Study of the Efficacy and Safety of Apricitabine, a New NRTI, to Treat Drug-resistant HIV Infection

January 19, 2012 updated by: Avexa

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

239

Phase

  • Phase 2
  • Phase 3

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

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • 407 Doctors
      • Parramatta, New South Wales, Australia, 2150
        • Parramatta Sexual Health Clinic
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • Melbourne Sexual Health Centre
      • Carlton, Victoria, Australia, 3053
        • Carlton Clinic
      • Melbourne, Victoria, Australia
        • The Alfred
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
      • South Yarra, Victoria, Australia, 3141
        • Prahran Market Clinic
  • Belgium
      • Antwerpen, Belgium, 2000
        • Prins Leopold Institute voor Tropische Geneeskunde
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Bruxelles, Belgium, 1000
        • Hôpitaux IRIS Sud
  • Canada
      • Quebec, Canada, G1V 4G2
        • Centre Hospitalier Universitaire de Quebec
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2C7
        • Ubc Downtown I.D. Clinic
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Hamilton Health Sciences Corporation
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, H5G 2C4
        • University Health Network
  • Germany
      • Berlin, Germany, 13353
        • Charite-Universitatsmedizin Berlin
      • Berlin, Germany, 12157
        • Epimed GmbH
      • Bochum, Germany, 44791
        • Ruhr-Universität Bochum
      • Bonn, Germany, 53105
        • Universitätsklinikum Bonn
      • Dortmund, Germany, 44137
        • Klinikum Dortmund Ggmbh
      • Essen, Germany, 45122
        • Universitatsklinikum Essen
      • Frankfurt, Germany, 60590
        • Klinikum der Johann-Wolfgang Goethe-Universitat
      • Freiburg, Germany, 79098
        • Praxis fuer Innere Medizin
      • Furth, Germany, 90762
        • Praxis Dr.Schneider
      • Hannover, Germany, 30159
        • Dr. med. Birger Kuhlmann
      • Munchen, Germany, 80336
        • Klinikum der Universitat Munchen - Innenstadt
      • Stuttgart, Germany, 70197
        • Gemeinschaftspraxis E. Schnaitmann, Dr. med. A. Schaffert, Dr. med. A. Trein, Dr. med. E. Ibler
      • Stuttgart, Germany, 70197
        • Praxis Dres. Ulmer, Frietsch, Muller
  • Israel
      • Beer-Sheva, Israel, 84101
        • Soroka University Medical Center
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah University Hospital Ein Kerem
      • Ramat-Gan, Israel, 52621
        • The Chaim Sheba Medical Center
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
      • Tel Aviv, Israel, 64239
        • Tel-Aviv Sourasky Medical Center
  • Italy
      • Antella, Italy, 50011
        • Ospedale S.Maria Annunziata
      • Ferrara, Italy, 44100
        • Azienda Ospedaliera Universitaria di Ferrara Arcispedale S.Anna
      • Genova, Italy, 16132
        • Azienda Ospedaliera Universitaria San Martino
      • Milano, Italy, 20157
        • Ospedale Luigi Sacco
      • Milano, Italy, 20127
        • Fondazione Centro San Raffaele del Monte Tabor
      • Modena, Italy, 41100
        • Azienda Ospedaliero-Universitaria di Modena Policlinico
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Cotugno
      • Padova, Italy, 35128
        • Azienda Ospedaliera di Padova
      • Roma, Italy, 149
        • Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
      • Torino, Italy, 10149
        • Comprensorio Amedeo di Savoia - Birago Di Vische
  • Peru
      • Arequipa, Peru
        • Hospital Nacional CASE-EsSalud
      • Lima, Peru, 31
        • Hospital Nacional Cayetano Heredia
      • Lima, Peru, 14
        • Investigaciones Medicas en Salud
      • Lima, Peru, 1
        • Hospital Dos De Mayo
      • Lima, Peru, 1
        • Via Libre
      • Lima, Peru
        • Edgardo Rebagliati Hospital
  • Puerto Rico
      • Ponce, Puerto Rico, 731
        • Instituto De Investigacion Cientifica
      • San Juan, Puerto Rico, 00936-5067
        • University of Puerto Rico
      • San Juan, Puerto Rico, 909
        • Hope Clinical Research
  • Thailand
      • Bangkok, Thailand, 10330
        • The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital, Mahidol University
      • Bangkok, Thailand, 10270
        • Mahidol University Hospital for Tropical Diseases
      • Bangkok, Thailand, 10330
        • Pharmongkutklao Hospital
      • Bangkok, Thailand, 10700
        • Sirraj Hospital, Mahidol Universoty
      • Chiang Mai, Thailand, 50002
        • Maharaj Nakorn Chiang Mai, Chiang Mai University
      • Khon Kaen, Thailand, 40002
        • Khon Kaen University
      • Nonthaburi, Thailand, 11000
        • Bamrasnaradura Institution
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • London, United Kingdom, Nw3 2QG
        • Royal Free Hospital
      • London, United Kingdom, W2 1NY
        • St Mary's Hospital
      • London, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital
      • London, United Kingdom, SE5 9RJ
        • Guy's King's & St. Thomas' School of Medicine
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-2170
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35294-2170
        • UAB, 845 19th St South, South Beville Biomedical Research Building
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Southwest Center For Hiv/Aids
    • California
      • Long Beach, California, United States, 90813
        • Living Hope Clinical Foundation, Inc
      • San Francisco, California, United States, 94115
        • Kaiser Permanente Medical Center
      • West Hollywood, California, United States, 90069
        • AIDS Research Alliance
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health & Hospital Authority
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University
      • Washington, District of Columbia, United States, 20007
        • Georgetown University
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Gary Richmond, MD
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center
      • Tampa, Florida, United States, 33614
        • Infectious Disease Research Institute, Inc
      • Vero Beach, Florida, United States, 32960
        • Treasure Coast Infectious Diseases Consultants
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Atlanta Infectious Disease Group, PC
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta Inc.
    • Hawaii
      • Honolulu, Hawaii, United States, 96816-2333
        • University of Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Kansas
      • Wichita, Kansas, United States, 67214
        • University of Kansas School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Fenway Community Health Center
      • Boston, Massachusetts, United States, 02215-3319
        • Community Research Intiative of New England
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844-4254
        • I.D. Care, Inc.
      • Newark, New Jersey, United States, 07102
        • Saint Michael's Medical Center
    • Ohio
      • Akron, Ohio, United States, 44304-1430
        • Summa Health System
    • Oregon
      • Portland, Oregon, United States, 97209
        • The Research & Education Institute
    • Texas
      • Austin, Texas, United States, 78705
        • Central Texas Clinical Research
      • Dallas, Texas, United States, 75246
        • North Texas Infectious Diseases Consultants, P.A.
      • Dallas, Texas, United States, 75204
        • Nicholaos C Bellos, MD, PA
      • Fort Worth, Texas, United States, 76104
        • Tarrant County Infection Disease Associates
      • Galveston, Texas, United States, 77555-0435
        • University of Texas Medical Brach
      • Houston, Texas, United States, 77004
        • Therapeutic Concepts
      • Houston, Texas, United States, 77098
        • Resarch Access Network
      • Longview, Texas, United States, 75605
        • DCOL Center for Clinical Research
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center

