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

Primary Purpose

HIV Infections

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
apricitabine
lamivudine
Sponsored by
Avexa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV infection, Drug resistance, Reverse transcriptase inhibitor, Nucleoside analogue, treatment experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UAB, 845 19th St South, South Beville Biomedical Research Building
  • University of Alabama at Birmingham
  • Southwest Center for HIV/AIDS
  • Living Hope Clinical Foundation, Inc
  • Kaiser Permanente Medical Center
  • AIDS Research Alliance
  • Denver Health & Hospital Authority
  • Georgetown University
  • George Washington University
  • Gary Richmond, MD
  • Orlando Immunology Center
  • Infectious Disease Research Institute, Inc
  • Treasure Coast Infectious Diseases Consultants
  • Aids Research Consortium Of Atlanta Inc.
  • Atlanta Infectious Disease Group, PC
  • University of Hawaii
  • Northwestern University
  • University of Kansas School of Medicine
  • Fenway Community Health Center
  • Community Research Intiative of New England
  • I.D. Care, Inc.
  • Saint Michael's Medical Center
  • Summa Health System
  • The Research & Education Institute
  • Central Texas Clinical Research
  • Nicholaos C Bellos, MD, PA
  • North Texas Infectious Diseases Consultants, P.A.
  • Tarrant County Infection Disease Associates
  • University of Texas Medical Brach
  • Therapeutic Concepts
  • Resarch Access Network
  • DCOL Center for Clinical Research
  • Swedish Medical Center
  • 407 Doctors
  • Parramatta Sexual Health Clinic
  • Westmead Hospital
  • Carlton Clinic
  • Melbourne Sexual Health Centre
  • The Alfred
  • Royal Melbourne Hospital
  • Prahran Market Clinic
  • Prins Leopold Institute voor Tropische Geneeskunde
  • Hopitaux IRIS Sud
  • Cliniques Universitaires Saint-Luc
  • Ubc Downtown I.D. Clinic
  • Hamilton Health Sciences Corporation
  • University Health Network
  • Sunnybrook Health Sciences Centre
  • Centre Hospitalier Universitaire de Quebec
  • EPIMED GmbH
  • Charite-Universitatsmedizin Berlin
  • Ruhr-Universitat Bochum
  • Universitatsklinikum Bonn
  • Klinikum Dortmund gGmbH
  • Universitatsklinikum Essen
  • Klinikum der Johann-Wolfgang Goethe-Universitat
  • Praxis fuer Innere Medizin
  • Praxis Dr.Schneider
  • Dr. med. Birger Kuhlmann
  • Klinikum der Universitat Munchen - Innenstadt
  • Gemeinschaftspraxis E. Schnaitmann, Dr. med. A. Schaffert, Dr. med. A. Trein, Dr. med. E. Ibler
  • Praxis Dres. Ulmer, Frietsch, Muller
  • Soroka University Medical Center
  • Rambam Medical Center
  • Hadassah University Hospital Ein Kerem
  • The Chaim Sheba Medical Center
  • Kaplan Medical Center
  • Tel-Aviv Sourasky Medical Center
  • Ospedale S.Maria Annunziata
  • Azienda Ospedaliera Universitaria di Ferrara Arcispedale S.Anna
  • Azienda Ospedaliera Universitaria San Martino
  • Fondazione Centro San Raffaele del Monte Tabor
  • Ospedale Luigi Sacco
  • Azienda Ospedaliero-Universitaria di Modena Policlinico
  • Azienda Ospedaliera Cotugno
  • Azienda Ospedaliera di Padova
  • Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
  • Comprensorio Amedeo di Savoia - Birago Di Vische
  • Hospital Nacional CASE-EsSalud
  • Investigaciones Medicas en Salud
  • Hospital Dos de Mayo
  • Via Libre
  • Hospital Nacional Cayetano Heredia
  • Edgardo Rebagliati Hospital
  • Instituto De Investigacion Cientifica
  • University of Puerto Rico
  • Hope Clinical Research
  • Mahidol University Hospital for Tropical Diseases
  • Pharmongkutklao Hospital
  • The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
  • Ramathibodi Hospital, Mahidol University
  • Sirraj Hospital, Mahidol Universoty
  • Maharaj Nakorn Chiang Mai, Chiang Mai University
  • Khon Kaen University
  • Bamrasnaradura Institution
  • Birmingham Heartlands Hospital
  • St Bartholomew's Hospital
  • Royal Free Hospital
  • Guy's King's & St. Thomas' School of Medicine
  • St Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

800mg BID apricitabine plus optimised background

150mg BID lamivudine plus optimised background

Outcomes

Primary Outcome Measures

Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W24

Secondary Outcome Measures

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

Full Information

First Posted
January 30, 2008
Last Updated
January 19, 2012
Sponsor
Avexa
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1. Study Identification

