Clinical trial NCT00332930: ITV Extension 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV
Keywords: HIV
Therapeutic vaccine
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
Collaborators: name: The University of New South Wales
name: Virax Pty. Ltd,
First posted: 2006-06-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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)

Primary outcomes:
measure: Time weighted area under the curve change from plasma HIV-RNA VL at baseline (day 0) until reintroduction of antiretroviral therapy
Secondary outcomes:
measure: Log plasma HIV-RNA load after cessation of combination ART (post-vaccination viral load (VL) set-point)
measure: Kinetics and rate of VL recrudescence and median time to re-initiation of ART
measure: CD8+ T-cell responses to HIV antigens assessed through:
measure: Enzyme linked immunospot (ELISPOT) assay of IFN-y secreting cells
measure: Intracellular Cytokine Cytometry (ICC) for IFN-y and CD69
measure: Human Leucocyte Antigen (HLA) class I/ I matched tetramer analyses for HIV epitope specific CD8+/CD4+ T -cells
measure: CD4+/CD8+ T-cell count changes
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: 407 Doctors
state: New South Wales
city: Sydney
country: Australia
facility: Ground Zero Medical Practice
state: New South Wales
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Sydney
country: Australia
facility: St Vincents Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Carlton Clinic
state: Victoria
Study officials:
affiliation: National Centre in HIV Epidemiology and Clinical Research.
name: David A Cooper, AO DSc MD FRACP FRCPA FRCP
role: PRINCIPAL_INVESTIGATOR
References: