10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults
Status:
Not yet recruiting
Trial end date:
2025-02-01
Target enrollment:
Participant gender:
Summary
This is an open-label phase 1b clinical trial enrolling people living with HIV (PLWH) who are
antiretroviral therapy (ART)-naïve or have not been on ART for > 24 weeks. This study will
enroll PLWH to assess the safety, tolerability, and antiviral effect of bispecific and
long-acting bNAbs, alone and in combination. The study will be conducted as a single center
study at National Institute for Medical Research-Mbeya Medical Research Center (NIMR-MMRC) in
Mbeya, Tanzania.
20 PLWH will be sequentially enrolled into one of 5 arms, each arm comprised of 4
participants. Sequential enrollment will occur in the following order:
- Arm 1 will receive standard daily oral ART.
- Arm 2 will receive a single dose of 10E8.4/iMab 600mg intravenous injection (IV).
- Arm 3 will receive a single dose of 10E8.4/iMab 600mg intramuscular injection (IM).
- Arm 4 will receive a single dose of 10E8.4/iMab 1800mg IV.
- Arm 5 will receive a single dose of combination therapy with both 10E8.4/iMab 1800mg IV
and VRC07-523LS 1200mg IV.
Phase:
Phase 1
Details
Lead Sponsor:
David Ho
Collaborators:
Henry M. Jackson Foundation for the Advancement of Military Medicine National Institute of Allergy and infectious Diseases (NIAID)/Vaccine Research Center (VRC) US Military HIV Research Program