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    Summary
    EudraCT Number:2021-003040-25
    Sponsor's Protocol Code Number:ANRS176
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-10-28
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2021-003040-25
    A.3Full title of the trial
    A randomised phase II placebo-controlled trial of 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.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised phase II placebo-controlled trial of 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.
    A.3.2Name or abbreviated title of the trial where available
    RHIVIERA-02
    A.4.1Sponsor's protocol code numberANRS176
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInserm-ANRS
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportANRS|Maladies infectieuses émergentes
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInserm-ANRS
    B.5.2Functional name of contact pointLaura Nailler
    B.5.3 Address:
    B.5.3.1Street Address2, rue d'Oradour-Sur-Glane
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75015
    B.5.3.4CountryFrance
    B.5.4Telephone number331 53 94 80 64
    B.5.6E-mailcdp.clinique@anrs.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name3BNC117-LS
    D.3.2Product code 3BNC117-LS
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor code3BNC117-LS
    D.3.9.3Other descriptive name3BNC117-LS
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name10-1074-L-S
    D.3.2Product code 10-1074-L-S
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor code10-1074-LS
    D.3.9.3Other descriptive name10-1074-LS
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name CHLORURE DE SODIUM FRESENIUS 0,9 %
    D.2.1.1.2Name of the Marketing Authorisation holderFRESENIUS KABI FRANCE SA
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium chloride
    D.3.9.2Current sponsor codeChlorure de Sodium
    D.3.9.3Other descriptive nameNacL
    D.3.9.4EV Substance CodeSUB12581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HIV infection
    E.1.1.1Medical condition in easily understood language
    HIV infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10020161
    E.1.2Term HIV infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate if the administration of a treatment consisting of dual long-acting HIV-specific broadly neutralizing antibodies (3BNC117-LS & 10-1074-LS (bNAbs)), in combination with an antiretroviral therapy (ART) in individuals with primary HIV-1 infection (PI) when compared to ART only (with neutralizing antibodies or placebo) will favour a period of HIV-1 remission when ART is interrupted 52 or 76 weeks later.
    E.2.2Secondary objectives of the trial
    - Evaluate the tolerability of intravenous infusion of bNAbs;

    - After bNAbs infusions and during ART, during analytic treatment interruption (ATI) and after ART resumption for non controller participants:
    o clinical, immunological and virological changes from baseline,
    o activation and inflammatory markers changes from baseline,
    o changes from baseline in the persistent viral reservoir,

    - Baseline factors associated with plasma Viral Load control during ATI;

    - To explore: expectations and motivations related to participation in the clinical trial and their evolution after having experienced such a participation, anticipation and understanding of risks and benefits related to participation, evolution over time of participation experience and of satisfaction with the information delivered, experience and perception of the ATI period, with an emphasis on its impact on prevention behaviours and sexual quality of life, reasons and experience related to refusal of participation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participant with confirmed primary HIV-1 infection (PI) diagnostic, symptomatic or asymptomatic, corresponding to one of the situations bellow:
    o Negative ELISA test (non dissociated test) or ELISA Ac-/p24- and positive HIV-1 RNA (confirmed by a second positive HIV-1 RNA),
    o ELISA test Ac-/p24+ (confirmed by a positive HIV-1 RNA),
    o Positive ELISA test (non dissociated test) or ELISA Ac+/p24+ or ELISA Ac+/p24- and WB-HIV-1 [0-5] bands(s) or IB-HIV-1 [0-3] band(s) (confirmed by a positive HIV-1 RNA).

