A Phase 2 interventional study of Recombinant human monoclonal antibody (bNAbs) and Placebo in HIV/AIDS and Infections, sponsored by ANRS, Emerging Infectious Diseases. Recruiting at 17 sites in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by ANRS, Emerging Infectious Diseases · Phase 2, Interventional, and Treatment
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 69 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →ANRS, Emerging Infectious Diseases is the lead sponsor of 212 studies on the registry; 40 are open to participants now.
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Exclusion Criteria:
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).
Drug: Recombinant human monoclonal antibody (bNAbs)
ART plus placebo (saline solution) at HIV-1 primary HIV-1 infection, during 52 weeks minimum, followed by and Antiretroviral Treatment Interruption (ATI).
Drug: Placebo
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.
Also known as: 10-1074-LS and 3BNC117-LS
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.
Also known as: Saline solution
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.
Time frame: at Week 24 of antiretroviral treatment interruption period (ATI)
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
Time frame: from date of inclusion to the last follow-up visit date, up to 148 weeks
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
Time frame: from date of inclusion to the last follow-up visit date, up to 148 weeks
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
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)
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
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)
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)
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
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)
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
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)
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)
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)
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
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
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
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)
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)
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
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)
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)
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
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
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
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.
Time frame: from date of inclusion to the last follow-up visit date, up to 148 weeks
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ANRS, Emerging Infectious Diseases