EHVA T02

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EHVA T02 (European HIV Vaccine Alliance Therapeutic Trial) / ANRS VRI07

Design: Multicenter, randomized, double-blind, phase 2
Statutes: Recruitment completed - End of study
Study duration per participant: up to 60 weeks

Study Title: «Randomized Phase II study of vedolizumab with or without therapeutic HIV vaccination (VAM) in people who started antiretroviral therapy during primary or chronic infection.»

The purpose of this study is to evaluate an antibody with or without a therapeutic HIV vaccine (VAM) in people living with HIV and on antiretroviral therapy. The term "therapeutic" here means a product "that may have a benefit" for people living with HIV. This study involves a maximum of 37 visits over a 60-week period. The study is being conducted in 4 phases:

1. Selection of participants
2. Treatment phase of the study (continuation of antiretroviral therapy)
3. Analytical treatment interruption phase (discontinuation of antiretroviral therapy)
4. Resumption of antiretroviral therapy

Each study participant will be randomly assigned to one of three groups to receive either the active products or the placebos.

• Group 1: Vaccine and vedolizumab infusion
• Group 2: Placebo vaccine and vedolizumab infusion
• Group 3: Placebo vaccine and placebo vedolizumab infusion