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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)

Primary Purpose

HIV/AIDS and Infections

Status
Not yet recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Recombinant human monoclonal antibody (bNAbs)
Placebo
Sponsored by
ANRS, Emerging Infectious Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV/AIDS and Infections

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 before ART interruption.

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 (SARS-CoV-2 PCR positive for less than 72 hours) 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...)

Sites / 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

bNAbs

Placebo

Arm Description

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).

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

Outcomes

Primary Outcome Measures

Proportion of participants with plasma HIV-1 RNA below 400 cp/mL 24 weeks following ATI (W24 ATI), in the confirmed absence of ART.
These participants will be considered as post-treatment controllers.

Secondary Outcome Measures

Tolerance of bNAbs infusion : Number of clinical and biological adverse event (AE)
Number of clinical and biological AE during follow-up. Abnormal laboratory values will be identified as those outside values defined by the DAIDS scale
Tolerance of bNAbs infusion : Nature and Grade of clinical and biological AE
Grade of clinical and biological adverse during follow-up. The intensity of all AE (serious and non-serious) will be graded using the DAIDS AE Grading Table Corrected Version 2.1-July 2017
Tolerance of bNAbs infusion : Time of clinical and biological adverse event (AE)
Proportion of participants resuming ART within the first 24 weeks of ART interruption, according to the reason for resuming.
Time to potential ART resumption for non-controllers.
Clinical and immulogical criteria during follow-up: Proportion of participants with clinical symptoms.
Clinical and immulogical criteria during follow-up: Evolution of CD4, CD8 (levels and %) and CD4/CD8 ratio.
Clinical and immulogical criteria during follow-up: Evolution of inflammation markers levels.
physiological parameters levels will be studied: IP10, TGFβ, IL-7, IL-10, IL-12, IL-15, IL-18, Citrulline, sCD14, sCD163, TNF-α
Immulogical criteria : Changes in the magnitude and quality of HIV-specific T cell responses and humoral responses.
physiological parameters levels will be studied: frequency and functionality of T cells responding to HIV peptides measured by intracellular cytokine staining, surface expression of activation and differentiation markers, HIV suppressive capacity upon co-culture with autologous infected cells
Virological criteria during follow-up: Plasma HIV-1 RNA and HIV-1 DNA level and cell-associated HIV RNA transcripts changes.
Virological criteria : Proportion of participant with plasma HIV-1 RNA < 50 cp/mL at 12- and 24-weeks following ART interruption.
Virological criteria : Cumulative plasma viremia during ART interruption.
Virological criteria : in case of ART resumption, time from date of ART interruption begining to date of first HIV-1 RNA ≥ 50 copies/mL
Virological criteria : in case of ART resumption, proportion of participant with plasma HIV-1 RNA < 50 copies/mL within 24 weeks of ATI.
Virological criteria : Evolution of total HIV-1 DNA and cell-associated HIV-1 RNA by US q-PCR and predictive value on post- ART interruption evolution.
Virological criteria : Evolution of detection proportion and level of cell-associated HIV-1 RNA.
Virological criteria : Qualitative and quantitative changes in the persistent viral reservoir.
physiological parameters levels will be studied: total cell associated HIV-DNA, integrated HIV-DNA, proportion of replication competent vs defective proviruses
Dosages of bNAbs performed during follow-up.
Criteria related to the risk of HIV-1 transmission : Proportion of participants reporting to use condoms during sexual intercourses
Criteria related to the risk of HIV-1 transmission : Proportion of participants reporting to have proposed PrEP at their partners.
Social sciences criteria : Proportion of patients satisfied with their participation and the associated factors
Social sciences criteria : Impact of the participation in the trial on participant quality of life and quality of sexual life
Through statistical analyses of some self-administered questionnaires items (in particular the SF12.v2 scale for quality of life) and thematic analyses of semi-directive individual interviews we will highlight the impact of the participation in the trial.

Full Information

First Posted
January 3, 2022
Last Updated
August 9, 2023
Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Rockefeller University, Institut Pasteur
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1. Study Identification

Unique Protocol Identification Number
NCT05300035
Brief Title
Phase II Trial of ART + Dual bNAbs vs. ART + Placebo During Primary HIV-1 Infection-impact on Post-ART Control
Acronym
RHIVIERA-02
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Rockefeller University, Institut Pasteur

