Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000443594
Ethics application status
Approved
Date submitted
24/08/2006
Date registered
17/10/2006
Date last updated
26/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Apricitabine (AVX754), a new nucleoside reverse transcriptase inhibitor (NRTI) to treat HIV
Scientific title
An open label extension study to evaluate the long term safety and efficacy of apricitabine in controlling Human Immunodeficiency Virus (HIV) viral load and disease progression in treatment-experienced HIV-1 infected subjects
Secondary ID [1] 252299 0
AVX-201E
Universal Trial Number (UTN)
Trial acronym
AVX-201E
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV infection 1415 0
Condition category
Condition code
Infection 1512 1512 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is an open label extension study of the long term safety of apricitabine in Human Immunodeficiency Virus Type 1 (HIV-1) infected subjects who have completed the AVX-201 study. Subjects will continue to receive 800mg apricitabine by mouth twice daily in addition to their other HIV medications for up to an additional 96 weeks (making 144 weeks in total). The study will measure the long term safety of continued apricitabine treatment in HIV-1 infected subjects who were part of the AVX-201 study.
Intervention code [1] 1325 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2088 0
Time to loss of virologic contro
Timepoint [1] 2088 0
Assessed at weeks 96 and 144
Primary outcome [2] 2089 0
Incidence of adverse events
Timepoint [2] 2089 0
Assessed at weeks 96 and 145
Secondary outcome [1] 3604 0
Change in viral load
Timepoint [1] 3604 0
At weeks 72, 96, 120 and 144.

Eligibility
Key inclusion criteria
HIV-1 infected males and non-pregnant, non-lactating females, when they entered the preceding AVX-201 studyCompleted the AVX-201 studyPlasma viral load <5000 copies/mlCD4 cells >50.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Withdrawal from AVX-201 study or major protocol violationfemale subjects who are pregnant or breastfeeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1647 0
Commercial sector/Industry
Name [1] 1647 0
Avexa Ltd
Country [1] 1647 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Avexa Ltd
Address
576 Swan St Richmond VIC 3121
Country
Australia
Secondary sponsor category [1] 1456 0
None
Name [1] 1456 0
None
Address [1] 1456 0
Country [1] 1456 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3096 0
Albion St Clinic Sydney
Ethics committee address [1] 3096 0
Ethics committee country [1] 3096 0
Australia
Date submitted for ethics approval [1] 3096 0
Approval date [1] 3096 0
21/08/2006
Ethics approval number [1] 3096 0
EXT 05/069
Ethics committee name [2] 3097 0
St Vincent's Hospital Sydney
Ethics committee address [2] 3097 0
Ethics committee country [2] 3097 0
Australia
Date submitted for ethics approval [2] 3097 0
Approval date [2] 3097 0
30/08/2006
Ethics approval number [2] 3097 0
H06/075
Ethics committee name [3] 3098 0
Alfred Hospital Melbourne
Ethics committee address [3] 3098 0
Ethics committee country [3] 3098 0
Australia
Date submitted for ethics approval [3] 3098 0
Approval date [3] 3098 0
03/10/2006
Ethics approval number [3] 3098 0
184/06

Summary
Brief summary
The study will measure how safe it is to continue with apricitabine treatment long term in people with HIV-1 infection who previously were treated with apricitabine for a shorter period in a previous study
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27932 0
Address 27932 0
Country 27932 0
Phone 27932 0
Fax 27932 0
Email 27932 0
Contact person for public queries
Name 10514 0
Dr Susan Cox
Address 10514 0
Avexa
576 Swan St
Richmond VIC 3121
Country 10514 0
Australia
Phone 10514 0
+61 3 92084066
Fax 10514 0
+61 3 92084004
Email 10514 0
[email protected]
Contact person for scientific queries
Name 1442 0
Dr Susan Cox
Address 1442 0
Avexa
576 Swan St
Richmond VIC 3121
Country 1442 0
Australia
Phone 1442 0
+61 3 92084066
Fax 1442 0
+61 3 92084004
Email 1442 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.