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

PHASE2RecruitingINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

April 11, 2024

Primary Completion Date

December 10, 2026

Study Completion Date

December 10, 2028

Conditions
HIV/AIDS and Infections
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."

Trial Locations (17)

75004

RECRUITING

Hôpital Hôtel - Dieu, Paris

NOT_YET_RECRUITING

Hôpital Hôtel Dieu - Service d'immunologie clinique, Paris

75013

RECRUITING

Hôpital Pitié-Salpêtrière - SMIT, Paris

75475

RECRUITING

Hôpital Lariboisière - Service de médecine interne A, Paris

RECRUITING

Hôpital Saint- Louis - SMIT, Paris

75571

RECRUITING

Hôpital Saint-Antoine - SMIT, Paris

75743

RECRUITING

Hôpital Necker - SMIT, Paris

75877

RECRUITING

Hôpital Bichat - Claude Bernard - SMIT, Paris

75970

RECRUITING

Hôpital Tenon - SMIT, Paris

92110

RECRUITING

Hôpital Beaujon - Service de médecine interne, Clichy

92140

RECRUITING

Hôpital Antoine Béclère, Clamart

92151

RECRUITING

Centre médico chirurgical Foch - Suresnes, Suresnes

92380

RECRUITING

Hôpital Raymond Poincaré - SMIT, Garches

93000

RECRUITING

Hôpial Avicenne - SMIT, Bobigny

94010

RECRUITING

CHI Créteil - HdJ, Créteil

94195

RECRUITING

CHI Villeneuve-Saint-Georges - SMIT, Villeneuve-Saint-Georges

94275

RECRUITING

Hôpital Bicêtre - HdJ - Médecine interne, Le Kremlin-Bicêtre

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Rockefeller University

OTHER

collaborator

Institut Pasteur

INDUSTRY

lead

ANRS, Emerging Infectious Diseases

OTHER_GOV