Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000742673
Ethics application status
Approved
Date submitted
14/11/2005
Date registered
15/11/2005
Date last updated
15/11/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
AVX754 (nucleoside reverse transcriptase inhibitor) to treat drug resistant HIV
Scientific title
A Phase II, randomised, double-blinded, dose ranging study of AVX754 to reduce the viral load versus lamivudine in treatment experienced HIV-1 infected patients with the M184V mutation in reverse transcriptase.
Universal Trial Number (UTN)
Trial acronym
AVX-201
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 894 0
Condition category
Condition code
Infection 962 962 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
600mg or 800mg AVX754 (a new drug treatment of HIV) for 48 weeks.

This study is a phase IIb randomised, double-blind, multi-centre, dose-ranging, controlled parallel group study where lamivudine is the comparator. The study will enrol approximately 60 patients who will be followed for 48 weeks. The study will measure how safe and effective two doses of AVX754 (a new drug for the treatment of HIV) (600mg or 800mg) is compared to 150mg of lamivudine in treating HIV-1 infected people who have failed treatment with lamivudine.
Intervention code [1] 757 0
None
Comparator / control treatment
150mg Lamivudine for 48 weeks.
Control group
Active

Outcomes
Primary outcome [1] 1274 0
To evaluate the antiretroviral activity
Timepoint [1] 1274 0
After 21 days
Primary outcome [2] 1275 0
Viral dynamic of two doses of AVX754 versus lamivudine in treatment of experienced subjects who are HIV-1 positive with the M184V mutation in reverse transcriptase.
Timepoint [2] 1275 0
Primary outcome [3] 1276 0
To evaluate the safety of AVX754 in HIV-1 treatment experienced subjects.
Timepoint [3] 1276 0
Secondary outcome [1] 2304 0
Change from baseline in HIV RNA levels
Timepoint [1] 2304 0
At days 7, 14 and 21.
Secondary outcome [2] 2305 0
Proportion of subjects with HIV RNA levels <400 or <50
Timepoint [2] 2305 0
At days 7, 14, 21 and weeks 24 and 48.
Secondary outcome [3] 2306 0
Change from baseline and change in ratio of CD4+ and CD8+ cells
Timepoint [3] 2306 0
At day 21, Wk 24 and 48.

Eligibility
Key inclusion criteria
Informed consentHIV-1 infectedM184V mutation in reverse transcriptaseCurrently taking lamivudineViral load >2,000 copies/mlCD4+ T-cell count>50 cells.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hep B surface Antigen PositivePregnant or breast feeding femalesHepatitis C RNA positive requiring treatment.

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)
Central randomisation by fax. The study investigators and patients are blinded to randomisation allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation schedule is generated by computer software that incorporates a standard procedure for generating randomisation codes. Subjects randomised in a 1:1:1 ratio. Two-part computer-generated labels are used to blind the investigational product.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1060 0
Commercial sector/Industry
Name [1] 1060 0
Avexa Ltd
Country [1] 1060 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Avexa Ltd
Address
Country
Australia
Secondary sponsor category [1] 921 0
Commercial sector/Industry
Name [1] 921 0
Avexa Ltd
Address [1] 921 0
Country [1] 921 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2357 0
St Vincents Hospital
Ethics committee address [1] 2357 0
Ethics committee country [1] 2357 0
Australia
Date submitted for ethics approval [1] 2357 0
Approval date [1] 2357 0
Ethics approval number [1] 2357 0
Ethics committee name [2] 2358 0
Westmead Hospital
Ethics committee address [2] 2358 0
Ethics committee country [2] 2358 0
Australia
Date submitted for ethics approval [2] 2358 0
Approval date [2] 2358 0
Ethics approval number [2] 2358 0
Ethics committee name [3] 2359 0
Albion Street Clinic
Ethics committee address [3] 2359 0
Ethics committee country [3] 2359 0
Australia
Date submitted for ethics approval [3] 2359 0
Approval date [3] 2359 0
Ethics approval number [3] 2359 0
Ethics committee name [4] 2360 0
Alfred Hospital
Ethics committee address [4] 2360 0
Ethics committee country [4] 2360 0
Australia
Date submitted for ethics approval [4] 2360 0
Approval date [4] 2360 0
Ethics approval number [4] 2360 0
Ethics committee name [5] 2361 0
Prahran Market Clinic
Ethics committee address [5] 2361 0
Ethics committee country [5] 2361 0
Australia
Date submitted for ethics approval [5] 2361 0
Approval date [5] 2361 0
Ethics approval number [5] 2361 0
Ethics committee name [6] 2362 0
Carlton Clinic
Ethics committee address [6] 2362 0
Ethics committee country [6] 2362 0
Australia
Date submitted for ethics approval [6] 2362 0
Approval date [6] 2362 0
Ethics approval number [6] 2362 0
Ethics committee name [7] 2363 0
Gold Coast Sexual Health Clinic
Ethics committee address [7] 2363 0
Ethics committee country [7] 2363 0
Australia
Date submitted for ethics approval [7] 2363 0
Approval date [7] 2363 0
Ethics approval number [7] 2363 0

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

Contacts
Principal investigator
Name 35764 0
Address 35764 0
Country 35764 0
Phone 35764 0
Fax 35764 0
Email 35764 0
Contact person for public queries
Name 9946 0
Dr Susan Cox
Address 9946 0
Avexa
576 Swan St
Richmond VIC 3121
Country 9946 0
Australia
Phone 9946 0
+61 3 92084300
Fax 9946 0
+61 3 92084004
Email 9946 0
scox@avexa.com.au
Contact person for scientific queries
Name 874 0
Dr Susan Cox
Address 874 0
Avexa
576 Swan St
Richmond VIC 3121
Country 874 0
Australia
Phone 874 0
+61 3 92084300
Fax 874 0
+61 3 92084004
Email 874 0
scox@avexa.com.au

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.