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NCT04223804 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1

A Phase 1 study of HIV Infection and Human Immunodeficiency Virus (HIV), sponsored by AbbVie.

Completed
Registry status
Phase 1
Development phase
41
Enrollment target
20
Study locations

NCT04223804: Completed Phase 1 study of HIV Infection and Human Immunodeficiency Virus (HIV), sponsored by AbbVie.

NCT04223804 is a Phase 1 study of HIV Infection and Human Immunodeficiency Virus (HIV) that has completed, run by AbbVie. The registered enrollment target is 41 participants, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04223804, a Phase 1 study of HIV Infection and Human Immunodeficiency Virus (HIV), has completed, sponsored by AbbVie.

COMPLETED
Registry status
Phase 1
Development phase
41 participants
Enrollment target
20
Study locations

Study Summary

This study will be conducted in two stages and will test the safety/tolerability, pharmacokinetics (how the body handles study drug) and pharmacodynamics (effects on the immune system and the virus) of the study drug ABBV-181 in Human immunodeficiency virus (HIV)-1 infected participants undergoing Antiretroviral therapy (ART) interruption.

Primary Outcome

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of the study drug as either having a reasonable possibility or no reasonable possibility. AEs are given a grade from 1-5 with Grade 3 being severe but not life-threatening and requiring hospitalizatio

Conditions Studied

HIV Infection Human Immunodeficiency Virus (HIV) HIV-1

Interventions

  • DRUG Placebo
  • DRUG ABBV-181

Study Locations (20)

Florida

  • Midway Immunology and Research /ID# 215587 - Ft. Pierce
  • University of Miami, Miller School of Medicine /ID# 213833 - Miami
  • Orlando Immunology Center /ID# 243276 - Orlando
  • Triple O Research Institute /ID# 224863 - West Palm Beach

California

  • Franco Felizarta, Md /Id# 215721 - Bakersfield
  • Ruane Clinical Research Group /ID# 224866 - Los Angeles
  • Quest Clinical Research /ID# 215796 - San Francisco

Texas

  • Prism Health North Texas - Oak Cliff Health Center /ID# 214036 - Dallas
  • North TX Infectious Diseases /ID# 224861 - Dallas

New South Wales

  • Holdsworth House Medical Practice /ID# 215352 - Darlinghurst
  • St Vincent's Hospital Sydney /ID# 215354 - Darlinghurst

Ontario

  • Ottawa Hospital Research Institute /ID# 218083 - Ottawa
  • Toronto General Hospital /ID# 218082 - Toronto

District of Columbia

  • George Washington University Medical Faculty Associates /ID# 213893 - Washington D.C.

Michigan

  • Be Well Medical Center /ID# 223841 - Berkley

Minnesota

  • Mayo Clinic - Rochester /ID# 217820 - Rochester

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2020-01-30
Est. Completion 2023-02-27
Phase Phase 1
AbbVie

526 total trials

What the finished NCT04223804 record still lists

NCT04223804 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (83% lower).

The record links to 3 conditions, with HIV Infection appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04223804 names 20 study sites across 12 states, led by Florida, California, Texas.

Frequently Asked Questions

What is clinical trial NCT04223804 about?

NCT04223804 is a clinical study titled "A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1". This study will be conducted in two stages and will test the safety/tolerability, pharmacokinetics (how the body handles study drug) and pharmacodynamics (effects on the immune system and the virus) of the study drug ABBV-181 in Human immunodeficiency virus (HIV)-1 infected participants undergoing A...

What is the current status of trial NCT04223804?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2020-01-30. Estimated completion is 2023-02-27.

What conditions does trial NCT04223804 study?

This clinical trial studies the following conditions: HIV Infection, Human Immunodeficiency Virus (HIV), HIV-1.

What interventions are being tested in trial NCT04223804?

The interventions under investigation include: Placebo (DRUG), ABBV-181 (DRUG).

Who is sponsoring clinical trial NCT04223804?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04223804 being conducted?

This trial has 20 study locations across California, District of Columbia, Florida, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for HIV 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 NCT04223804's enrollment target sits among peer trials

41 44th of 73 higher than 30 of 73 other HIV Infection trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04223804, the US trial registry maintained by the National Library of Medicine. NCT04223804 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.