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 Criteria:

  • HIV-1 positive with M184V/I mutation in reverse transcriptase;
  • 18 years of age or older;
  • Currently taking lamivudine (3TC) or emtricitabine (FTC)

Exclusion Criteria:

  • 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 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
800mg BID apricitabine plus optimised background
Drug: apricitabine
800mg BID apricitabine orally for 48 weeks
Other Names:
  • AVX754
Active Comparator: 2
150mg BID lamivudine plus optimised background
Drug: lamivudine
150mg BID lamivudine orally for 48 weeks
Other Names:
  • 3TC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W24
Time Frame: week 24
week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to loss of virological response (TLOVR analysis; FDA algorithm) at W12, W24 and W48 (<50 copies/mL)
Time Frame: week 12, 24, and 48
week 12, 24, and 48
Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W48
Time Frame: week 48
week 48

Collaborators and Investigators

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

Sponsor

Avexa

Investigators

  • Study Director: Susan W Cox, Ph D, Avexa Ltd
  • Principal Investigator: Michael Saag, MD, UAB Center for AIDS Research

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

February 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

January 30, 2008

First Submitted That Met QC Criteria

February 11, 2008

First Posted (Estimate)

February 12, 2008

Study Record Updates

Last Update Posted (Estimate)

January 23, 2012

Last Update Submitted That Met QC Criteria

January 19, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVX-301

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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