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Phase II Trial of ART + Dual bNAbs vs. ART + Placebo During Primary HIV-1 Infection-impact on Post-ART Control — RHIVIERA-02  

HIV/AIDS and Infections Clinical Trial

Official title:
A Randomised Phase II Placebo-controlled Trial of Antiretroviral Therapy (ART) Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs) vs ART Plus Placebo During Primary HIV-1 Infection to Study the Impact on Post-treatment HIV Control.

Clinical Trial Summary

RHIVIERA-02 trial is a placebo-controlled double-blinded two arm prospective phase II trial. This study will test the use of broadly neutralising antibodies (bNAbs) in participants, at primary HIV infection (PHI) and ART initiation.

Clinical Trial Description

The study proposes to test an intervention consisting of dual long-acting HIV-specific broadly neutralizing antibodies (3BNC117-LS & 10-1074-LS ) + ART, at primary HIV-1 infection, and to compare it to ART only regarding HIV-1 replication. The study aims to enrol 69 participants in French (Ile-de-France) clinical centres. Participants will have been diagnosed with primary HIV-1 infection, will start ART during early phase of Primary HIV infection, and will interrupt ART 52 weeks later. Study duration will vary by participant, depending on the time of ART interruption and the time to viral rebound. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05300035
Study type Interventional
Source ANRS, Emerging Infectious Diseases
Contact Mathilde Ghislain, MSc
Phone +331 45 59 52 29
Email mathilde.ghislain@inserm.fr
Status Recruiting
Phase Phase 2
Start date April 11, 2024
Completion date December 10, 2028
View Details
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