ITV Extension Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00332930
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : February 27, 2007
The University of New South Wales
Virax Pty. Ltd,
Information provided by:
Kirby Institute

June 1, 2006
June 2, 2006
February 27, 2007
September 2002
Not Provided
Time weighted area under the curve change from plasma HIV-RNA VL at baseline (day 0) until reintroduction of antiretroviral therapy
Same as current
Complete list of historical versions of study NCT00332930 on Archive Site
  • 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
Same as current
Not Provided
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ITV Extension Study
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).
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.
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Biological: recombinant fowlpoxvirus (rFPV) expressing HIV gag-pol antigens
  • Biological: HIV gag-pol antigens and interferon-gamma (IFN-y)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2003
Not Provided

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Kirby Institute
  • The University of New South Wales
  • Virax Pty. Ltd,
Principal Investigator: David A Cooper, AO DSc MD FRACP FRCPA FRCP National Centre in HIV Epidemiology and Clinical Research.
Kirby Institute
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP