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Study of the Efficacy and Safety of Apricitabine, a New NRTI, to Treat Drug-resistant HIV Infection
A Phase 2b/3, Randomized, Double Blind, Dose Confirming Study of the Safety, Efficacy and Tolerability of Apricitabine Versus Lamivudine in Treatment-experienced HIV-1 Infected Patients With the M184V/I Mutation in Reverse Transcriptase
1 other identifier
interventional
239
11 countries
100
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
Started Feb 2008
100 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2008
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 12, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedJanuary 23, 2012
January 1, 2012
1.9 years
January 30, 2008
January 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W24
week 24
Secondary Outcomes (2)
Time to loss of virological response (TLOVR analysis; FDA algorithm) at W12, W24 and W48 (<50 copies/mL)
week 12, 24, and 48
Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W48
week 48
Study Arms (2)
1
EXPERIMENTAL800mg BID apricitabine plus optimised background
2
ACTIVE COMPARATOR150mg BID lamivudine plus optimised background
Interventions
Eligibility Criteria
You may qualify if:
- HIV-1 positive with M184V/I mutation in reverse transcriptase;
- years of age or older;
- Currently taking lamivudine (3TC) or emtricitabine (FTC)
You may not qualify if:
- Female patients who are pregnant or breastfeeding;
- Current hepatitis B virus (HBV) infection;
- Current treatment for hepatitis C virus infection;
- Renal function not adequate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Avexalead
Study Sites (100)
UAB, 845 19th St South, South Beville Biomedical Research Building
Birmingham, Alabama, 35294-2170, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294-2170, United States
Southwest Center for HIV/AIDS
Phoenix, Arizona, 85006, United States
Living Hope Clinical Foundation, Inc
Long Beach, California, 90813, United States
Kaiser Permanente Medical Center
San Francisco, California, 94115, United States
AIDS Research Alliance
West Hollywood, California, 90069, United States
Denver Health & Hospital Authority
Denver, Colorado, 80204, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
George Washington University
Washington D.C., District of Columbia, 20037, United States
Gary Richmond, MD
Fort Lauderdale, Florida, 33316, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
Infectious Disease Research Institute, Inc
Tampa, Florida, 33614, United States
Treasure Coast Infectious Diseases Consultants
Vero Beach, Florida, 32960, United States
Aids Research Consortium Of Atlanta Inc.
Atlanta, Georgia, 30308, United States
Atlanta Infectious Disease Group, PC
Atlanta, Georgia, 30309, United States
University of Hawaii
Honolulu, Hawaii, 96816-2333, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Kansas School of Medicine
Wichita, Kansas, 67214, United States
Fenway Community Health Center
Boston, Massachusetts, 02115, United States
Community Research Intiative of New England
Boston, Massachusetts, 02215-3319, United States
I.D. Care, Inc.
Hillsborough, New Jersey, 08844-4254, United States
Saint Michael's Medical Center
Newark, New Jersey, 07102, United States
Summa Health System
Akron, Ohio, 44304-1430, United States
The Research & Education Institute
Portland, Oregon, 97209, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
Nicholaos C Bellos, MD, PA
Dallas, Texas, 75204, United States
North Texas Infectious Diseases Consultants, P.A.
