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NCT03875209 · ClinicalTrials.gov registry record · Phase 1
10E8.4/iMab Bispecific Antibody in HIV-uninfected and HIV-infected Adults
A Phase 1 study of HIV-1-infection, sponsored by David Ho.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 2
- Study locations
NCT03875209: Completed Phase 1 study of HIV-1-infection, sponsored by David Ho.
NCT03875209 is a Phase 1 study of HIV-1-infection that has completed, run by David Ho. The registered enrollment target is 54 participants, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (85% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03875209, a Phase 1 study of HIV-1-infection, has completed, sponsored by David Ho.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
Percentage of subjects experiencing a dose limiting toxicity defined as a Grade 3 or 4 adverse events as per the toxicity grading scale for healthy volunteers enrolled in preventative vaccine trials
Conditions Studied
Interventions
- BIOLOGICAL 10E8.4/iMab
Study Locations (2)
Florida
- Orlando Immunology Center - Orlando
New York
- Columbia University Research Unit - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2019-04-08 |
| Est. Completion | 2022-03-23 |
| Phase | Phase 1 |
What the finished NCT03875209 record still lists
NCT03875209 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (85% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 1 intervention - of which 10E8.4/iMab is the first listed.
NCT03875209 reports a single indexed study location in Florida, New York.
Frequently Asked Questions
What is clinical trial NCT03875209 about?
NCT03875209 is a clinical study titled "10E8.4/iMab Bispecific Antibody in HIV-uninfected and HIV-infected Adults". 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 antibodie...
What is the current status of trial NCT03875209?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2019-04-08. Estimated completion is 2022-03-23.
What conditions does trial NCT03875209 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT03875209?
The interventions under investigation include: 10E8.4/iMab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03875209?
This trial is sponsored by David Ho, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03875209 being conducted?
This trial has 2 study locations across Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV-1-infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03875209's enrollment target sits among peer trials
54 47th of 71 higher than 25 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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