2018
Phase 3 Study of Ibalizumab for Multidrug-Resistant HIV-1
Emu B, Fessel J, Schrader S, Kumar P, Richmond G, Win S, Weinheimer S, Marsolais C, Lewis S. Phase 3 Study of Ibalizumab for Multidrug-Resistant HIV-1. New England Journal Of Medicine 2018, 379: 645-654. PMID: 30110589, DOI: 10.1056/nejmoa1711460.Peer-Reviewed Original ResearchConceptsPhase 3 studyHIV-1 infectionViral loadBackground regimenVirologic failureAdverse eventsWeek 25Multidrug-resistant HIV-1 infectionMDR HIV-1 infectionMean baseline viral loadMultidrug-resistant HIV-1Human immunodeficiency virus type 1Immunodeficiency virus type 1Control periodMultiple antiretroviral therapiesViral load decreaseCommon adverse eventsMean CD4 countPrimary end pointSerious adverse eventsBaseline viral loadProportion of patientsHIV-1 RNALimited treatment optionsVirus type 1
2017
Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of RG7667, a Combination Monoclonal Antibody, for Prevention of Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients
Ishida JH, Patel A, Mehta AK, Gatault P, McBride JM, Burgess T, Derby MA, Snydman DR, Emu B, Feierbach B, Fouts AE, Maia M, Deng R, Rosenberger CM, Gennaro LA, Striano NS, Liao XC, Tavel JA. Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of RG7667, a Combination Monoclonal Antibody, for Prevention of Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients. Antimicrobial Agents And Chemotherapy 2017, 61: 10.1128/aac.01794-16. PMID: 27872061, PMCID: PMC5278717, DOI: 10.1128/aac.01794-16.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalCytomegalovirus InfectionsFemaleHumansKidney TransplantationMaleMiddle AgedPlacebosTreatment OutcomeViremiaConceptsHigh-risk kidney transplant recipientsKidney transplant recipientsCMV viremiaTransplant recipientsCMV diseaseCMV infectionCytomegalovirus infectionMonoclonal antibodiesCMV-seronegative recipientsCMV-seropositive donorsLess CMV diseasePlacebo-controlled trialTime of transplantKidney transplantationPlacebo groupAdverse eventsKidney transplantMedian timeSignificant complicationsPlaceboTreatment groupsPatientsViremiaInfectionWeeks
2015
Phase 1 Randomized, Double-Blind, Placebo-Controlled Study of RG7667, an Anticytomegalovirus Combination Monoclonal Antibody Therapy, in Healthy Adults
Ishida JH, Burgess T, Derby MA, Brown PA, Maia M, Deng R, Emu B, Feierbach B, Fouts AE, Liao XC, Tavel JA. Phase 1 Randomized, Double-Blind, Placebo-Controlled Study of RG7667, an Anticytomegalovirus Combination Monoclonal Antibody Therapy, in Healthy Adults. Antimicrobial Agents And Chemotherapy 2015, 59: 4919-4929. PMID: 26055360, PMCID: PMC4505204, DOI: 10.1128/aac.00523-15.Peer-Reviewed Original ResearchConceptsHealthy adultsPlacebo groupAdverse eventsMonoclonal antibodiesDose-proportional pharmacokineticsMost adverse eventsDose-escalation studyMonoclonal antibody therapyProportion of subjectsHuman monoclonal antibodyOverall pharmacokinetic profileLife-threatening diseasePhase 1Transplant recipientsCytomegalovirus infectionAntibody therapyImmunogenicity profileMultiple dosesAntibody responseImmunocompromised individualsPharmacokinetic profileSusceptible populationAdultsHost targetsTherapy