ITV Extension Study - Full Text View

Sponsor:	The National Centre in HIV Epidemiology and Clinical Research
Collaborators:	The University of New South Wales Virax Pty. Ltd,
Information provided by:	The National Centre in HIV Epidemiology and Clinical Research
ClinicalTrials.gov Identifier:	NCT00332930

Purpose

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).

Condition	Intervention	Phase
HIV	Biological: recombinant fowlpoxvirus (rFPV) expressing HIV gag-pol antigens Biological: HIV gag-pol antigens and interferon-gamma (IFN-y)	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy 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)

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Interferon gamma-1b Interferons

U.S. FDA Resources

Further study details as provided by The National Centre in HIV Epidemiology and Clinical Research:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	35
Study Start Date:	September 2002
Estimated Study Completion Date:	September 2003

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332930

Locations

Australia, New South Wales
407 Doctors
Sydney, New South Wales, Australia, 2010
Ground Zero Medical Practice
Sydney, New South Wales, Australia, 2010
Holdsworth House Medical Practice
Sydney, New South Wales, Australia, 2010
St Vincents Hospital
Sydney, New South Wales, Australia, 2010
Australia, Victoria
Carlton Clinic
Melbourne, Victoria, Australia, 3053
The Alfred Hospital
Melbourne, Victoria, Australia, 3004

Sponsors and Collaborators

The National Centre in HIV Epidemiology and Clinical Research

The University of New South Wales

Virax Pty. Ltd,

Investigators

Principal Investigator:

David A Cooper, AO DSc MD FRACP FRCPA FRCP

National Centre in HIV Epidemiology and Clinical Research

More Information

Additional Information:

(National Centre in HIV Epidemiology and Clinical Research Homepage) This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	VIR-NCHR-02
Study First Received:	June 1, 2006
Last Updated:	February 26, 2007
ClinicalTrials.gov Identifier:	NCT00332930 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The National Centre in HIV Epidemiology and Clinical Research:

HIV
Therapeutic vaccine

Additional relevant MeSH terms:

Anti-Infective Agents
Interferon Type II
Antineoplastic Agents
Therapeutic Uses

Antiviral Agents
Pharmacologic Actions
Interferon-gamma, Recombinant

ClinicalTrials.gov processed this record on February 08, 2010