

March 29, 2008

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M01-287

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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