Table 1 Summary of current or future clinical trials involving bNAbs 3BNC117 or 10-1074 (including long-acting -LS versions)
Clinicaltrials.gov number | Intervention | Study design | PI, Sponsor | Start date | Primary endpoint |
|---|---|---|---|---|---|
NCT03554408 | bNAbs: 10-1074 LS and 3BNC-117 LS, alone and together | Phase I, dose escalation, first in man in HIV-negative and HIV-positive individuals. n = 75 | Caskey, Rockefeller University, USA | Jun 2018 | Safety and tolerability |
NCT03619278 | bNAb: 10-1074, Latency reversal agent (LRA): Romidepsin, Vaccine: HIVACAR01 | Phase I/IIa randomised triple-blind placebo-controlled trial n = 12 | PI: Garcia Cinca, IDIBAPS, Barcelona, Spain | Nov 2020 | Safety |
NCT03588715 BEAT-2 | Peg-IFN-a2b, bNAbs: 3BNC117, 10-1074 | Phase I randomised open-label trial n = 21 | PI: Montaner, University of Pennsylvania, USA | Jun 2020 | Safety Frequency of VL < 50 copies/ml at week 8 after ATI Innate activation |
NCT03041012 eCLEAR | bNAb: 3BNC117, LRA: Romidepsin | Phase I open-label 4-arm randomised controlled trial n = 60 | PI: Søgaard, Aarhus University Hospital, Denmark | Jan 2017 | Time to VL < 20 copies/ml Quantification of proviral HIV reservoir |
NCT03837756 TITAN | TLR9 agonist: Lefitolimod, bNAbs: 3BNC117, 10-1074 | Phase II randomised placebo-controlled double-blinded study n = 48 | PI: Søgaard, Aarhus University Hospital, Denmark | May 2019 | Time to VL > 10 000 copies/ml × 3 or end of ATI |
NCT04357821 | Vaccines: IL-12 adjuvanted p24CE DNA prime, IL-12 adjuvanted DNA boost, MVA/HIV62B boost, bNAbs: VRC07-523LS, 10-1074, TLR9 agonist: Lefitolimod | Phase I/II Single group open-label combination intervention trial n = 20 | PI: Deeks, University of California, USA | Aug 2020 | Safety Proportion achieving post-treatment control |
NCT04408963 | bNAb: CAP256V2LS via intravenous or subcutaneous administration | Phase I Open-label trial n = 20 | PI: Widge, National Institute of Health Clinical Centre, Maryland, USA | Mar 2021 | Safety Tolerability |
NCT03538626 | bNAb: N6LS Recombinant human hyaluronidase (rHuPH20) | Phase I open-label dose-escalation trial n = 40 | PI: Gaudinski, National Institute of Health Clinical Centre, Maryland, USA | Jun 2018 | Safety Tolerability |
NCT04173819 | bNAbs: 3BNC117-LS-J 10-1074-LS-J | Phase I/II Randomised double-blinded placebo-controlled trial n = 225 | PI: Caskey, Rockefeller University, USA | Jan 2019 | Safety Pharmacokinetics |
NCT04560569 | Albuvirtide (long-acting fusion inhibitor) bNAb: 3BNC117 | Phase II open-label non-randomised trial n = 20 | PI: Yao Frontier Biotechnologies Inc., USA | Apr 2021 | Proportion of participants with ≥0.5log reduction in HIV-1 VL from baseline to day 14 |
NCT03571204 | bNAbs: 3BNC117, 10-1074 | Phase I triple-blinded randomised placebo-controlled trial n = 50 | PI: Sneller, National Institutes of Health Clinical Centre, Maryland, USA | Sep 2018 | Safety Tolerability |
NCT04250636 | bNAbs: 3BNC117-LS, 10-1074-LS | Phase I open-label single arm study n = 10 | PI: Caskey, Rockefeller University, USA | Aug 2020 | Safety Pharmacokinetics Decline in HIV VL through week 4 |
NCT03719664 | Albuvirtide (long-acting fusion inhibitor) bNAb: 3BNC117 | Phase II open-label randomised controlled trial n = 80 | PI: Yao Frontier Biotechnologies Inc., USA | Apr 2020 | Proportion with HIV VL < 50 copies/ml |
NCT03707977 | bNAbs: VRC01LS, 10-1074 | Phase I/II open-label non-randomised trial in children n = 40 | PI: Shapiro, Kuritzkes, Licterfield National Institute of Allergy and Infectious Diseases, USA (Study in Botswana) | Jun 2019 | Safety Proportion with HIV VL < 400 copies/ml Proportion with HIV VL < 40 copies/ml |