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Table 1 Summary of current or future clinical trials involving bNAbs 3BNC117 or 10-1074 (including long-acting -LS versions)

From: The 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

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