EHVA T01(European HIV Vaccine Alliance Therapeutic Trial01)/ANRS VRI05
Research type
Research Study
Full title
EHVA T01(European HIV Vaccine Alliance Therapeutic Trial 01)/ANRS VRI05: A Phase I/II randomised therapeutic HIV vaccine trial in individuals who started antiretrovirals during primary or chronic infection
IRAS ID
219277
Contact name
Marta Boffito
Contact email
Sponsor organisation
INSERM-ANRS
Eudract number
2017-003081-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Antiretroviral HIV treatment (ART) has transformed the survival of people living with HIV. However, ART is life long and there are a number of limitations to the benefits of taking it. The drugs do not cure HIV, they may be associated with side-effects, and some people may find it difficult to take a drug every day for the rest of their life. \nThe development of other approaches to help their immune system control and overcome the HIV virus is a key goal. We believe that therapeutic vaccination has a role to play in this. \nAnother approach is the use of monoclonal antibodies as immunotherapy, i.e. a treatment that improves your immune system. \nThis study will measure: \n•the impact of a prime-boost vaccine regimen (two different vaccines – DNA and MVA) on viral load\n•the impact of immunotherapy (Vedolizumab – a monoclonal antibody) on viral load\n•the impact of combining the prime-boost vaccine regimen with immunotherapy on viral load. \nTo measure the impact of these strategies on viral load, we need to ask people in the study to stop HIV treatment for up to 24 weeks. \nWe are looking to recruit patients in the UK and 5 other European countries who are HIV positive and stable on their current therapy. Participants will be in the study for up to 66 weeks and will receive vaccine or placebo only (2 DNA/1 MVA), monoclonal antibody or placebo only (6 infusions) or a combination of the two.\nThe study is funded under a grant from the European Union’s Horizon 2020 Research and Innovation Programme and also by a grant from the Swiss government. \n
REC name
London - South East Research Ethics Committee
REC reference
17/LO/1716
Date of REC Opinion
19 Feb 2018
REC opinion
Further Information Favourable Opinion