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ITV Extension Study

NCT ID: NCT00332930

Last Updated: 2007-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2003-09-30

Brief Summary

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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

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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

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HIV

Keywords

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HIV Therapeutic vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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recombinant fowlpoxvirus (rFPV) expressing HIV gag-pol antigens

Intervention Type BIOLOGICAL

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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 Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of New South Wales

OTHER

Sponsor Role collaborator

Virax Pty. Ltd,

INDUSTRY

Sponsor Role collaborator

Kirby Institute

OTHER_GOV

Sponsor Role lead

Principal Investigators

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David A Cooper, AO DSc MD FRACP FRCPA FRCP

Role: PRINCIPAL_INVESTIGATOR

National Centre in HIV Epidemiology and Clinical Research.

Locations

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407 Doctors

Sydney, New South Wales, Australia

Site Status

Ground Zero Medical Practice

Sydney, New South Wales, Australia

Site Status

Holdsworth House Medical Practice

Sydney, New South Wales, Australia

Site Status

St Vincents Hospital

Sydney, New South Wales, Australia

Site Status

The Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Carlton Clinic

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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VIR-NCHR-02

Identifier Type: -

Identifier Source: org_study_id