    Any result achieved in the previous 10 days of inclusion visit will be taken into account.
    - Aged 18 years or more, and less than 70 years, at the time of consent;
    - Participant who accepts the use of an effective method of contraception (see definition on Appendix A8) from the inclusion until the end of the follow-up in the trial (minimum 52 weeks). For men and trans women, his also applies to sperm donation;
    - For women or trans men:
    o negative plasmatic beta human chorionic gonadotropin (β-HCG) pregnancy test,
    o 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,
    - Informed and written signed consent;
    - Participant with regular health insurance (AME is not considered as a regular health insurance);
    - Participant accepting additional constraints and:
    o willing to travel to 1 of the 2 IMP administration centers (between D7ARV and D10ARV),
    o willing to interrupt ART,
    - Agreement to be vaccinated against COVID-19 before ATI.
    E.4Principal exclusion criteria
    - Participation in any other clinical trial of an investigational agent or in any interventional or non-interventional study 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 woman or trans man;
    - 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 neurologic, 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 (CKD-EPI);
    - 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...).
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants with plasma HIV-1 RNA below 400 cp/mL 24 weeks following ATI, in the confirmed absence of ART. These participants will be considered as post-treatment controllers (PTC).
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks following ATI
    E.5.2Secondary end point(s)
    1/ Tolerability of intravenous infusions of bNAbs : number, grade, reason and time of clinical and biological adverse event (AE):
    2/ Proportion of participants resuming ART within the first 24 weeks of ATI, according to the reason for resuming;
    3/ Time to potential ART resumption for non-controllers;
    4/ Clinical and immulogical criteria, during ART (D0 to W52ARV (or W76ARV)), ATI (from D0ATI) and potential ART resumption (from D0Res to W24Res);
    o Proportion of participants with clinical symptoms,
    o Evolution of CD4, CD8 (levels and %) and CD4/CD8 ratio,
    o Evolution of inflammation markers levels.
    5/Virological criteria :
    a/ Plasma HIV-1 RNA and HIV-1 DNA level and cell-associated HIV RNA transcripts changes during ART (D0 to W52ARV (or W76ARV)), ATI (from D0ATI) and potential ART resumption (from D0Res to W24Res),
    b/ Proportion of participant with plasma HIV-1 RNA < 50 cp/mL at 12- and 24-weeks following ATI,
    c/ Cumulative plasma viremia during ATI
    d/ In case of ART resumption :
    - Time from date of ATI begining to date of first VL ≥ 50 copies/mL,
    - Proportion of participant with plasma HIV-1 RNA < 50 copies/mL within 24 weeks of ART
    e/ Evolution of total HIV-1 DNA and cell-associated HIV-1 RNA by US q-PCR and predictive value on post-ATI evolution,
    f/Evolution of detection proportion and level of cell-associated HIV-1 RNA,
    g/Qualitative and quantitative changes in the persistent viral reservoir,

    6/ Immunological criteria : Changes in the magnitude and quality of HIV-specific T cell responses and humoral responses after infusions of bNAbs (W1ARV) and after ATI,

    7/ Pharmacological criteria :
    a/Dosages of bNAbs performed after infusions (D0 to end of ATI period),
    b/ Dosages of ARV drugs performed during ATI (D0IAT to W24IAT),

    8/ Criteria related to the risk of HIV-1 transmission:
    a/Proportion of participants reporting to use condoms during sexual intercourse during follow-up,
    b/Proportion of participants reporting to have proposed PrEP at their partners during ATI during follow-up,

    9/ social science criteria
    a/Proportion of patients satisfied with their participation and the associated factors,
    b/Impact of the participation in the trial on participant quality of life and quality of sexual life
    E.5.2.1Timepoint(s) of evaluation of this end point
    1/ During ART and during overall follow-up
    2/ At 24 weeks of ATI
    3/ from D0ATI until D0Res
    4/ during ART (from D0 to W52ARV (or W76ARV)), during ATI (from D0ATI to D0Res) and potential ART resumption (from D0Res to W24Res);
    5/ a : during ART (from D0 to W52ARV (or W76ARV)), during ATI (from D0ATI to D0Res) and potential ART resumption (from D0Res to W24Res),
    b : at W12- W24 ATI
    c : during ATI (from D0ATI until D0Res)
    d : at D0Res
    e, f, g : During ART, During ATI and in case of ART Resumption, at D0Res, W24Res

    6/ at W1ARV and after ATI,

    7/
    a/ D0 to end of ATI period
    b/ D0IAT to W24IAT

    8/ a/ from D0 until the end of follow-up,
    b/ from D0 until the end of follow-up,

    9/ social science criteria
    a/at the end of follow up
    b/from D0 until the end of follow-up
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned17
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study will be 1 year after LVLS in order to complete
    all virological, immunological and pharmacological analyses
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 59
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The therapeutic management at the end of the trial (or at the time of early termination) will be decided by the investigator, with each participant, based on their immunological and virological results and according to the recommendations in force.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-21
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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