10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

November 28, 2023

Primary Completion Date

April 30, 2026

Study Completion Date

May 31, 2027

Conditions
HIV-1-infection
Interventions
DRUG

ART

ART is a combination of three or more drugs from different classes of antiretroviral medication.

DRUG

10E8.4/iMab

10E8.4/iMab is an engineered bispecific antibody with two arms combined into a single molecule that exhibits synergistic enhancement of antiviral activity. 10E8.4/iMab will be administered IV at the 600mg or 1800mg dose or IM at 600mg dose to participants in Step 1 per the Schedule of Events (SOE) based on the arm the participant is assigned.

DRUG

VRC07-523LS

VRC07-523LS is an engineered variant of VRC01, a bNAb that targets the CD4 binding site of the HIV-1 envelope. VRC07-523LS will be administered IV at the 1200mg dose to participants in Step 1 per the SOE.

Trial Locations (1)

Unknown

National Institute for Medical Research-Mbeya Medical Resarch Center, Mbeya

All Listed Sponsors
collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

collaborator

US Military HIV Research Program

NETWORK

collaborator

National Institute of Allergy and infectious Diseases (NIAID)/Vaccine Research Center (VRC)

UNKNOWN

lead

David Ho

OTHER

NCT05890963 - 10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults | Biotech Hunter | Biotech Hunter