biostudies-literatureLee MJMedical Research CouncilBill and Melinda Gates Foundation263https://www.ebi.ac.uk/biostudies/studies/S-EPMC8981886biostudies-literatureUnknown23(1)<h4>Background</h4>Antiretroviral therapy (ART) has led to dramatic improvements in survival for people living with HIV, but is unable to cure infection, or induce viral control off therapy. Designing intervention trials with novel agents with the potential to confer a period of HIV remission without ART remains a key scientific and community goal. We detail the rationale, design, and outcomes of a randomised, placebo-controlled trial of two HIV-specific long-acting broadly neutralising antibodies (bNAbs): 3BNC117-LS and 10-1074-LS, which target CD4 binding site and V3 loop respectively, on post-treatment viral control.<h4>Methods</h4>RIO is a randomised, placebo-controlled, double-blinded prospective phase II study. Eligible individuals will have started ART within 3 months of primary HIVTrialsThe RIO trial: rationale, design, and the role of community involvement in a randomised placebo-controlled trial of antiretroviral therapy plus dual long-acting HIV-specific broadly neutralising antibodies (bNAbs) in participants diagnosed with recent HIV infection-study protocol for a two-stage randomised phase II trial.PMC8981886MR/L006588/1MR/L00528X/1#OPP1210792Prevost ATJohnson NBox HNussenzweig MCCollins SFrater JAshraf APace MBrown HCaskey MFidler SFalaschetti EZacharopoulou PHurley LOgbe AKhan MJacob MSutherland EFox JCole THorowitz JDeeks SBabalis DLee MJfalseThe RIO trial: rationale, design, and the role of community involvement in a randomised placebo-controlled trial of antiretroviral therapy plus dual long-acting HIV-specific broadly neutralising antibodies (bNAbs) in participants diagnosed with recent HIV infection-study protocol for a two-stage randomised phase II trial.<h4>Background</h4>Antiretroviral therapy (ART) has led to dramatic improvements in survival for people living with HIV, but is unable to cure infection, or induce viral control off therapy. Designing intervention trials with novel agents with the potential to confer a period of HIV remission without ART remains a key scientific and community goal. We detail the rationale, design, and outcomes of a randomised, placebo-controlled trial of two HIV-specific long-acting broadly neutralising antibodies (bNAbs): 3BNC117-LS and 10-1074-LS, which target CD4 binding site and V3 loop respectively, on post-treatment viral control.<h4>Methods</h4>RIO is a randomised, placebo-controlled, double-blinded prospective phase II study. Eligible individuals will have started ART within 3 months of primary HIV2022-01-01T00:00:00Z2022 Apr2026-05-30T23:08:55.18Z2024-11-11T23:30:50.188ZS-EPMC89818863538284410.1186/s13063-022-06151-w