ITV Extension Study

Kirby Institute

Status and phase

Completed

Phase 2

Phase 1

Conditions

HIV

Treatments

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

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

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00332930

VIR-NCHR-02

Details and patient eligibility

About

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).

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)