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

NCT03875209 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-03-07

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

10E8.4/iMab

bispecific monoclonal antibody

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • International AIDS Vaccine Initiative

    collaborator NETWORK

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • David Ho

    lead OTHER

Principal Investigators

  • David D. Ho, MD · ADARC at CUIMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-08
Primary Completion
2022-03-23
Completion
2022-03-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03875209 on ClinicalTrials.gov