ITV Extension Study

Study Overview
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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.

Official Title
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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)

Conditions
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HIV

Intervention / Treatment
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* Biological: recombinant fowlpoxvirus (rFPV) expressing HIV gag-pol antigens
* Biological: HIV gag-pol antigens and interferon-gamma (IFN-y)


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: recombinant fowlpoxvirus (rFPV) expressing HIV gag-pol antigens|nan|
|Biological: HIV gag-pol antigens and interferon-gamma (IFN-y)|nan|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Therapeutic vaccine