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

HIV

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).

Tolerability of intravenous infusions of bNAbs: number, grade, reason and time of clinical and biological adverse event (AE): o During ART, o During overall follow-up,, Proportion of participants resuming ART within the first 24 weeks of ATI, according to the reason for resuming;, Time to potential ART resumption for non-controllers;, Clinical and immulogical criteria, during ART (D0 to W52ARV (or W64ARV 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, Virological criteria : o Plasma HIV-1 RNA and HIV-1 DNA level and cell-associated HIV RNA transcripts changes during ART (D0 to W52ARV (or W64ARV or W76ARV)), ATI (from D0ATI) and potential ART resumption (from D0Res to W24Res), o Proportion of participant with plasma HIV-1 RNA < 50 cp/mL at 12- and 24-weeks following ATI, o Cumulative plasma viremia during ATI,, Virological criteria : o 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, o Evolution of total HIV-1 DNA and cell-associated HIV-1 RNA by US q-PCR and predictive value on post-ATI evolution, o Evolution of detection proportion and level of cell-associated HIV-1 RNA, oQualitative and quantitative changes in the persistent viral reservoir, Virological criteria :Evolution of total HIV-1 DNA and cell-associated HIV-1 RNA by US q-PCR and predictive value on post-ATI evolution, o Evolution of detection proportion and level of cell-associated HIV-1 RNA, o Qualitative and quantitative changes in the persistent viral reservoir,, Immunological criteria : o Changes in the magnitude and quality of HIV-specific T cell responses and humoral responses after infusions of bNAbs (W1ARV) and after ATI,, Pharmacological criteria : o Dosages of bNAbs performed after infusions (D0 to end of ATI period), o Dosages of ARV drugs performed during ATI (D0ATI to W24ATI)),, Criteria related to the risk of HIV-1 transmission: o Proportion of participants reporting to use condoms during sexual intercourse during follow-up, o Proportion of participants reporting to have proposed PrEP at their partners during ATI during follow-up,, Social sciences criteria : o Proportion of patients satisfied with their participation and the associated factors, o Impact of the participation in the trial on participant quality of life and quality of sexual life.

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