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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/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
The study will measure how safe and effective AVX754 (a new drug for the treatment of HIV) is
in treating HIV-1 infected people who have failed treatment with lamivudine.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00126880
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