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Phase II Trial of ART + Dual bNAbs vs. ART + Placebo During Primary HIV-1 Infection-impact on Post-ART Control
Sponsor: ANRS, Emerging Infectious Diseases
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.
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.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
69
Start Date
2024-04-11
Completion Date
2028-12-10
Last Updated
2024-12-27
Healthy Volunteers
No
Conditions
Interventions
Recombinant human monoclonal antibody (bNAbs)
1. Initiation of combination ART (1 integrase inhibitor + 2 nucleoside analogue reverse transcriptase inhibitors) with additional dual intravenous infusions of bNAbs (3BNC117LS \& 10-1074LS) between Day 7 and Day 10. 2. Analytical treatment interruption (ATI), 52 weeks later, if good immunologic and virologic conditions. 3. During ATI, plasma HIV-1 RNA and CD4 monitoring, for a maximum of 48 weeks. 4. ART resumption, if participant encounters at least one ART resumption criteria.
Placebo
1. Initiation of combination ART (1 integrase inhibitor + 2 nucleoside analogue reverse transcriptase inhibitors) with additional dual intravenous infusions of placebo (saline solution) between Day 7 and Day 10. 2. Analytical treatment interruption (ATI), 52 weeks later, if good immunologic and virologic conditions. 3. During ATI, plasma HIV-1 RNA and CD4 monitoring, for a maximum of 48 weeks. 4. ART resumption, if participant encounters at least one ART resumption criteria.
Locations (17)
Hôpial Avicenne - SMIT
Bobigny, France
Hôpital Antoine Béclère
Clamart, France
Hôpital Beaujon - Service de médecine interne
Clichy, France
CHI Créteil - HdJ
Créteil, France
Hôpital Raymond Poincaré - SMIT
Garches, France
Hôpital Bicêtre - HdJ - Médecine interne
Le Kremlin-Bicêtre, France
Hôpital Hôtel - Dieu
Paris, France
Hôpital Hôtel Dieu - Service d'immunologie clinique
Paris, France
Hôpital Pitié-Salpêtrière - SMIT
Paris, France
Hôpital Lariboisière - Service de médecine interne A
Paris, France
Hôpital Saint- Louis - SMIT
Paris, France
Hôpital Saint-Antoine - SMIT
Paris, France
Hôpital Necker - SMIT
Paris, France
Hôpital Bichat - Claude Bernard - SMIT
Paris, France
Hôpital Tenon - SMIT
Paris, France
Centre médico chirurgical Foch - Suresnes
Suresnes, France
CHI Villeneuve-Saint-Georges - SMIT
Villeneuve-Saint-Georges, France