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RECRUITING
NCT05300035
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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