Dallas, Texas, 75246, United States
Tarrant County Infection Disease Associates
Fort Worth, Texas, 76104, United States
University of Texas Medical Brach
Galveston, Texas, 77555-0435, United States
Therapeutic Concepts
Houston, Texas, 77004, United States
Resarch Access Network
Houston, Texas, 77098, United States
DCOL Center for Clinical Research
Longview, Texas, 75605, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
407 Doctors
Darlinghurst, New South Wales, 2010, Australia
Parramatta Sexual Health Clinic
Parramatta, New South Wales, 2150, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Carlton Clinic
Carlton, Victoria, 3053, Australia
Melbourne Sexual Health Centre
Carlton, Victoria, 3053, Australia
The Alfred
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Prahran Market Clinic
South Yarra, Victoria, 3141, Australia
Prins Leopold Institute voor Tropische Geneeskunde
Antwerp, 2000, Belgium
Hopitaux IRIS Sud
Brussels, 1000, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Ubc Downtown I.D. Clinic
Vancouver, British Columbia, V6Z 2C7, Canada
Hamilton Health Sciences Corporation
Hamilton, Ontario, L8N 3Z5, Canada
University Health Network
Toronto, Ontario, H5G 2C4, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, G1V 4G2, Canada
EPIMED GmbH
Berlin, 12157, Germany
Charite-Universitatsmedizin Berlin
Berlin, 13353, Germany
Ruhr-Universitat Bochum
Bochum, 44791, Germany
Universitatsklinikum Bonn
Bonn, 53105, Germany
Klinikum Dortmund gGmbH
Dortmund, 44137, Germany
Universitatsklinikum Essen
Essen, 45122, Germany
Klinikum der Johann-Wolfgang Goethe-Universitat
Frankfurt, 60590, Germany
Praxis fuer Innere Medizin
Freiburg im Breisgau, 79098, Germany
Praxis Dr.Schneider
Fürth, 90762, Germany
Dr. med. Birger Kuhlmann
Hanover, 30159, Germany
Klinikum der Universitat Munchen - Innenstadt
München, 80336, Germany
Gemeinschaftspraxis E. Schnaitmann, Dr. med. A. Schaffert, Dr. med. A. Trein, Dr. med. E. Ibler
Stuttgart, 70197, Germany
Praxis Dres. Ulmer, Frietsch, Muller
Stuttgart, 70197, Germany
Soroka University Medical Center
Beersheba, 84101, Israel
Rambam Medical Center
Haifa, 31096, Israel
Hadassah University Hospital Ein Kerem
Jerusalem, 91120, Israel
The Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Ospedale S.Maria Annunziata
Antella, 50011, Italy
Azienda Ospedaliera Universitaria di Ferrara Arcispedale S.Anna
Ferrara, 44100, Italy
Azienda Ospedaliera Universitaria San Martino
Genova, 16132, Italy
Fondazione Centro San Raffaele del Monte Tabor
Milan, 20127, Italy
Ospedale Luigi Sacco
Milan, 20157, Italy
Azienda Ospedaliero-Universitaria di Modena Policlinico
Modena, 41100, Italy
Azienda Ospedaliera Cotugno
Napoli, 80131, Italy
Azienda Ospedaliera di Padova
Padua, 35128, Italy
Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
Roma, 149, Italy
Comprensorio Amedeo di Savoia - Birago Di Vische
Torino, 10149, Italy
Hospital Nacional CASE-EsSalud
Arequipa, 0, Peru
Investigaciones Medicas en Salud
Lima, 14, Peru
Hospital Dos de Mayo
Lima, 1, Peru
Via Libre
Lima, 1, Peru
Hospital Nacional Cayetano Heredia
Lima, 31, Peru
Edgardo Rebagliati Hospital
Lima, Peru
Instituto De Investigacion Cientifica
Ponce, 731, Puerto Rico
University of Puerto Rico
San Juan, 00936-5067, Puerto Rico
Hope Clinical Research
San Juan, 909, Puerto Rico
Mahidol University Hospital for Tropical Diseases
Bangkok, 10270, Thailand
Pharmongkutklao Hospital
Bangkok, 10330, Thailand
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, 10330, Thailand
Ramathibodi Hospital, Mahidol University
Bangkok, 10400, Thailand
Sirraj Hospital, Mahidol Universoty
Bangkok, 10700, Thailand
Maharaj Nakorn Chiang Mai, Chiang Mai University
Chiang Mai, 50002, Thailand
Khon Kaen University
Khon Kaen, 40002, Thailand
Bamrasnaradura Institution
Nonthaburi, 11000, Thailand
Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
St Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
Guy's King's & St. Thomas' School of Medicine
London, SE5 9RJ, United Kingdom
St Mary's Hospital
London, W2 1NY, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Susan W Cox, Ph D
Avexa Ltd
- PRINCIPAL INVESTIGATOR
Michael Saag, MD
UAB Center for AIDS Research
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2008
First Posted
February 12, 2008
Study Start
February 1, 2008
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
January 23, 2012
Record last verified: 2012-01