ITV Extension Study

HIV Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332930
• Other study ID #: VIR-NCHR-02
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 1, 2006
• Last updated: February 26, 2007
• Start date: September 2002
• Est. completion date: September 2003

Study information

• Verified date: June 2006
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

Intervention

Biological:
• recombinant fowlpoxvirus (rFPV) expressing HIV gag-pol antigens

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

Locations

Country	Name	City	State
Australia	Carlton Clinic	Melbourne	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	407 Doctors	Sydney	New South Wales
Australia	Ground Zero Medical Practice	Sydney	New South Wales
Australia	Holdsworth House Medical Practice	Sydney	New South Wales
Australia	St Vincents Hospital	Sydney	New South Wales

Sponsors (3)

Lead Sponsor	Collaborator
Kirby Institute	The University of New South Wales, Virax Pty. Ltd,

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time weighted area under the curve change from plasma HIV-RNA VL at baseline (day 0) until reintroduction of antiretroviral therapy
Secondary	Log plasma HIV-RNA load after cessation of combination ART (post-vaccination viral load (VL) set-point)
Secondary	Kinetics and rate of VL recrudescence and median time to re-initiation of ART
Secondary	CD8+ T-cell responses to HIV antigens assessed through:
Secondary	Enzyme linked immunospot (ELISPOT) assay of IFN-y secreting cells
Secondary	Intracellular Cytokine Cytometry (ICC) for IFN-y and CD69
Secondary	Human Leucocyte Antigen (HLA) class I/ I matched tetramer analyses for HIV epitope specific CD8+/CD4+ T –cells
Secondary	CD4+/CD8+ T-cell count changes

External Links

•   (National Centre in HIV Epidemiology and Clinical Research Homepage)