ANRS 175 RHIVIERA-01

Rationale of the RHIVIERA-01 study

Based on the results from the ANRS iVISCONTI study and the ANRS CO6 PRIMO cohort, the hypothesis is that HIV-infected patients who initiate antiretroviral therapy (ART) during primary HIV-1 infection and are carriers of the B35 (B53) Bw4TTC2 genotype have an increased ability to control HIV after treatment cessation.

Rhiviera-01 helps to explore this possibility in a proof-of-concept, treatment interruption, non-randomised, prospective, multicentre, national pilot trial.

Methodology

Main objectives of the RHIVIERA-01 study   

• To assess the probability of control of HIV infection (defined by a viral load (VL) of <400 cp/mL), after ART interruption in early-treated ANRS CO6 PRIMO cohort participants with the MHC B35 (B53) Bw4TTC2 genotype   

Primary endpoint

• Percentage of post-treatment controllers (PTC), 6 months after treatment cessation (plasma HIV-RNA <400 cp/mL at S24 (no restart)).

Main inclusion criteria

• 18 years of age or older at the time of consent.
• Participant enrolled and still followed in a site of the ANRS CO6 PRIMO cohort.
• Carrier of the MHC genotype: at least one HLA B35 or B53 allele AND one HLA-A or B allelecarrying the Bw4 epitope AND homozygous -21T residue in the HLA-B alleles ANDheterozygous or homozygous for C2 epitope-carrying HLA-C alleles.
• Treated with combined antiretroviral therapy (cART) within 3 months following inclusion in ANRS CO6 Primo Cohort during at least 18 months and cART not modified in the last 3 months
• Controlled on cART: >90% of VL below 50 cp/mL after initial virological response.
• All VL below 50 cp/mL during the previous 12 months.
• Most recent CD4 measurement on cART above 500 cells/mm3