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS and Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
69 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bNAbs
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
ART plus placebo (saline solution) at HIV-1 primary HIV-1 infection, during 52 weeks minimum, followed by and Antiretroviral Treatment Interruption (ATI).
Intervention Type
Drug
Intervention Name(s)
Recombinant human monoclonal antibody (bNAbs)
Other Intervention Name(s)
10-1074-LS and 3BNC117-LS
Intervention Description
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. Analytical treatment interruption (ATI), 52 weeks later, if good immunologic and virologic conditions. During ATI, plasma HIV-1 RNA and CD4 monitoring, for a maximum of 48 weeks. ART resumption, if participant encounters at least one ART resumption criteria.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline solution
Intervention Description
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. Analytical treatment interruption (ATI), 52 weeks later, if good immunologic and virologic conditions. During ATI, plasma HIV-1 RNA and CD4 monitoring, for a maximum of 48 weeks. ART resumption, if participant encounters at least one ART resumption criteria.
Primary Outcome Measure Information:
Title
Proportion of participants with plasma HIV-1 RNA below 400 cp/mL 24 weeks following ATI (W24 ATI), in the confirmed absence of ART.
Description
These participants will be considered as post-treatment controllers.
Time Frame
at Week 24 of antiretroviral treatment interruption period (ATI)
Secondary Outcome Measure Information:
Title
Tolerance of bNAbs infusion : Number of clinical and biological adverse event (AE)
Description
Number of clinical and biological AE during follow-up. Abnormal laboratory values will be identified as those outside values defined by the DAIDS scale
Time Frame
from date of inclusion to the last follow-up visit date, up to 148 weeks
Title
Tolerance of bNAbs infusion : Nature and Grade of clinical and biological AE
Description
Grade of clinical and biological adverse during follow-up. The intensity of all AE (serious and non-serious) will be graded using the DAIDS AE Grading Table Corrected Version 2.1-July 2017
Time Frame
from date of inclusion to the last follow-up visit date, up to 148 weeks
Title
Tolerance of bNAbs infusion : Time of clinical and biological adverse event (AE)
Time Frame
from date of inclusion to the last follow-up visit date, up to 148 weeks
Title
Proportion of participants resuming ART within the first 24 weeks of ART interruption, according to the reason for resuming.
Time Frame
at Week 24 of antiretroviral treatment interruption period (ATI)
Title
Time to potential ART resumption for non-controllers.
Time Frame
from Day 0 of antiretroviral treatment interruption period (ATI) to Day 0 of ART resumption date, assessed up to 48 weeks following ATI
Title
Clinical and immulogical criteria during follow-up: Proportion of participants with clinical symptoms.
Time Frame
during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Title
Clinical and immulogical criteria during follow-up: Evolution of CD4, CD8 (levels and %) and CD4/CD8 ratio.
Time Frame
during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Title
Clinical and immulogical criteria during follow-up: Evolution of inflammation markers levels.
Description
physiological parameters levels will be studied: IP10, TGFβ, IL-7, IL-10, IL-12, IL-15, IL-18, Citrulline, sCD14, sCD163, TNF-α
Time Frame
biological parameters levels during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Title
Immulogical criteria : Changes in the magnitude and quality of HIV-specific T cell responses and humoral responses.
Description
physiological parameters levels will be studied: frequency and functionality of T cells responding to HIV peptides measured by intracellular cytokine staining, surface expression of activation and differentiation markers, HIV suppressive capacity upon co-culture with autologous infected cells
Time Frame
physiological parameters levels during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Title
Virological criteria during follow-up: Plasma HIV-1 RNA and HIV-1 DNA level and cell-associated HIV RNA transcripts changes.
Time Frame
during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Title
Virological criteria : Proportion of participant with plasma HIV-1 RNA < 50 cp/mL at 12- and 24-weeks following ART interruption.
Time Frame
at Week 12 and Week 24 of antiretroviral treatment interruption period (ATI)
Title
Virological criteria : Cumulative plasma viremia during ART interruption.
Time Frame
from Day 0 of antiretroviral treatment interruption period (ATI) to Day 0 of ART resumption, assessed up to 48 weeks following ATI
Title
Virological criteria : in case of ART resumption, time from date of ART interruption begining to date of first HIV-1 RNA ≥ 50 copies/mL
Time Frame
from Day 0 of antiretroviral treatment interruption period (ATI) to Day 0 of ART resumption, assessed up to 48 weeks following ATI
Title
Virological criteria : in case of ART resumption, proportion of participant with plasma HIV-1 RNA < 50 copies/mL within 24 weeks of ATI.
Time Frame
from Day 0 of antiretroviral treatment interruption period (ATI) to Day 0 of ART resumption, assessed up to 48 weeks following ATI
Title
Virological criteria : Evolution of total HIV-1 DNA and cell-associated HIV-1 RNA by US q-PCR and predictive value on post- ART interruption evolution.
Time Frame
during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Title
Virological criteria : Evolution of detection proportion and level of cell-associated HIV-1 RNA.
Time Frame
during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Title
Virological criteria : Qualitative and quantitative changes in the persistent viral reservoir.
Description
physiological parameters levels will be studied: total cell associated HIV-DNA, integrated HIV-DNA, proportion of replication competent vs defective proviruses
Time Frame
