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.

简要总结

详细描述

主要结局

次要结局

• Proportion of participants resuming ART within the first 24 weeks of ART interruption, according to the reason for resuming.(at Week 24 of antiretroviral treatment interruption period (ATI))
• Time to potential ART resumption for non-controllers.(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.(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 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.(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.(at Week 12 and Week 24 of antiretroviral treatment interruption period (ATI))
• Virological criteria : Cumulative plasma viremia during ART interruption.(from Day 0 of antiretroviral treatment interruption period (ATI) to Day 0 of ART resumption, assessed up to 48 weeks following ATI)
• Tolerance of bNAbs infusion : Number of clinical and biological adverse event (AE)(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(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)(from date of inclusion to the last follow-up visit date, up to 148 weeks)
• Clinical and immulogical criteria during follow-up: Evolution of inflammation markers levels.(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))
• Clinical and immulogical criteria during follow-up: Evolution of CD4, CD8 (levels and %) and CD4/CD8 ratio.(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 : in case of ART resumption, time from date of ART interruption begining to date of first HIV-1 RNA ≥ 50 copies/mL(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.(from Day 0 of antiretroviral treatment interruption period (ATI) to Day 0 of ART resumption, assessed up to 48 weeks following ATI)
• Criteria related to the risk of HIV-1 transmission : Proportion of participants reporting to use condoms during sexual intercourses(from date of inclusion to the last follow-up visit date, up to 148 weeks)
• 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.(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 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.(during ART follow-up (Week 1,Week 12, Week 24, Week 36), and antiretroviral treatment interruption period (Day 0, Week 12, Week 24))
• Virological criteria : Evolution of detection proportion and level of cell-associated HIV-1 RNA.(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))
• Social sciences criteria : Impact of the participation in the trial on participant quality of life and quality of sexual life(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(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.(from date of inclusion to the last follow-up visit date, up to 148 weeks)