AAAS 1239

Status:Ongoing
Phase:I
Principal Investigator(s):David Ho
Objective:A Phase 1 Dose-escalation Study of the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of the Bispecific Antibody 10E8.4/iMab in HIV-1-infected and Uninfected Individuals Many HIV-infected individuals mount a broad neutralizing serologic response 2-3 years after infection. Broadly neutralizing antibodies might play an important role in protection from acquisition of HIV infection because they can protect macaques from infection, and the presence of anti-HIV antibodies was the only positive correlate of protection in an HIV vaccine efficacy trial (RV144 trial). HIV neutralizing antibodies also have the potential to alter the course of HIV infection in humans. Therefore, these antibodies might be useful to both prevent and treat HIV-1 infection. This is a phase 1 dose escalating clinical trial to evaluate the safety, tolerability, pharmacokinetics and the antiretroviral effects of a novel bispecific monoclonal antibody 10E8.4/iMab in HIV-infected and HIV-uninfected individuals. The study will be conducted as a multi-center study at the Columbia University Medical Center in New York City and the Orlando Immunology Center in Orlando, Florida. Last updated September 19, 2022
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionExperimental: Arm 1: 10E8.4/iMab IV or SC HIV- Arm 1; Groups A-C; 3 dosing groups: HIV-uninfected individuals
Mode of DeliveryIV Infusions, Subcutaneous
ARMsExperimental
DescriptionExperimental: Arm 2: 10E8.4/iMab IV HIV- Arm 2; Groups D-F; 3 dosing groups: HIV-uninfected individuals
Mode of DeliveryIV Infusions
ARMsExperimental
DescriptionExperimental: Arm 3 and 3a: 10E8.4/iMab IV HIV+ Arm 3; Group H; 1 dosing group: HIV-infected individuals with HIV-1 RNA levels between 1,000 and 100,000 copies/mL and cluster of differentiation 4 (CD4)>350 cells/mm3; Arm 3a; Group I; 1 dosing group: HIV-infected and suppressed individuals
Mode of DeliveryIV Infusions
ARMsExperimental
DescriptionExperimental: Arm 4: 10E8.4/iMab SC HIV- Arm 4; Groups J and K: HIV-uninfected individuals
Mode of DeliverySubcutaneous
ARMsExperimental
Official Code: NCT03875209
Related Publications:
Prevalence of broadly neutralizing antibody responses during chronic HIV-1 infection
Immune-correlates analysis of an HIV-1 vaccine efficacy trial
Trial Sponsors: Bill & Melinda Gates Foundation, EMMES, IAVI
Start Date
End Date
April 8, 2019
November 22, 2022
Enrollment:54
Age range: 18 Years ↔ 60 Years
Population:Cisgender Men, Cisgender Women