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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/NCT00367952




Registration number
NCT00367952
Ethics application status
Date submitted
22/08/2006
Date registered
24/08/2006
Date last updated
23/06/2011

Titles & IDs
Public title
A Long Term, Safety Study of Apricitabine in HIV-infected Subjects
Scientific title
An Open Label Long Term Safety Extension Study of Apricitabine in Treatment-experienced HIV-1 Infected Subjects
Secondary ID [1] 0 0
AVX-201E
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infection 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 - apricitabine

Experimental: ATC 800mg BID - 800mg ATC BID


Treatment: Drugs: apricitabine
800mg apricitabine twice daily orally for 96 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to virological failure (DHSS definition)
Timepoint [1] 0 0
week 144
Primary outcome [2] 0 0
incidence of AEs and laboratory abnormalities
Timepoint [2] 0 0
Week 144
Primary outcome [3] 0 0
time to withdrawal due to AEs
Timepoint [3] 0 0
Week 144
Secondary outcome [1] 0 0
Change from baseline HIV RNA
Timepoint [1] 0 0
weeks 72, 96, 120, and 144
Secondary outcome [2] 0 0
Proportion of subjects with plasma HIV RNA <400 and <50 copies/ml
Timepoint [2] 0 0
at weeks 72, 96, 120, and 144
Secondary outcome [3] 0 0
Change from baseline and change in ratio of CD4+ and CD8+ counts
Timepoint [3] 0 0
at weeks 72, 96, 120, and 144

Eligibility
Key inclusion criteria
- Completed AVX-201 protocol, Plasma HIV RNA <5000 copies/ml, CD4 cells >50
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant or breastfeeding females, withdrawal from AVX-201

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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2010
Sample size
Target
Accrual to date
Final
42
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 examine how safe and effective apricitabine is when given long term (as
ongoing treatment) to HIV patients who have already completed the AVX-201 trial
Trial website
https://clinicaltrials.gov/ct2/show/NCT00367952
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00367952