Study of the Efficacy and Safety of Apricitabine, a New NRTI, to Treat Drug-resistant HIV Infection
- Registration Number
- NCT00612898
- Lead Sponsor
- Avexa
- Brief Summary
Apricitabine is a new NRTI which is active against drug-resistant HIV. NRTIs are often included as part of patients' treatment, but many HIV-infected patients develop resistance to commonly used NRTIs such as lamivudine (3TC) and emtricitabine (FTC). This study will examine whether including apricitabine as part of patients' treatment is more effective than including lamivudine,when patients change treatment because of drug resistance.
- Detailed Description
ATC has potent antiviral activity both in vitro (against wild-type HIV-1 and HIV-1 with mutations in reverse transcriptase that confer resistance to NRTIs), and in clinical studies in both treatment-naïve and treatment-experienced patients with M184V, including in the presence of additional NRTI mutations in reverse transcriptase.
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 239
- HIV-1 positive with M184V/I mutation in reverse transcriptase;
- 18 years of age or older;
- Currently taking lamivudine (3TC) or emtricitabine (FTC)
- Female patients who are pregnant or breastfeeding;
- Current hepatitis B virus (HBV) infection;
- Current treatment for hepatitis C virus infection;
- Renal function not adequate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 lamivudine 150mg BID lamivudine plus optimised background 1 apricitabine 800mg BID apricitabine plus optimised background
- Primary Outcome Measures
Name Time Method Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W24 week 24
- Secondary Outcome Measures
Name Time Method Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W48 week 48 Time to loss of virological response (TLOVR analysis; FDA algorithm) at W12, W24 and W48 (<50 copies/mL) week 12, 24, and 48
Trial Locations
- Locations (100)
Summa Health System
🇺🇸Akron, Ohio, United States
Nicholaos C Bellos, MD, PA
🇺🇸Dallas, Texas, United States
University of Texas Medical Brach
🇺🇸Galveston, Texas, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
University Health Network
🇨🇦Toronto, Ontario, Canada
Gary Richmond, MD
🇺🇸Fort Lauderdale, Florida, United States
Azienda Ospedaliero-Universitaria di Modena Policlinico
🇮🇹Modena, Italy
Azienda Ospedaliera Cotugno
🇮🇹Napoli, Italy
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
Saint Michael's Medical Center
🇺🇸Newark, New Jersey, United States
I.D. Care, Inc.
🇺🇸Hillsborough, New Jersey, United States
Rambam Medical Center
🇮🇱Haifa, Israel
The Alfred
🇦🇺Melbourne, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Ubc Downtown I.D. Clinic
🇨🇦Vancouver, British Columbia, Canada
Carlton Clinic
🇦🇺Carlton, Victoria, Australia
Prahran Market Clinic
🇦🇺South Yarra, Victoria, Australia
The Chaim Sheba Medical Center
🇮🇱Ramat-Gan, Israel
Via Libre
🇵🇪Lima, Peru
Pharmongkutklao Hospital
🇹ðŸ‡Bangkok, Thailand
Sirraj Hospital, Mahidol Universoty
🇹ðŸ‡Bangkok, Thailand
Instituto De Investigacion Cientifica
🇵🇷Ponce, Puerto Rico
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
🇹ðŸ‡Bangkok, Thailand
Fenway Community Health Center
🇺🇸Boston, Massachusetts, United States
Community Research Intiative of New England
🇺🇸Boston, Massachusetts, United States
Therapeutic Concepts
🇺🇸Houston, Texas, United States
Resarch Access Network
🇺🇸Houston, Texas, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Kaiser Permanente Medical Center
🇺🇸San Francisco, California, United States
University of Hawaii
🇺🇸Honolulu, Hawaii, United States
University of Kansas School of Medicine
🇺🇸Wichita, Kansas, United States
Azienda Ospedaliera Universitaria di Ferrara Arcispedale S.Anna
🇮🇹Ferrara, Italy
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
Denver Health & Hospital Authority
🇺🇸Denver, Colorado, United States
The Research & Education Institute
🇺🇸Portland, Oregon, United States
Edgardo Rebagliati Hospital
🇵🇪Lima, Peru
AIDS Research Alliance
🇺🇸West Hollywood, California, United States
Living Hope Clinical Foundation, Inc
🇺🇸Long Beach, California, 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
Northwestern University
🇺🇸Chicago, Illinois, United States
North Texas Infectious Diseases Consultants, P.A.
🇺🇸Dallas, Texas, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
Tarrant County Infection Disease Associates
🇺🇸Fort Worth, Texas, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, 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
Prins Leopold Institute voor Tropische Geneeskunde
🇧🇪Antwerpen, Belgium
Melbourne Sexual Health Centre
🇦🇺Carlton, Victoria, Australia
Hopitaux IRIS Sud
🇧🇪Bruxelles, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec, Canada
Hamilton Health Sciences Corporation
🇨🇦Hamilton, Ontario, Canada
Charite-Universitatsmedizin Berlin
🇩🇪Berlin, Germany
Universitatsklinikum Essen
🇩🇪Essen, Germany
EPIMED GmbH
🇩🇪Berlin, Germany
Ruhr-Universitat Bochum
🇩🇪Bochum, Germany
Universitatsklinikum Bonn
🇩🇪Bonn, Germany
Klinikum Dortmund gGmbH
🇩🇪Dortmund, Germany
Klinikum der Johann-Wolfgang Goethe-Universitat
🇩🇪Frankfurt, Germany
Praxis Dr.Schneider
🇩🇪Furth, Germany
Dr. med. Birger Kuhlmann
🇩🇪Hannover, Germany
Praxis fuer Innere Medizin
🇩🇪Freiburg, Germany
Klinikum der Universitat Munchen - Innenstadt
🇩🇪Munchen, 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
🇮🇱Beer-Sheva, Israel
Tel-Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Hadassah University Hospital Ein Kerem
🇮🇱Jerusalem, Israel
Kaplan Medical Center
🇮🇱Rehovot, Israel
Ospedale S.Maria Annunziata
🇮🇹Antella, Italy
Fondazione Centro San Raffaele del Monte Tabor
🇮🇹Milano, Italy
Ospedale Luigi Sacco
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria San Martino
🇮🇹Genova, Italy
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Hospital Nacional CASE-EsSalud
🇵🇪Arequipa, Peru
Comprensorio Amedeo di Savoia - Birago Di Vische
🇮🇹Torino, Italy
Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
🇮🇹Roma, Italy
Investigaciones Medicas en Salud
🇵🇪Lima, Peru
Hospital Dos de Mayo
🇵🇪Lima, Peru
Hospital Nacional Cayetano Heredia
🇵🇪Lima, Peru
University of Puerto Rico
🇵🇷San Juan, Puerto Rico
Hope Clinical Research
🇵🇷San Juan, Puerto Rico
Mahidol University Hospital for Tropical Diseases
🇹ðŸ‡Bangkok, Thailand
Ramathibodi Hospital, Mahidol University
🇹ðŸ‡Bangkok, Thailand
Maharaj Nakorn Chiang Mai, Chiang Mai University
🇹ðŸ‡Chiang Mai, Thailand
Khon Kaen University
🇹ðŸ‡Khon Kaen, Thailand
Bamrasnaradura Institution
🇹ðŸ‡Nonthaburi, Thailand
Birmingham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
St Mary's Hospital
🇬🇧London, United Kingdom
Royal Free Hospital
🇬🇧London, United Kingdom
Guy's King's & St. Thomas' School of Medicine
🇬🇧London, United Kingdom
St Bartholomew's Hospital
🇬🇧London, United Kingdom