Study of the Efficacy and Safety of Apricitabine, a New NRTI, to Treat Drug-resistant HIV Infection
NCT ID: NCT00612898
Last Updated: 2012-01-23
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
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TERMINATED
PHASE2/PHASE3
239 participants
INTERVENTIONAL
2008-02-29
2010-01-31
Brief Summary
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Detailed Description
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The M184V mutation is most commonly present amongst patients failing regimens containing either of the two deoxycytidine analogs lamivudine and emtricitabine. Whilst lamivudine therapy is often maintained in patients harboring the M184V mutation in some settings, there are no deoxycytidine analogs currently available that effectively suppress replication of HIV-1 containing the M184V/I mutation, particularly in the presence of other additional NRTI mutations.
The purpose of this study is to extend the efficacy and safety established in study AVX-201 of ATC in patients who are HIV-1 infected and have failed treatment with lamivudine or emtricitabine and have confirmed M184V/I mutation. Patients to be enrolled will be failing their current lamivudine- or emtricitabine-containing regimen and therefore have limited remaining NRTI treatment options. This study will investigate whether it is possible to improve control of HIV-1 viral replication by including ATC within a treatment experienced patient's new optimized background regimen following ART treatment failure.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
800mg BID apricitabine plus optimised background
apricitabine
800mg BID apricitabine orally for 48 weeks
2
150mg BID lamivudine plus optimised background
lamivudine
150mg BID lamivudine orally for 48 weeks
Interventions
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apricitabine
800mg BID apricitabine orally for 48 weeks
lamivudine
150mg BID lamivudine orally for 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older;
* Currently taking lamivudine (3TC) or emtricitabine (FTC)
Exclusion Criteria
* Current hepatitis B virus (HBV) infection;
* Current treatment for hepatitis C virus infection;
* Renal function not adequate
18 Years
ALL
No
Sponsors
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Avexa
INDUSTRY
Responsible Party
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Principal Investigators
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Susan W Cox, Ph D
Role: STUDY_DIRECTOR
Avexa Ltd
Michael Saag, MD
Role: PRINCIPAL_INVESTIGATOR
UAB Center for AIDS Research
Locations
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UAB, 845 19th St South, South Beville Biomedical Research Building
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Southwest Center for HIV/AIDS
Phoenix, Arizona, United States
Living Hope Clinical Foundation, Inc
Long Beach, California, United States
Kaiser Permanente Medical Center
San Francisco, California, United States
AIDS Research Alliance
West Hollywood, California, United States
Denver Health & Hospital Authority
Denver, Colorado, United States
Georgetown University
Washington D.C., District of Columbia, United States
George Washington University
Washington D.C., District of Columbia, United States
Gary Richmond, MD
Fort Lauderdale, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Infectious Disease Research Institute, Inc
Tampa, Florida, United States
Treasure Coast Infectious Diseases Consultants
Vero Beach, Florida, United States
Aids Research Consortium Of Atlanta Inc.
Atlanta, Georgia, United States
Atlanta Infectious Disease Group, PC
Atlanta, Georgia, United States
University of Hawaii
Honolulu, Hawaii, United States
Northwestern University
Chicago, Illinois, United States
University of Kansas School of Medicine
Wichita, Kansas, United States
Fenway Community Health Center
Boston, Massachusetts, United States
Community Research Intiative of New England
Boston, Massachusetts, United States
I.D. Care, Inc.
Hillsborough, New Jersey, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
Summa Health System
Akron, Ohio, United States
The Research & Education Institute
Portland, Oregon, United States
Central Texas Clinical Research
Austin, Texas, United States
Nicholaos C Bellos, MD, PA
Dallas, Texas, United States
North Texas Infectious Diseases Consultants, P.A.
Dallas, Texas, United States
Tarrant County Infection Disease Associates
Fort Worth, Texas, United States
University of Texas Medical Brach
Galveston, Texas, United States
Therapeutic Concepts
Houston, Texas, United States
Resarch Access Network
Houston, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
407 Doctors
Darlinghurst, New South Wales, Australia
Parramatta Sexual Health Clinic
Parramatta, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Carlton Clinic
Carlton, Victoria, Australia
Melbourne Sexual Health Centre
Carlton, Victoria, Australia
The Alfred
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Prahran Market Clinic
South Yarra, Victoria, Australia
Prins Leopold Institute voor Tropische Geneeskunde
Antwerp, , Belgium
Hopitaux IRIS Sud
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Ubc Downtown I.D. Clinic
Vancouver, British Columbia, Canada
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, Canada
EPIMED GmbH
Berlin, , Germany
Charite-Universitatsmedizin Berlin
Berlin, , Germany
Ruhr-Universitat Bochum
Bochum, , Germany
Universitatsklinikum Bonn
Bonn, , Germany
Klinikum Dortmund gGmbH
Dortmund, , Germany
Universitatsklinikum Essen
Essen, , Germany
Klinikum der Johann-Wolfgang Goethe-Universitat
Frankfurt, , Germany
Praxis fuer Innere Medizin
Freiburg im Breisgau, , Germany
Praxis Dr.Schneider
Fürth, , Germany
Dr. med. Birger Kuhlmann
Hanover, , Germany
Klinikum der Universitat Munchen - Innenstadt
München, , Germany
Gemeinschaftspraxis E. Schnaitmann, Dr. med. A. Schaffert, Dr. med. A. Trein, Dr. med. E. Ibler
Stuttgart, , Germany
Praxis Dres. Ulmer, Frietsch, Muller
Stuttgart, , Germany
Soroka University Medical Center
Beersheba, , Israel
Rambam Medical Center
Haifa, , Israel
Hadassah University Hospital Ein Kerem
Jerusalem, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Kaplan Medical Center
Rehovot, , Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Ospedale S.Maria Annunziata
Antella, , Italy
Azienda Ospedaliera Universitaria di Ferrara Arcispedale S.Anna
Ferrara, , Italy
Azienda Ospedaliera Universitaria San Martino
Genova, , Italy
Fondazione Centro San Raffaele del Monte Tabor
Milan, , Italy
Ospedale Luigi Sacco
Milan, , Italy
Azienda Ospedaliero-Universitaria di Modena Policlinico
Modena, , Italy
Azienda Ospedaliera Cotugno
Napoli, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
Roma, , Italy
Comprensorio Amedeo di Savoia - Birago Di Vische
Torino, , Italy
Hospital Nacional CASE-EsSalud
Arequipa, , Peru
Investigaciones Medicas en Salud
Lima, , Peru
Hospital Dos de Mayo
Lima, , Peru
Via Libre
Lima, , Peru
Hospital Nacional Cayetano Heredia
Lima, , Peru
Edgardo Rebagliati Hospital
Lima, , Peru
Instituto De Investigacion Cientifica
Ponce, , Puerto Rico
University of Puerto Rico
San Juan, , Puerto Rico
Hope Clinical Research
San Juan, , Puerto Rico
Mahidol University Hospital for Tropical Diseases
Bangkok, , Thailand
Pharmongkutklao Hospital
Bangkok, , Thailand
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, , Thailand
Ramathibodi Hospital, Mahidol University
Bangkok, , Thailand
Sirraj Hospital, Mahidol Universoty
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai, Chiang Mai University
Chiang Mai, , Thailand
Khon Kaen University
Khon Kaen, , Thailand
Bamrasnaradura Institution
Nonthaburi, , Thailand
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Guy's King's & St. Thomas' School of Medicine
London, , United Kingdom
St Mary's Hospital
London, , United Kingdom
Countries
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Other Identifiers
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AVX-301
Identifier Type: -
Identifier Source: org_study_id
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