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Monoclonal Antibodies

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

Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 44 weeks

Summary

This trial is testing a new drug called ABBV-181 in people with HIV who are stopping their usual treatment. The goal is to see if the drug is safe and effective, and how it affects the immune system and the virus.

Eligible Conditions
  • HIV
  • HIV/AIDS

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 44 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 44 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under the Curve (AUCtau)
Half-life (t1/2)
Maximum Observed Concentration (Cmax)
+5 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Stage 2: Arm EExperimental Treatment1 Intervention
Participants will receive ABBV-181 dose C.
Group II: Stage 1: Arm CExperimental Treatment1 Intervention
Participants will receive ABBV-181 dose B.
Group III: Stage 1: Arm BExperimental Treatment1 Intervention
Participants will receive ABBV-181 dose A.
Group IV: Stage 2: Arm DPlacebo Group1 Intervention
Participants will receive Placebo.
Group V: Stage 1: Arm APlacebo Group1 Intervention
Participants will receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABBV-181
2013
Completed Phase 1
~500

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,040 Previous Clinical Trials
523,538 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
461 Previous Clinical Trials
164,323 Total Patients Enrolled
~7 spots leftby Dec 2025
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