A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion or Subcutaneous (SC) Injection of Budigalimab and/or ABBV-382
Terminated · Phase 2 · NCT06032546
Conditions: Human Immuno-deficiency Virus (HIV) Disease
At a glance
- Research payments reported, 2025
- $1.3M
- U.S. investigators named
- 38
- Sites paid
- 37
- Planned or actual enrollment
- 163
About the trial
- Sponsor
- AbbVie
- Tested
- Budigalimab (drug), Placebo for Budigalimab (drug), ABBV-382 (drug), Placebo for ABBV-382 (drug), Budigalimab (drug)
- Dates
- Started 2023-10-12; completion 2025-09-22
- Results posted
- Yes
Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency Syndrome (AIDS). HIV disease is considered to be a chronic disease requiring lifelong therapy. The purpose of this study is to assess change in disease activity, adverse events, tolerability, and how the drug moves through the body. Budigalimab and ABBV-382 are investigational drugs being developed for the treatment of HIV disease. In Part 1, participants are placed in 1 of 5 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 7 chance that participants will be assigned to placebo (A placebo is not a drug and it is not expected to have any chemical effects on your …
From ClinicalTrials.gov, last updated 2026-11-06. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $1.3M in research payments for this study in 2025 (268 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Sonya Heath Infectious Disease · Birmingham, AL
- Robert K. Bolan, M.D. Specialist · Los Angeles, CA
- Franco A. Felizarta, MD Infectious Disease · Bakersfield, CA
- Shawn K. Hassler, M.D. Infectious Disease · San Francisco, CA
- Jacob Lalezari, M.D. Internal Medicine · San Francisco, CA
- Carl E. Millner, MD Internal Medicine · Beverly Hills, CA
- Peter Ruane, MD Infectious Disease · Los Angeles, CA
- Stefan Schneider, MD Infectious Disease · Long Beach, CA
- Mona-gekanju Toeque, M.D.,MPH Infectious Disease · Los Angeles, CA
- Theo W. Hodge JR., MD Infectious Disease · Washington, DC
- Simon C. Abelson, MD Internal Medicine · Miami, FL
- Zachary Henry, D.O. Internal Medicine · Fort Lauderdale, FL
- Cynthia A. Mayer, DO Infectious Disease · Tampa, FL
- Godson I. Oguchi, M.D. Infectious Disease · Orange City, FL
- Roberto Ortiz, MD Infectious Disease · Orlando, FL
- Olayemi O. Osiyemi, MD Infectious Disease · West Palm Beach, FL
- Gerald Pierone JR., MD Internal Medicine · Vero Beach, FL
- Moti N. Ramgopal, MD Infectious Disease · Fort Pierce, FL
- Charlotte-paige M. Rolle, M.D. Infectious Disease · Orlando, FL
- Catherine M. Creticos, MD Infectious Disease · Chicago, IL
- Claudia T. Martorell, MD Infectious Disease · Springfield, MA
- Caryn G. Morse, M.D., M.P.H. Infectious Disease · Bethesda, MD
- Craig A. Dietz, D.O. Internal Medicine · Kansas City, MO
- Paul P. Cook, MD Infectious Disease · Greenville, NC
- John D. Baxter, MD Infectious Disease · Camden, NJ
- Christopher Lucasti, DO FACOI Infectious Disease · Somers Point, NJ
- Jihad Slim, MD Infectious Disease · Newark, NJ
- Michelle J. Iandiorio, M.D. Internal Medicine · Albuquerque, NM
- Alireza Farabi, MD Infectious Disease · Las Vegas, NV
- Elizabeth A. Asiago-reddy, MD Infectious Disease · Syracuse, NY
- Javier O. Morales-ramirez, M.D. Infectious Disease · San Juan, PR
- Christopher J. Bettacchi, MD Infectious Disease · Dallas, TX
- Cynthia C. Brinson, M.D. Family Medicine · Austin, TX
- Gordon E. Crofoot JR., MD Internal Medicine · Houston, TX
- Mamta K. Jain, MD MPH Infectious Disease · Dallas, TX
- Anita R. Scribner, MD Internal Medicine · Longview, TX
- Gary I. Sinclair, MD Internal Medicine · Dallas, TX
- Michael O. Frank, MD Infectious Disease · Milwaukee, WI
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Optimus Medical Group $177,892
- Las Vegas Research Center Inc $113,132
- Orlando Immunology Center PA $108,341
- Bliss Health $75,972
- Washington Health Institute $75,569
- Lalezari Medical Corporation $73,462
- Triple O Research Institute PA $58,074
- Medical College of Wisconsin $49,644
- Franco Antonio Balamban Felizarta $45,345
- Long Beach Education & Research $43,226
- Aids Healthcare Foundation DBA Ahf Research $40,239
- Kansas City Care Clinic $38,164
- Claudia Martorell $37,483
- The Research Foundation for The $34,609
- La Gay and Lesbian Community $32,802
- Baycare Health System Inc $32,595
- Associated Clinicians of East Texas $28,720
- The University of Texas $27,584
- East Carolina University $24,375
- University of New Mexico Foundation $23,760
- University of Alabama Hospital, AL $22,075
- The Crofoot Research Center Inc $20,189
- Central Texas Clinical Research $20,088
- Midland Florida Clinical $13,133
- Advanced Pharma Cr LLC $11,995
- South Jersey Infectious Disease $8,883
- The Pierone Research Institute $8,526
- Howard Brown Health Center $7,856
- Cooper University Hospital, NJ $7,361
- Midway Immunology And $6,454
- Saint Michael's Medical Center, NJ $6,442
- Wake Forest University $5,824
- Aids Healthcare Foundation $5,269
- North Texas Infectious Diseases $4,590
- Ruane Clinical Research Group Inc $4,576
- Clinical Research Puerto Rico Inc $3,431
- Aids Arms Inc $2,115
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.