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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2020-01-30 |
| Est. Completion | 2023-02-27 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04223804
The ClinicalTrials.gov registry entry for NCT04223804 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (83% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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