biostudies-literatureCrowell TANational Institute of Allergy and Infectious DiseasesCCR NIH HHSIntramural Research Program of the US National Institute of Allergy and Infectious Diseases and the Delaney AIDS Research EnterpriseUS National Cancer InstituteNIAID NIH HHSNCI NIH HHSe297-e306https://www.ebi.ac.uk/biostudies/studies/S-EPMC6693657biostudies-literatureUnknown6(5)<h4>Background</h4>HIV-1-specific broadly neutralising antibodies such as VRC01 could promote HIV remission by halting viral replication and clearing infected cells. We investigated whether VRC01 could promote sustained viral control off antiretroviral therapy (ART) in adults who initiated ART during acute HIV infection.<h4>Methods</h4>We did a randomised, double-blind, placebo-controlled trial at the Thai Red Cross AIDS Research Centre in Bangkok, Thailand. Eligible participants were aged 20-50 years, had initiated ART during acute infection (ie, Fiebig stages I-III), had been taking ART for more than 24 months, had fewer than 50 HIV-1 RNA copies per mL on three consecutive measurements, had more than 400 CD4 cells per μL, had fewer than ten copies of integrated HIV-1 DNA per 10<sup>6</suThe lancet. HIVSafety and efficacy of VRC01 broadly neutralising antibodies in adults with acutely treated HIV (RV397): a phase 2, randomised, double-blind, placebo-controlled trial.PMC66936571U19AI096109HHSN261200800001ER01 AI108433HHSN261200800001CR01AI108433U19 AI096109L30 AI120129Cale ESirivichayakul SMilazzo MPatel BSanders-Buell EManasnayakorn SFullmer BATovanabutra STrautmann LSchuetz Ade Souza MSChan POuellette MPhanuphak NBose MPhanuphak PNuntapinit BChomchey NColby DJAnanworanich JChomont NWattanaboonyongcharoen PSacdalan CDawson PO'Connell RJTrichavaroj RUbolyam SMcDermott ABPagliuzza ALedgerwood JETakata HPaquin-Proulx DShangguan STokarev AKroon EJongsakul KPinyakorn SDoria-Rose NRolland MGrandin PVBenjapornpong KRV397 Study GroupYamchuenpong TVasan SJongrakthaitae SOn KChanthaburanun SThomas RSangnoi NDumrongpisutikul NBailer RTAke JATragonlugsana NEller MAAkapirat SCrowell TATangnaree KGraham BSTressler RChurikanont NGetchalarat SModjarrad KMascola JRLerdlum SIntasan JRobb MLMcCullough CKrebs SJBolton DLMichael NLGorelick RJfalseSafety and efficacy of VRC01 broadly neutralising antibodies in adults with acutely treated HIV (RV397): a phase 2, randomised, double-blind, placebo-controlled trial.<h4>Background</h4>HIV-1-specific broadly neutralising antibodies such as VRC01 could promote HIV remission by halting viral replication and clearing infected cells. We investigated whether VRC01 could promote sustained viral control off antiretroviral therapy (ART) in adults who initiated ART during acute HIV infection.<h4>Methods</h4>We did a randomised, double-blind, placebo-controlled trial at the Thai Red Cross AIDS Research Centre in Bangkok, Thailand. Eligible participants were aged 20-50 years, had initiated ART during acute infection (ie, Fiebig stages I-III), had been taking ART for more than 24 months, had fewer than 50 HIV-1 RNA copies per mL on three consecutive measurements, had more than 400 CD4 cells per μL, had fewer than ten copies of integrated HIV-1 DNA per 10<sup>6</su2019-01-01T00:00:00Z2019 May2026-05-01T03:26:52.62Z2020-10-29T11:58:33ZS-EPMC66936573100047710.1016/S2352-3018(19)30053-010.1016/s2352-3018(19)30053-0