Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART
NCT ID: NCT00038532
Last Updated: 2008-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2001-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Amprenavir/ritonavir
Saquinavir/ritonavir
Efavirenz
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abbott
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eugene Sun, M.D.
Role: STUDY_CHAIR
Divisional Vice President, Infectious Diseases and Virology Development
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phoenix Body Positive, Inc.
Phoenix, Arizona, United States
Paul J. Cimoch, M.D.
Fountain Valley, California, United States
AIDS Health Care Foundation - Research Center
Los Angeles, California, United States
Tower Infectious Diseases Medical Associates
Los Angeles, California, United States
20th Avenue Medical Center Kaiser Permanente
Denver, Colorado, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
IDC Research Initiative
Altamonte Springs, Florida, United States
Gary J. Richmond, M.D.
Fort Lauderdale, Florida, United States
Associates in Research
Fort Myers, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
Infectious Disease Research Institute, Inc.
Tampa, Florida, United States
AIDS Research Consortium of Atlanta, Inc.
Atlanta, Georgia, United States
CORE Center
Chicago, Illinois, United States
Donna E. Sweet, M.D.
Wichita, Kansas, United States
David Parks, M.D.
St Louis, Missouri, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
Howard A. Grossman, M.D.
New York, New York, United States
John B. Montana, M.D.
New York, New York, United States
State University of New York at Stony Brook
Stony Brook, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
The Research & Education Group
Portland, Oregon, United States
Bornemann Internal Medicine
Reading, Pennsylvania, United States
David Wright, M.D.
Austin, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Diversified Medical Practices, P.A.
Houston, Texas, United States
Hampton Roads Medical Specialists
Hampton, Virginia, United States
Hospital Muniz - FUNDAI
Buenos Aires, , Argentina
Fundacion Huesped
Buenos Aires, , Argentina
Hospital Heliopolis
São Paulo, , Brazil
Ottawa Hospital General Campus
Ottawa, Ontario, Canada
Toronto General Hospital Division of The University Health Network
Toronto, Ontario, Canada
Montreal Chest Institute/Royal Victoria Hospital
Montreal, Quebec, Canada
Hopital Michalon - C.H.U. de Grenoble
Grenoble, , France
Groupe Hospitalier Cochin -Saint-Vincent-de-Paul La Roche-Guyon
Paris, , France
Hopital Tenon
Paris, , France
Hospital Yves Le Foll
Saint-Brieuc, , France
La Seyne sur Mer, Hopital Chalucet
Toulon, , France
C.H.U. Brabois - Tour Drouet, Rue du Morvan
Vandœuvre-lès-Nancy, , France
CORE Center
Berlin, , Germany
Universitatsklinikum
Düsseldorf, , Germany
Klinikum J.W. Goethe Universitat
Frankfurt, , Germany
Institut fur Immunologie Pathologie und Molekularbiologie
Hamburg, , Germany
Albrecht Ulmer, M.D.
Stuttgart, , Germany
S. Raffaele Hospital
Milan, , Italy
Wojewodzki Szpital Zakazny
Warsaw, , Poland
Centro Familiar, Inc
Ponce, , Puerto Rico
New Puerto Rico CONCRA
Rio Piedras, , Puerto Rico
Hospital Germans Trias I Pujol
Badalona, , Spain
Hospital De La Sta Creu I San Pau
Barcelona, , Spain
Hospital Clinic I Provincial
Barcelona, , Spain
Hospital Carlos III
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Hospital Universitario Vergen del Rocio
Seville, , Spain
Royal Free Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M01-287
Identifier Type: -
Identifier Source: org_study_id
NCT00021619
Identifier Type: -
Identifier Source: nct_alias