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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-11

Study Completion Date

2028-12-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV/AIDS and Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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bNAbs

ART plus dual long-acting (LS) broadly neutralising antibodies (bNAbs) infusion at HIV-1 primary HIV-1 infection, during 52 weeks minimum, followed by and Antiretroviral Treatment Interruption (ATI).

Group Type ACTIVE_COMPARATOR

Recombinant human monoclonal antibody (bNAbs)

Intervention Type DRUG

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

ART plus placebo (saline solution) at HIV-1 primary HIV-1 infection, during 52 weeks minimum, followed by and Antiretroviral Treatment Interruption (ATI).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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10-1074-LS and 3BNC117-LS Saline solution

Eligibility Criteria

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Inclusion Criteria

* Confirmed primary HIV-1 infection diagnostic
* Aged ≥18 to ≤70 years old at screening
* Willing to use use an effective method of contraception from the inclusion until the end of the follow-up in the trial
* Negative plasmatic beta human chorionic gonadotropin (β-HCG) pregnancy test, when applicable
* Agree not to seek pregnancy including through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit, when applicable
* Informed and written signed consent
* Participant with regular health insurance
* Willing to accept the trial constraints (travel for IMP administration and ART interruption)
* Willing to be vaccinated against COVID-19 according to recommandations

Exclusion Criteria

* Participation in any other clinical trial requiring additional blood sampling Participation in an observational study without additional blood sampling is permitted
* Participants in whom condom use or PrEP use by the partner will be difficult or impossible
* Pregnant or breastfeeding patient
* Participants under guardianship or curatorship
* Any condition or infection, including HCV, HBV, SARS-CoV-2 or known M. tuberculosis active infection History of ischemic heart disease (myocardial infarction, stable or unstable angina, stroke)
* Current or past history of cancer, excluding squamous cell skin cancers
* History or acute known inflammatory ophthalmic affection (uveitis, choroiditis, optic neuropathy)
* Any medical condition that contraindicates ART interruption
* Concomitant or previous conditions that preclude injection of monoclonal antibodies
* History of systemic corticosteroids, immunosuppressive and anti-cancer medications within the last 6 months
* History of severe reaction to a vaccine or drug infusion or history of severe allergic reactions
* Individuals with any contraindication (including hypersensitivity reaction) to 3BNC117-LS and 10-1074-LS infusion
* Prothrombin \< 50%
* Creatinine clearance \< 60mL/mn (Cockroft)
* ASAT or ALAT or bilirubine (total et conjugated) ≥ 10 times the upper limit of normal
* Patient with an isolated HIV-2 viral strain
* Planned absence that could affect participation in the trial (travel abroad, relocation, impending transfer...)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cécile Goujard, Pr

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

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Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

bNAbs

Recombinant human monoclonal antibody (bNAbs)

Placebo

Placebo

Interventions

Recombinant human monoclonal antibody (bNAbs)

Placebo

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Rockefeller University

Institut Pasteur

ANRS, Emerging Infectious Diseases

Responsible Party

Principal Investigators

Cécile Goujard, Pr

Locations

Hôpial Avicenne - SMIT

Hôpital Antoine Béclère

Hôpital Beaujon - Service de médecine interne

CHI Créteil - HdJ

Hôpital Raymond Poincaré - SMIT

Hôpital Bicêtre - HdJ - Médecine interne

Hôpital Hôtel - Dieu

Hôpital Hôtel Dieu - Service d'immunologie clinique

Hôpital Pitié-Salpêtrière - SMIT

Hôpital Lariboisière - Service de médecine interne A

Hôpital Saint- Louis - SMIT

Hôpital Saint-Antoine - SMIT

Hôpital Necker - SMIT

Hôpital Bichat - Claude Bernard - SMIT

Hôpital Tenon - SMIT

Centre médico chirurgical Foch - Suresnes

CHI Villeneuve-Saint-Georges - SMIT

Countries

Central Contacts

Mathilde Ghislain, MSc

Nicolas Leturque, MSc

Facility Contacts

Brigitte Gbaguidi

Sandrine Poirier

Abdelmoula Becharef

Laurent Richier

Rezak Mahrez

Véronique Godard

Marie-Josée Dulucq

Anne Rachline

Yasmine Dudoit

Naima Hamani

Guylaine Alexandre

Cylia Imekhlaf

Bénédicte Lefebvre

Julie Lamarque

Carole Louisin

Lynda Chalal

Pelagie Thibaut

Christia Palacios

Amina Fadli

Laurent Richier

Other Identifiers

ANRS 176 RHIVIERA-02