physiological parameters levels during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Title
Dosages of bNAbs performed during follow-up.
Time Frame
during ART follow-up (Week 1,Week 12, Week 24, Week 36), and antiretroviral treatment interruption period (Day 0, Week 12, Week 24)
Title
Criteria related to the risk of HIV-1 transmission : Proportion of participants reporting to use condoms during sexual intercourses
Time Frame
from date of inclusion to the last follow-up visit date, up to 148 weeks
Title
Criteria related to the risk of HIV-1 transmission : Proportion of participants reporting to have proposed PrEP at their partners.
Time Frame
from date of inclusion to the last follow-up visit date, up to 148 weeks
Title
Social sciences criteria : Proportion of patients satisfied with their participation and the associated factors
Time Frame
from date of inclusion to the last follow-up visit date, up to 148 weeks
Title
Social sciences criteria : Impact of the participation in the trial on participant quality of life and quality of sexual life
Description
Through statistical analyses of some self-administered questionnaires items (in particular the SF12.v2 scale for quality of life) and thematic analyses of semi-directive individual interviews we will highlight the impact of the participation in the trial.
Time Frame
from date of inclusion to the last follow-up visit date, up to 148 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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...)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathilde Ghislain, MSc
Phone
+331 45 59 52 29
Email
mathilde.ghislain@inserm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Leturque, MSc
Phone
+331 45 59 51 93
Email
nicolas.leturque@inserm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cécile Goujard, Pr
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpial Avicenne - SMIT
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lalla Traore
Email
lalla.traore@aphp.fr
First Name & Middle Initial & Last Name & Degree
Olivier Bouchaud
Facility Name
Hôpital Antoine Béclère
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandrine Poirier
Email
sandrine.poirier@aphp.fr
First Name & Middle Initial & Last Name & Degree
Sophie Abgrall
Facility Name
Hôpital Beaujon - Service de médecine interne
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdelmoula Becharef
Email
abdelmoula.becharef@aphp.fr
First Name & Middle Initial & Last Name & Degree
Agnès Villemant Ululag
Facility Name
CHI Créteil - HdJ
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Richier
Email
laurent.richier@chicreteil.fr
First Name & Middle Initial & Last Name & Degree
Valérie Garrait
Facility Name
Hôpital Raymond Poincaré - SMIT
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rezak Mahrez
Email
rezak.mahrez@aphp.fr
First Name & Middle Initial & Last Name & Degree
Pierre De Truchis
Facility Name
Hôpital Bicêtre - HdJ - Médecine interne
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94275
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain-Serge Keita
Email
alain-serge.keita@aphp.fr
First Name & Middle Initial & Last Name & Degree
Cécile Goujard
Facility Name
Hôpital Hôtel - Dieu
City
Paris
ZIP/Postal Code
75004
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myriam Kalambay
Email
myriam.kalambaykunda@aphp.fr
First Name & Middle Initial & Last Name & Degree
Jean-Paul Viard
Facility Name
Hôpital Hôtel Dieu - Service d'immunologie clinique
City
Paris
ZIP/Postal Code
75004
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Rachline
Email
anne.rachline@aphp.fr
First Name & Middle Initial & Last Name & Degree
Laurence Weiss
Facility Name
Hôpital Pitié-Salpêtrière - SMIT
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasmine Dudoit
Email
yasmine.dudoit@aphp.fr
First Name & Middle Initial & Last Name & Degree
Ludovic Lenclume
Email
ludovic.lenclume@aphp.fr
First Name & Middle Initial & Last Name & Degree
Christine Katlama
Facility Name
Hôpital Lariboisière - Service de médecine interne A
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maguy Parrinello
Email
maguy.parrinello@aphp.fr
First Name & Middle Initial & Last Name & Degree
Agathe Rami
Facility Name
Hôpital Saint- Louis - SMIT
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cylia Imekhlaf
Email
cylia.imekhlaf@aphp.fr
First Name & Middle Initial & Last Name & Degree
Jean-Michel Molina
Facility Name
Hôpital Saint-Antoine - SMIT
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bénédicte Lefebvre
Email
benedicte.lefebvre2@aphp.fr
First Name & Middle Initial & Last Name & Degree
Julie Lamarque
Email
julie.lamarque@aphp.fr
First Name & Middle Initial & Last Name & Degree
Karine Lacombe
Facility Name
Hôpital Necker - SMIT
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carole Louisin
Email
carole.louisin@aphp.fr
First Name & Middle Initial & Last Name & Degree
Claudine Duvivier
Facility Name
Hôpital Bichat - Claude Bernard - SMIT
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynda Chalal
Email
lynda.chalal@aphp.fr
First Name & Middle Initial & Last Name & Degree
Jade Ghosn
Facility Name
Hôpital Tenon - SMIT
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mouniya Mebarki
Email
mouniya.mebarki@aphp.fr
First Name & Middle Initial & Last Name & Degree
Christia Palacios
Email
christia.palacios@aphp.fr
First Name & Middle Initial & Last Name & Degree
Gilles Pialloux
Facility Name
Centre médico chirurgical Foch - Suresnes
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amina Fadli
Email
a.fadli@hopital-foch.com
First Name & Middle Initial & Last Name & Degree
David Zucman
Facility Name
CHI Villeneuve-Saint-Georges - SMIT
City
Villeneuve-Saint-Georges
ZIP/Postal Code
94195
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Richier
Email
laurent.richier@chiv.fr
First Name & Middle Initial & Last Name & Degree
Pauline Caraux Paz

12. IPD Sharing Statement

Learn more about this trial

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

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