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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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/NCT00367952