HVTN 140/ HPTN 101

Status:Ongoing
Phase:Open Label
Principal Investigator(s):Colleen Kelley, Marc Siegel, Sharana Mahomed
Objective:A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult ParticipantsAugust 2022 (AIDS 2022) update: Currently enrollingLast updated August 10, 2022
Prevention Option(s):HIV Vaccine
Study Design:Open label, Randomized
Arms and Assigned Interventions
DescriptionParticipants will receive PGDM1400LS 5 mg/kg by intravenous (IV) infusion at Month 0 Drug: PGDM1400LS (5mg/kg, IV) 5 mg/kg to be administered via IV infusion
Mode of DeliveryIV Infusions
ARMsExperimental
DescriptionParticipants will receive PGDM1400LS 20 mg/kg by IV infusion at Month 0 Drug: PGDM1400LS (20mg/kg, IV) 20 mg/kg to be administered via IV infusion
Mode of DeliveryIV Infusions
ARMsExperimental
DescriptionParticipants will receive PGDM1400LS 20 mg/kg by subcutaneous (SC) infusion at Month 0 Drug: PGDM1400LS (20mg/kg, SC) 20 mg/kg to be administered via SC infusion
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionParticipants will receive PGDM1400LS 40 mg/kg by IV infusion at Month 0 Drug: PGDM1400LS (40mg/kg, IV) 40 mg/kg to be administered via IV infusion
Mode of DeliveryIV Infusions
ARMs
DescriptionParticipants will receive PGDM1400LS 40 mg/kg by SC infusion at Month 0 Drug: PGDM1400LS (40mg/kg, SC) 40 mg/kg to be administered via SC infusion
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionParticipants will receive PGDM1400LS 20mg/kg + VRC07-523LS 20mg/kg + PGT121.414.LS 20 mg/kg by IV infusion sequentially in this order at Month 0 and Month 4 Drug: PGDM1400LS (20mg/kg, IV) 20 mg/kg to be administered via IV infusion Drug: VRC07-523LS (20mg/kg, IV) VRC07-523LS 20mg/kg administered via IV infusion Drug: PGT121.414.LS (20mg/kg, IV) PGT121.414.LS 20mg/kg administered via IV infusion
Mode of DeliveryIV Infusions
ARMs
Descriptionarticipants will receive PGDM1400LS 20mg/kg + VRC07-523LS 20mg/kg + PGT121.414.LS 20 mg/kg by SC infusion sequentially in this order at Month 0 and Month 4 Drug: PGDM1400LS (20mg/kg, SC) 20 mg/kg to be administered via SC infusion Drug: VRC07-523LS (20mg/kg, SC) VRC07-523LS 20mg/kg administered via SC infusion Drug: PGT121.414.LS (20mg/kg, SC) PGT121.414.LS 20mg/kg administered via SC infusionarticipants will receive PGDM1400LS 20mg/kg + VRC07-523LS 20mg/kg + PGT121.414.LS 20 mg/kg by SC infusion sequentially in this order at Month 0 and Month 4 Drug: PGDM1400LS (20mg/kg, SC) 20 mg/kg to be administered via SC infusion Drug: VRC07-523LS (20mg/kg, SC) VRC07-523LS 20mg/kg administered via SC infusion Drug: PGT121.414.LS (20mg/kg, SC) PGT121.414.LS 20mg/kg administered via SC infusion
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionParticipants will receive PGDM1400LS 1.4gram + VRC07-523LS 1.4gram + PGT121.414.LS 1.4gram by IV infusion sequentially in this order at Month 0 and Month 4 Drug: PGDM1400LS (1.4g, IV) 1.4gram to be administered via IV infusion Drug: VRC07-523LS (1.4g, IV) VRC07-523LS 1.4g administered via IV infusion Drug: PGT121.414.LS (1.4g, IV) PGT121.414.LS 1.4g administered via IV infusion
Mode of DeliveryIV Infusions
ARMsExperimental
DescriptionParticipants will receive PGDM1400LS 1.4gram + VRC07-523LS 1.4gram + PGT121.414.LS 1.4gram by SC infusion sequentially in this order at Month 0 and Month 4 Drug: PGDM1400LS (1.4g, SC) 1.4gram to be administered via SC infusion Drug: VRC07-523LS (1.4g, SC) VRC07-523LS 1.4g administered via SC infusion Drug: PGT121.414.LS (1.4g, SC) PGT121.414.L
Mode of DeliverySubcutaneous
ARMs
DescriptionParticipants will receive PGDM1400LS 40mg/kg + VRC07-523LS 40mg/kg + PGT121.414.LS 40 mg/kg by IV infusion sequentially in this order at Month 0 and Month 4 Drug: PGDM1400LS (40mg/kg, IV) 40 mg/kg to be administered via IV infusion Drug: VRC07-523LS (40mg/kg, IV) VRC07-523LS 40mg/kg administered via IV infusion Drug: PGT121.414.LS (40mg/kg, IV) PGT121.414.LS 40mg/kg administered via IV infusion
Mode of DeliveryIV Infusions
ARMsExperimental
Official Code: NCT05184452
Trial Sponsors: NIAID (DAIDS-ES: 38723)
Start Date
End Date
November 15, 2021
November 30, 2022
Enrollment:95
Age range: 18 Years ↔ 50 Years
Population:Cisgender Men