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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
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
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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
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Hawaii
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United States of America
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Illinois
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United States of America
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Kansas
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United States of America
State/province [11] 0 0
Massachusetts
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United States of America
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New Jersey
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United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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Texas
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United States of America
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Washington
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Belgium
State/province [17] 0 0
Antwerpen
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Belgium
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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
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Quebec
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Germany
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Berlin
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Germany
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Bochum
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Germany
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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
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Hannover
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Germany
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Munchen
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Germany
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Stuttgart
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Israel
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Beer-Sheva
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Ramat-Gan
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Israel
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Rehovot
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Israel
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Tel Aviv
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Italy
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Antella
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Italy
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Ferrara
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Italy
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Genova
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Italy
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Milano
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Italy
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Modena
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Italy
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Napoli
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Italy
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Padova
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Italy
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Roma
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Italy
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Torino
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Peru
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Arequipa
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Peru
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Lima
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Khon Kaen
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Thailand
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Nonthaburi
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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
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 website
https://clinicaltrials.gov/ct2/show/NCT00612898
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00612898