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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00612898




Registration number
NCT00612898
Ethics application status
Date submitted
30/01/2008
Date registered
12/02/2008
Date last updated
23/01/2012

Titles & IDs
Public title
Study of the Efficacy and Safety of Apricitabine, a New NRTI, to Treat Drug-resistant HIV Infection
Scientific 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
Secondary ID [1] 0 0
AVX-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - apricitabine
Treatment: Drugs - lamivudine

Experimental: 1 - 800mg BID apricitabine plus optimised background

Active comparator: 2 - 150mg BID lamivudine plus optimised background


Treatment: Drugs: apricitabine
800mg BID apricitabine orally for 48 weeks

Treatment: Drugs: lamivudine
150mg BID lamivudine orally for 48 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W24
Timepoint [1] 0 0
week 24
Secondary outcome [1] 0 0
Time to loss of virological response (TLOVR analysis; FDA algorithm) at W12, W24 and W48 (<50 copies/mL)
Timepoint [1] 0 0
week 12, 24, and 48
Secondary outcome [2] 0 0
Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W48
Timepoint [2] 0 0
week 48

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2010
Sample size
Target
Accrual to date
Final
239
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
407 Doctors - Darlinghurst
Recruitment hospital [2] 0 0
Parramatta Sexual Health Clinic - Parramatta
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Carlton Clinic - Carlton
Recruitment hospital [5] 0 0
Melbourne Sexual Health Centre - Carlton
Recruitment hospital [6] 0 0
The Alfred - Melbourne
Recruitment hospital [7] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [8] 0 0
Prahran Market Clinic - South Yarra
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2150 - Parramatta
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment postcode(s) [7] 0 0
3141 - South Yarra
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Hawaii
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Belgium
State/province [17] 0 0
Antwerpen
Country [18] 0 0
Belgium
State/province [18] 0 0
Bruxelles
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Germany
State/province [22] 0 0
Berlin
Country [23] 0 0
Germany
State/province [23] 0 0
Bochum
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Germany
State/province [24] 0 0
Bonn
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Germany
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Dortmund
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Germany
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Essen
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Germany
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Frankfurt
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Germany
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Freiburg
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Germany
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Furth
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Germany
State/province [30] 0 0
Hannover
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Germany
State/province [31] 0 0
Munchen
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Germany
State/province [32] 0 0
Stuttgart
Country [33] 0 0
Israel
State/province [33] 0 0
Beer-Sheva
Country [34] 0 0
Israel
State/province [34] 0 0
Haifa
Country [35] 0 0
Israel
State/province [35] 0 0
Jerusalem
Country [36] 0 0
Israel
State/province [36] 0 0
Ramat-Gan
Country [37] 0 0
Israel
State/province [37] 0 0
Rehovot
Country [38] 0 0
Israel
State/province [38] 0 0
Tel Aviv
Country [39] 0 0
Italy
State/province [39] 0 0
Antella
Country [40] 0 0
Italy
State/province [40] 0 0
Ferrara
Country [41] 0 0
Italy
State/province [41] 0 0
Genova
Country [42] 0 0
Italy
State/province [42] 0 0
Milano
Country [43] 0 0
Italy
State/province [43] 0 0
Modena
Country [44] 0 0
Italy
State/province [44] 0 0
Napoli
Country [45] 0 0
Italy
State/province [45] 0 0
Padova
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Italy
State/province [46] 0 0
Roma
Country [47] 0 0
Italy
State/province [47] 0 0
Torino
Country [48] 0 0
Peru
State/province [48] 0 0
Arequipa
Country [49] 0 0
Peru
State/province [49] 0 0
Lima
Country [50] 0 0
Puerto Rico
State/province [50] 0 0
Ponce
Country [51] 0 0
Puerto Rico
State/province [51] 0 0
San Juan
Country [52] 0 0
Thailand
State/province [52] 0 0
Bangkok
Country [53] 0 0
Thailand
State/province [53] 0 0
Chiang Mai
Country [54] 0 0
Thailand
State/province [54] 0 0
Khon Kaen
Country [55] 0 0
Thailand
State/province [55] 0 0
Nonthaburi
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Birmingham
Country [57] 0 0
United Kingdom
State/province [57] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Avexa
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Susan W Cox, Ph D
Address 0 0
Avexa Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00612898