NCT04223804

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

A Randomized, Double-blind, Placebo-controlled, Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of ABBV-181 in HIV-1 Infected Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Human Immunodeficiency Virus (HIV)
• HIV Infection
• HIV-1

Interventions

Type	Name	Description
DRUG	ABBV-181	Intravenous (IV) Infusion
DRUG	Placebo	Intravenous (IV) infusion

Timeline

• Start date: 2020-01-30
• Primary completion: 2023-02-27
• Completion: 2023-02-27
• First posted: 2020-01-10
• Last updated: 2023-03-09

Locations

23 sites across 4 countries: United States, Australia, Canada, Puerto Rico

Regulatory

• FDA-regulated drug study