HVTN 136/ HPTN 092

Status:Ongoing
Phase:I
Principal Investigator(s):Christopher Hurt, Kathryn Stephenson, Srilatha Edupuganti
Objective:Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of the Monoclonal Antibody PGT121.414.LS Administered Alone and in Combination With VRC07-523LS Via Intravenous or Subcutaneous Infusions in Healthy, HIV-uninfected Adult ParticipantsAugust 2022 update (from AIDS 2022): Enrollment completeLast updated August 9, 2022
Prevention Option(s):HIV Vaccine
Study Design:Open label, Randomized
Arms and Assigned Interventions
Descriptionparticipants will receive 3 mg/kg of PGT121.414.LS by intravenous (IV) infusion at Month 0. Biological: PGT121.414.LS Administered via IV infusion or SC infusion, depending on the arm
Mode of DeliveryIV Infusions, Subcutaneous
ARMsExperimental
DescriptionParticipants will receive 10 mg/kg of PGT121.414.LS by IV infusion at Month 0. Biological: PGT121.414.LS Administered via IV infusion or SC infusion, depending on the arm
Mode of Delivery
ARMsExperimental
DescriptionParticipants will receive 30 mg/kg of PGT121.414.LS by IV infusion at Month 0. Biological: PGT121.414.LS Administered via IV infusion or SC infusion, depending on the arm
Mode of DeliveryIV Infusions, Subcutaneous
ARMsExperimental
DescriptionParticipants will receive 5 mg/kg of PGT121.414.LS by subcutaneous (SC) infusion at Month 0. Biological: PGT121.414.LS Administered via IV infusion or SC infusion, depending on the arm
Mode of DeliveryIV Infusions, Subcutaneous
ARMsExperimental
DescriptionParticipants will receive 20 mg/kg of PGT121.414.LS and 20 mg/kg of VRC07-523LS by IV infusion sequentially in this order at Months 0, 4, and 8. Biological: PGT121.414.LS Administered via IV infusion or SC infusion, depending on the arm Biological: VRC07-523LS Administered via IV infusion or SC infusion, depending on the arm
Mode of DeliveryIV Infusions, Subcutaneous
ARMsExperimental
DescriptionParticipants will receive 5 mg/kg of PGT121.414.LS and 5 mg/kg of VRC07-523LS by SC infusion sequentially in this order at Months 0, 4, and 8. Biological: PGT121.414.LS Administered via IV infusion or SC infusion, depending on the arm Biological: VRC07-523LS Administered via IV infusion or SC infusion, depending on the arm
Mode of DeliveryIV Infusions, Subcutaneous
ARMsExperimental
Official Code: NCT04212091
Trial Sponsors: NIAID (DAID-ES: 38634)
Start Date
End Date
November 10, 2020
August 5, 2022
Enrollment:32
Age range: 18 Years ↔ 50 Years
Population:Cisgender Men, Cisgender Women