Unique Protocol Identification Number
NCT00612898
Brief Title
Study of the Efficacy and Safety of Apricitabine, a New NRTI, to Treat Drug-resistant HIV Infection
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avexa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV infection, Drug resistance, Reverse transcriptase inhibitor, Nucleoside analogue, treatment experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
239 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
800mg BID apricitabine plus optimised background
Arm Title
2
Arm Type
Active Comparator
Arm Description
150mg BID lamivudine plus optimised background
Intervention Type
Drug
Intervention Name(s)
apricitabine
Other Intervention Name(s)
AVX754
Intervention Description
800mg BID apricitabine orally for 48 weeks
Intervention Type
Drug
Intervention Name(s)
lamivudine
Other Intervention Name(s)
3TC
Intervention Description
150mg BID lamivudine orally for 48 weeks
Primary Outcome Measure Information:
Title
Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W24
Time Frame
week 24
Secondary Outcome Measure Information:
Title
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
Title
Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W48
Time Frame
week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan W Cox, Ph D
Organizational Affiliation
Avexa Ltd
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michael Saag, MD
Organizational Affiliation
UAB Center for AIDS Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB, 845 19th St South, South Beville Biomedical Research Building
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-2170
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-2170
Country
United States
Facility Name
Southwest Center for HIV/AIDS
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Living Hope Clinical Foundation, Inc
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
AIDS Research Alliance
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Denver Health & Hospital Authority
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Gary Richmond, MD
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Infectious Disease Research Institute, Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Treasure Coast Infectious Diseases Consultants
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Aids Research Consortium Of Atlanta Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Atlanta Infectious Disease Group, PC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
University of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816-2333
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Fenway Community Health Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Community Research Intiative of New England
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-3319
Country
United States
Facility Name
I.D. Care, Inc.
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844-4254
Country
United States
Facility Name
Saint Michael's Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304-1430
Country
United States
Facility Name
The Research & Education Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97209
Country
United States
Facility Name
Central Texas Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Nicholaos C Bellos, MD, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
North Texas Infectious Diseases Consultants, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Tarrant County Infection Disease Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University of Texas Medical Brach
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0435
Country
United States
Facility Name
Therapeutic Concepts
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Resarch Access Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
DCOL Center for Clinical Research
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
407 Doctors
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Parramatta Sexual Health Clinic
City
Parramatta
State/Province
New South Wales
ZIP/Postal Code
2150
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Carlton Clinic
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Melbourne Sexual Health Centre
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
The Alfred
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Prahran Market Clinic
City
South Yarra
State/Province
Victoria
ZIP/Postal Code
3141
Country
Australia
Facility Name
Prins Leopold Institute voor Tropische Geneeskunde
City
Antwerpen
ZIP/Postal Code
2000
Country
Belgium
Facility Name
Hopitaux IRIS Sud
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Ubc Downtown I.D. Clinic
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2C7
Country
Canada
Facility Name
Hamilton Health Sciences Corporation
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
H5G 2C4
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
EPIMED GmbH
City
Berlin
ZIP/Postal Code
12157
Country
Germany
Facility Name
Charite-Universitatsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Ruhr-Universitat Bochum
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Universitatsklinikum Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Klinikum Dortmund gGmbH
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Universitatsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Klinikum der Johann-Wolfgang Goethe-Universitat
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Praxis fuer Innere Medizin
City
Freiburg
ZIP/Postal Code
79098
Country
Germany
Facility Name
Praxis Dr.Schneider
City
Furth
ZIP/Postal Code
90762
Country
Germany
Facility Name
Dr. med. Birger Kuhlmann
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Klinikum der Universitat Munchen - Innenstadt
City
Munchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Gemeinschaftspraxis E. Schnaitmann, Dr. med. A. Schaffert, Dr. med. A. Trein, Dr. med. E. Ibler
City
Stuttgart
ZIP/Postal Code
70197
Country
Germany
Facility Name
Praxis Dres. Ulmer, Frietsch, Muller
City
Stuttgart
ZIP/Postal Code
70197
Country
Germany
Facility Name
Soroka University Medical Center
City
Beer-Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah University Hospital Ein Kerem
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Ospedale S.Maria Annunziata
City
Antella
ZIP/Postal Code
50011
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria di Ferrara Arcispedale S.Anna
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione Centro San Raffaele del Monte Tabor
City
Milano
ZIP/Postal Code
20127
Country
Italy
Facility Name
Ospedale Luigi Sacco
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Modena Policlinico
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Azienda Ospedaliera Cotugno
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
City
Roma
ZIP/Postal Code
149
Country
Italy
Facility Name
Comprensorio Amedeo di Savoia - Birago Di Vische
City
Torino
ZIP/Postal Code
10149
Country
Italy
Facility Name
Hospital Nacional CASE-EsSalud
City
Arequipa
ZIP/Postal Code
0
Country
Peru
Facility Name
Investigaciones Medicas en Salud
City
Lima
ZIP/Postal Code
14
Country
Peru
Facility Name
Hospital Dos de Mayo
City
Lima
ZIP/Postal Code
1
Country
Peru
Facility Name
Via Libre
City
Lima
ZIP/Postal Code
1
Country
Peru
Facility Name
Hospital Nacional Cayetano Heredia
City
Lima
ZIP/Postal Code
31
Country
Peru
Facility Name
Edgardo Rebagliati Hospital
City
Lima
Country
Peru
Facility Name
Instituto De Investigacion Cientifica
City
Ponce
ZIP/Postal Code
731
Country
Puerto Rico
Facility Name
University of Puerto Rico
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico
Facility Name
Hope Clinical Research
City
San Juan
ZIP/Postal Code
909
Country
Puerto Rico
Facility Name
Mahidol University Hospital for Tropical Diseases
City
Bangkok
ZIP/Postal Code
10270
Country
Thailand
Facility Name
Pharmongkutklao Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Ramathibodi Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Sirraj Hospital, Mahidol Universoty
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai, Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50002
Country
Thailand
Facility Name
Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Bamrasnaradura Institution
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Guy's King's & St. Thomas' School of Medicine
City
London
ZIP/Postal Code
SE5 9RJ
Country
United Kingdom
Facility Name
St Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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