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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00126880




Registration number
NCT00126880
Ethics application status
Date submitted
3/08/2005
Date registered
5/08/2005
Date last updated
23/06/2011

Titles & IDs
Public title
AVX754 (a New Nucleoside Reverse Transcriptase Inhibitor [NRTI]) to Treat Drug-resistant HIV
Scientific title
A Phase II, Randomised, Double-blind, Dose-ranging Study of AVX754 Versus Lamivudine in Treatment-experienced HIV-1 Infected Patients With the M184V Mutation in Reverse Transcriptase
Secondary ID [1] 0 0
AVX-201
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
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AVX754
Treatment: Drugs - 3TC

Experimental: 600mg BID ATC - 600mg BID ATC

Experimental: 800mg BID ATC - 800mg BID ATC

Active comparator: 150mg BID 3TC - 150mg BID 3TC


Treatment: Drugs: AVX754
apricitabine, 600mg BID or 800mg BID

Treatment: Drugs: 3TC
3TC, 150mg BID
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in HIV RNA levels at day 21
Timepoint [1] 0 0
day 21
Primary outcome [2] 0 0
Time-weighted average change from baseline in HIV RNA levels through 21 days
Timepoint [2] 0 0
21 days
Secondary outcome [1] 0 0
Change from baseline in HIV RNA levels at days 7, 14, 21
Timepoint [1] 0 0
days 7, 14, 21
Secondary outcome [2] 0 0
Proportion of subjects with HIV RNA levels <400 or <50 at days 7, 14, 21, and weeks 24 and 48
Timepoint [2] 0 0
days 7, 14, 21, and weeks 24 and 48
Secondary outcome [3] 0 0
Change from baseline and change in ratio of CD4+ and CD8+ cells at day 21 and weeks 24 and 48
Timepoint [3] 0 0
day 21 and weeks 24 and 48

Eligibility
Key inclusion criteria
* HIV-1 infected
* M184V mutation in reverse transcriptase
* Currently taking lamivudine
* Viral load >2000 copies/ml
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Hepatitis B surface antigen positive
* Pregnant or breastfeeding females
* Hepatitis C RNA positive and 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)
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2008
Sample size
Target
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Avexa (co-ordinating sites in Australia and Argentina) - Melbourne
Recruitment postcode(s) [1] 0 0
3121 - Melbourne

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
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/NCT00126880