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Monoclonal Antibodies

Budigalimab for HIV/AIDS

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 24 weeks
Awards & highlights

Study Summary

This trial will evaluate the safety and how Budigalimab moves through the body in adults with HIV-1 infection.

Eligible Conditions
  • HIV/AIDS

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma Concentration-time Curve (AUC) of Budigalimab in Plasma
Maximum Serum Concentration (Cmax)
Number of Participants Experiencing Study Drug-Related Grade 3 or Higher Adverse Events (AEs)
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group 4: Placebo SC + Budigalimab IVExperimental Treatment2 Interventions
Participants will receive Subcutaneous (SC) Placebo, followed by IV Budigalimab.
Group II: Group 3: Budigalimab SC + Placebo IVExperimental Treatment2 Interventions
Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo.
Group III: Group 2: Budigalimab (SC) + Placebo IVExperimental Treatment2 Interventions
Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo.
Group IV: Group 1: Placebo SC + Placebo IVExperimental Treatment1 Intervention
Participants will receive Subcutaneous (SC) Placebo, followed by Intravenous (IV) Placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Budigalimab
2021
Completed Phase 1
~170

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,362 Total Patients Enrolled
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
101,524 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
147,076 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Safety and How the Body Handles a Single Dose of Subcutaneous (SC) and Intravenous (IV) Budigalimab in Adult Participants Living With Human Immunodeficiency Virus (HIV)
2021. "Study to Evaluate the Safety and How the Body Handles a Single Dose of Subcutaneous (SC) and Intravenous (IV) Budigalimab in Adult Participants Living With Human Immunodeficiency Virus (HIV)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04799353.
~8 spots leftby Apr 2025
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