10E8.4/iMab Bispecific Antibody in HIV-uninfected and HIV-infected Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: HIV-1-infection

In brief

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.

Key facts

Study ID
NCT03875209
Run by
David Ho
People needed
54
Starts
2019-04-08
Expected to finish
2022-03-23
Last updated by the study team
2023-03-07

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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