HIVPhase 1/2NCT00332930
ITV Extension Study
A Phase 1/2 study testing recombinant fowlpoxvirus (rFPV) expressing HIV gag-pol antigens and HIV gag-pol antigens and interferon-gamma (IFN-y) in people with HIV, run by Kirby Institute at 6 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- recombinant fowlpoxvirus (rFPV) expressing HIV gag-pol antigens and HIV gag-pol antigens and interferon-gamma (IFN-y)
- How many people
- 35 participants
- Where
- 6 sitesAustralia
- Study dates
- Sep 2002to Sep 2003
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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 Failure to adhere with this schedule without having first provided justification may result in the participant being withdrawn from the study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)
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Australia6 sites
The Alfred Hospital
Melbourne, Victoria, 3004
Carlton Clinic
Melbourne, Victoria, 3053
407 Doctors
Sydney, New South Wales, 2010
Ground Zero Medical Practice
Sydney, New South Wales, 2010
Holdsworth House Medical Practice
Sydney, New South Wales, 2010
St Vincents Hospital
Sydney, New South Wales, 2010
About this study
Official 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)
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).
Read the detailed description
A multi-centre, double-blind, placebo-controlled, 20-week parallel group extension study to the VIR-NCHR-01 protocol (ITV study). The purpose of the extension study is to assess the safety and virological effects of a therapeutic HIV vaccine strategy in HIV-1 infected adults currently enrolled in the ITV study after cessation of antiretroviral therapy. Two active candidate vaccines will be studied in this trial: The active treatment arms will receive recombinant fowlpoxvirus (rFPV) expressing HIV gag-pol antigens or HIV gag-pol antigens and interferon-gamma (IFN-y) in diluent. Vaccines will be delivered by intramuscular injection.
- Conditions
- HIV
- Being tested
- recombinant fowlpoxvirus (rFPV) expressing HIV gag-pol antigens, HIV gag-pol antigens and interferon-gamma (IFN-y)
- Keywords
- HIV, Therapeutic vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant fowlpoxvirus (rFPV) expressing HIV gag-pol antigensBiological
HIV gag-pol antigens and interferon-gamma (IFN-y)Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Time weighted area under the curve change from plasma HIV-RNA VL at baseline (day 0) until reintroduction of antiretroviral therapy
Secondary outcomes (7)
Log plasma HIV-RNA load after cessation of combination ART (post-vaccination viral load (VL) set-point)
Kinetics and rate of VL recrudescence and median time to re-initiation of ART
CD8+ T-cell responses to HIV antigens assessed through:
Enzyme linked immunospot (ELISPOT) assay of IFN-y secreting cells
Intracellular Cytokine Cytometry (ICC) for IFN-y and CD69
Human Leucocyte Antigen (HLA) class I/ I matched tetramer analyses for HIV epitope specific CD8+/CD4+ T -cells
CD4+/CD8+ T-cell count changes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2006 (estimated)
- Study startSep 2002
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 35 participants
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- The University of New South Wales, Virax Pty. Ltd,
- Investigators
- David A Cooper, AO DSc MD FRACP FRCPA FRCP, Principal investigator, National Centre in HIV Epidemiology and Clinical Research.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332930
- Sponsor's protocol ID
- VIR-NCHR-02
- Status last verified
- Jun 2006
- First submitted
- 1 Jun 2006
- Last updated
- 27 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT00332930
- Acronym / sponsor ID
- VIR-NCHR-02
- Conditions
- HIV
- Keywords
- HIV, Therapeutic vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- The University of New South Wales, Virax Pty. Ltd,
- Study start
- Sep 2002
- Study completion
- Sep 2003
- First posted
- 2 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
A multi-centre, double-blind, placebo-controlled, 20-week parallel group extension study to the VIR-NCHR-01 protocol (ITV study). The purpose of the extension study is to assess the safety and virological effects of a therapeutic HIV vaccine strategy in HIV-1 infected adults currently enrolled in the ITV study after cessation of antiretroviral therapy. Two active candidate vaccines will be studied in this trial: The active treatment arms will receive recombinant fowlpoxvirus (rFPV) expressing HIV gag-pol antigens or HIV gag-pol antigens and interferon-gamma (IFN-y) in diluent. Vaccines will be delivered by intramuscular injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant fowlpoxvirus (rFPV) expressing HIV gag-pol antigens | Biological | – |
| HIV gag-pol antigens and interferon-gamma (IFN-y) | Biological | – |
Primary outcome
Time weighted area under the curve change from plasma HIV-RNA VL at baseline (day 0) until reintroduction of antiretroviral therapy
7 secondary outcomes
Log plasma HIV-RNA load after cessation of combination ART (post-vaccination viral load (VL) set-point)
Kinetics and rate of VL recrudescence and median time to re-initiation of ART
CD8+ T-cell responses to HIV antigens assessed through:
Enzyme linked immunospot (ELISPOT) assay of IFN-y secreting cells
Intracellular Cytokine Cytometry (ICC) for IFN-y and CD69
Human Leucocyte Antigen (HLA) class I/ I matched tetramer analyses for HIV epitope specific CD8+/CD4+ T -cells
CD4+/CD8+ T-cell count changes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2007.
Related trials for HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
RecruitingPhase 2
Multiple Interventions With Distinct Anti-reservoir Activities in People on Antiretroviral Treatment
HIV - Human Immunodeficiency Virus
RecruitingPhase 2
CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
HSIL, High Grade Squamous Intraepithelial Lesion, HPV-Related Squamous Cell Carcinoma
Recruiting
Improving Engagement in HIV and Cancer Care in Zimbabwe
Cancer, HIV
RecruitingObservational study
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
HIV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Cooper, AO DSc MD FRACP FRCPA FRCP principal investigator
National Centre in HIV Epidemiology and Clinical Research.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing recombinant fowlpoxvirus (rFPV) expressing HIV gag-pol antigens and HIV gag-pol antigens and interferon-gamma (IFN-y) in people with HIV, run by Kirby Institute at 6 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time weighted area under the curve change from plasma HIV-RNA VL at baseline (day 0) until reintroduction of antiretroviral therapy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2007.