NCT00332930

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1 hiv

Timeline
Completed

Started Sep 2002

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2006

Completed
Last Updated

February 27, 2007

Status Verified

June 1, 2006

First QC Date

June 1, 2006

Last Update Submit

February 26, 2007

Conditions

HIV

Keywords

HIVTherapeutic vaccine

Outcome Measures

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 (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

  • +2 more secondary outcomes

Interventions

recombinant fowlpoxvirus (rFPV) expressing HIV gag-pol antigensBIOLOGICAL
HIV gag-pol antigens and interferon-gamma (IFN-y)BIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

407 Doctors

Sydney, New South Wales, 2010, Australia

Location

Ground Zero Medical Practice

Sydney, New South Wales, 2010, Australia

Location

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Location

St Vincents Hospital

Sydney, New South Wales, 2010, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Carlton Clinic

Melbourne, Victoria, 3053, Australia

Location

MeSH Terms

Interventions

Interferon-gamma

Intervention Hierarchy (Ancestors)

InterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsMacrophage-Activating FactorsLymphokinesProteinsBiological Factors

Study Officials

  • David A Cooper, AO DSc MD FRACP FRCPA FRCP

    National Centre in HIV Epidemiology and Clinical Research.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 1, 2006

First Posted

June 2, 2006

Study Start

September 1, 2002

Study Completion

September 1, 2003

Last Updated

February 27, 2007

Record last verified: 2006-06

Locations

AU(6)