Skip to main content
OpenTrials
Completed

NCT Number: NCT00332930

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

407 Doctors, Sydney, New South Wales, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

recombinant fowlpoxvirus (rFPV) expressing HIV gag-pol antigens

Biological

HIV gag-pol antigens and interferon-gamma (IFN-y)

Biological

Primary outcomes

  1. Time weighted area under the curve change from plasma HIV-RNA VL at baseline (day 0) until reintroduction of antiretroviral therapy

Secondary outcomes

  1. Log plasma HIV-RNA load after cessation of combination ART (post-vaccination viral load (VL) set-point)

  2. Kinetics and rate of VL recrudescence and median time to re-initiation of ART

  3. CD8+ T-cell responses to HIV antigens assessed through:

  4. Enzyme linked immunospot (ELISPOT) assay of IFN-y secreting cells

  5. Intracellular Cytokine Cytometry (ICC) for IFN-y and CD69

  6. Human Leucocyte Antigen (HLA) class I/ I matched tetramer analyses for HIV epitope specific CD8+/CD4+ T -cells

  7. CD4+/CD8+ T-cell count changes

Sponsors and collaborators

Lead sponsor

Kirby Institute

Other Gov

Collaborators

  • The University of New South Wales
  • Virax Pty. Ltd,

Registry information

Official study 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)

Important dates

Study start
2002
Study completion
2003
First posted
Jun 2, 2006
Registry last updated
Feb 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.