HVTN 130/ HPTN 089
Status:
Phase:I
Principal Investigator(s):Magdalena Sobieszczyk, Sharon Mannheimer
Objective:This study will evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS administered via intravenous infusion in healthy, HIV-uninfected adults.Last updated August 9, 2022
Prevention Option(s):HIV Vaccine
Study Design:Open label, Randomized
Arms and Assigned Interventions
DescriptionParticipants will receive PGT121 and VRC07-523LS administered sequentially in this order at Day 0.
Biological: PGT121
20 mg/kg administered intravenously
Biological: VRC07-523LS
20 mg/kg administered intravenously
Mode of DeliveryIV Infusions
ARMsExperimental
DescriptionParticipants will receive PGDM1400 and VRC07-523LS administered sequentially in this order at Day 0.
Biological: PGDM1400
20 mg/kg administered intravenously
Biological: VRC07-523LS
20 mg/kg administered intravenously
Mode of DeliveryIV Infusions
ARMsExperimental
DescriptionParticipants will receive 10-1074 and VRC07-523LS administered sequentially in this order at Day 0.
Biological: 10-1074
20 mg/kg administered intravenously
Biological: VRC07-523LS
20 mg/kg administered intravenously
Mode of DeliveryIV Infusions
ARMsExperimental
DescriptionParticipants will receive PGDM1400, PGT121, and VRC07-523LS administered sequentially in this order at Day 0 and Month 4.
Biological: PGT121
20 mg/kg administered intravenously
Biological: PGDM1400
20 mg/kg administered intravenously
Biological: VRC07-523LS
20 mg/kg administered intravenously
Mode of DeliveryIV Infusions
ARMsExperimental
Official Code:
NCT03928821
Trial Sponsors:
NIAID (DIADS-ES: 38531)
Start Date
End Date
April 26, 2019
March 25, 2021
Enrollment:27
Age range:
18 Years ↔
50 Years
Population:Cisgender Men, Cisgender Women