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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/NCT00332930




Registration number
NCT00332930
Ethics application status
Date submitted
1/06/2006
Date registered
2/06/2006
Date last updated
27/02/2007

Titles & IDs
Public title
ITV Extension Study
Scientific title
An Extension Study to Protocol VIR-NCHR-01 to Assess the Antiretrovirological Properties of a Therapeutic HIV Vaccine Candidate Based on Recombinant Fowlpox Virus (rFPV) (ITV Extension Study)
Secondary ID [1] 0 0
VIR-NCHR-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - recombinant fowlpoxvirus (rFPV) expressing HIV gag-pol antigens
Other interventions - HIV gag-pol antigens and interferon-gamma (IFN-y)

Other interventions: recombinant fowlpoxvirus (rFPV) expressing HIV gag-pol antigens


Other interventions: HIV gag-pol antigens and interferon-gamma (IFN-y)
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time weighted area under the curve change from plasma HIV-RNA VL at baseline (day 0) until reintroduction of antiretroviral therapy
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Log plasma HIV-RNA load after cessation of combination ART (post-vaccination viral load (VL) set-point)
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Kinetics and rate of VL recrudescence and median time to re-initiation of ART
Timepoint [2] 0 0
Secondary outcome [3] 0 0
CD8+ T-cell responses to HIV antigens assessed through:
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Enzyme linked immunospot (ELISPOT) assay of IFN-y secreting cells
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Intracellular Cytokine Cytometry (ICC) for IFN-y and CD69
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Human Leucocyte Antigen (HLA) class I/ I matched tetramer analyses for HIV epitope specific CD8+/CD4+ T -cells
Timepoint [6] 0 0
Secondary outcome [7] 0 0
CD4+/CD8+ T-cell count changes
Timepoint [7] 0 0

Eligibility
Key inclusion criteria
- HIV-1 infected individuals eligible and still fulfilling the criteria for the
VIR-NCHR-01 protocol (ITV study)

- Received all 3 immunisations

- Remained in follow-up for at least 52 weeks

- Continued to take combination antiretroviral therapy with no evidence of treatment
failure at the time entering the roll-over phase

- Written informed consent obtained

Criteria for Withdrawal of Study Participants

- Incidental or progression of disease which, in the opinion of the principal
investigator, should preclude further study participation

- If the study participant required cytotoxic or immunosuppressive chemo- or radiation
therapy

- If the study participant required any medications that when combined with the study
vaccination, would in the opinion of the principal investigator, jeopardise the
validity of the individual's continued participation

- Administration of prohibited alternative therapy

- Study participant non-compliance

- All study participants are required to adhere to the protocol evaluation schedule.
Failure to adhere with this schedule without having first provided justification may
result in the participant being withdrawn from the study

- At the request of the study participant or principal investigator without prejudice to
future health care

- In the opinion of the investigator, if it is not in the patient's best interests to
continue the study

- At the request of the National Centre in HIV Epidemiology and Clinical Research
(NCHECR) with reasonable cause

- At the advice of the Data Safety Monitoring Board (DSMB)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/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
1/09/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
407 Doctors - Sydney
Recruitment hospital [2] 0 0
Ground Zero Medical Practice - Sydney
Recruitment hospital [3] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [4] 0 0
St Vincents Hospital - Sydney
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [6] 0 0
Carlton Clinic - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
3053 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of New South Wales
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Virax Pty. Ltd,
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this phase I/II therapeutic human immunodeficiency virus (HIV) vaccine
candidate study is to provide proof of concept for a HIV antigen delivery system in terms of
safety, virological effects and selected immune responses in HIV infected individuals after
cessation of antiretroviral combination therapy (ART).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00332930
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David A Cooper, AO DSc MD FRACP FRCPA FRCP
Address 0 0
National Centre in HIV Epidemiology and Clinical Research.
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/NCT00332930