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

October 28, 2025 updated by: AbbVie

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Budigalimab and/or ABBV-382 in People Living With HIV on Stable Antiretroviral Therapy Undergoing Analytical Treatment Interruption

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 body and it is not designed to treat any disease or illness). In Part 2, eligible participants will be placed in an open-label arm to receive Budigalimab. Approximately 160 adult participants living with HIV disease on stable antiretroviral therapy (ART) willing to undergo Analytical Treatment Interruption (ATI) will be enrolled at approximately 90 sites worldwide.

In Part 1, participants will receive 4 doses of intravenous (IV) budigalimab or placebo combined with 3 doses of IV ABBV-382 or placebo for an 8 week dosing period. In Part 2, participants will receive 4 doses of open-label subcutaneous (SC) Budigalimab for a 6 week dosing period. Participants need to be stable on antiretroviral therapy to participate in the study. If participant qualifies to the study, on the day they receive the first injection, participants will be asked to stop antiretroviral medications (also referred to as analytical treatment interruption or ATI) for 112 weeks or until meeting specific criteria to restart antiretroviral medications. Participants will undergo a closely monitored ART interruption. Protocol-defined ART restart criteria includes participant's request. Participants will be followed for up to approximately 112 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. There will be an option for virtual or home health visits for some of the follow-up visits. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Brussels Capital
      • Anderlecht, Brussels Capital, Belgium, 1070
        • Universite Libre de Bruxelles - Hopital Erasme /ID# 257433
      • Brussels, Brussels Capital, Belgium, 1000
        • CHU Saint Pierre /ID# 257447
      • Brussels, Brussels Capital, Belgium, 1200
        • Cliniques Universitaires UCL Saint-Luc /ID# 257444
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent /ID# 257446
  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 04037-030
        • Ricardo Diaz Scientific Solution /ID# 257335
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2T1
        • Spectrum Health Vancouver /ID# 260791
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital Research Institute /ID# 256993
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital /ID# 256994
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre - Glen Site /ID# 256992
      • Québec, Quebec, Canada, G1V 4G2
        • CHU de Quebec-Université Laval hôpital CHUL /ID# 261611
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P 0W5
        • Regina General Hospital - Infectious Disease Clinic /ID# 260243
  • France
      • Paris, France, 75012
        • AP-HP - Hopital Saint-Antoine /ID# 258090
      • Paris, France, 75020
        • AP-HP - Hopital Tenon /ID# 258091
  • Germany
      • Berlin, Germany, 10439
        • zibp-Zentrum fuer Infektiologie /ID# 257110
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60596
        • Infektiologikum /ID# 257112
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Universitaetsklinikum Bonn /ID# 257113
  • Italy
      • Modena, Italy, 41124
        • Azienda Ospedaliero-Universitaria di Modena /ID# 257411
    • Milano
      • Milan, Milano, Italy, 20132
        • IRCCS Ospedale San Raffaele /ID# 259820
      • Milan, Milano, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda /ID# 257410
    • Napoli
      • Naples, Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II /ID# 257412
  • Japan
      • Tokyo, Japan, 108-8639
        • IMSUT Hospital, The Institute of Medical Science, The University of Tokyo /ID# 265344
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 460-0001
        • NHO Nagoya Medical Center /ID# 261433
    • Osaka
      • Osaka, Osaka, Japan, 540-0006
        • National Hospital Organization Osaka National Hospital /ID# 261520
  • Poland
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-030
        • Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 259184
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-405
        • Punkt Zdrowia /ID# 257950
  • Puerto Rico
      • San Juan, Puerto Rico, 00909-1711
        • Clinical Research Puerto Rico /ID# 256956
      • San Juan, Puerto Rico, 00909
        • HOPE Clinical Research /ID# 257487
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2001
        • Wits RHI Research Centre /ID# 257354
      • Johannesburg, Gauteng, South Africa, 2013
        • Perinatal HIV Research Unit (PHRU) /ID# 257350
      • Johannesburg, Gauteng, South Africa, 2092
        • Clinical HIV Research Unit (CHRU) /ID# 257358
      • Johannesburg, Gauteng, South Africa, 2193
        • Ezintsha Research Centre /ID# 257391
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona /ID# 257269
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal /ID# 257266
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz /ID# 257170
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol /ID# 257268
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, NW3 2QG
        • Royal Free Hospital /ID# 257453
      • London, Greater London, United Kingdom, SE1 9RT
        • Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 257761
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35222-2309
        • University of Alabama at Birmingham, 1917 Research Clinic /ID# 257549
    • California
      • Bakersfield, California, United States, 93301
        • Franco Felizarta, Md /Id# 256927
      • Beverly Hills, California, United States, 90211
        • AHF Research Center /ID# 257025
      • Long Beach, California, United States, 90813-3267
        • Long Beach Education and Research Consultants /ID# 257552
      • Los Angeles, California, United States, 90027
        • AHF Healthcare Center- Hollywood /ID# 257026
      • Los Angeles, California, United States, 90028-6213
        • Los Angeles LGBT Center /ID# 258407
      • Los Angeles, California, United States, 90036
        • Ruane Clinical Research Group /ID# 256932
      • Palm Springs, California, United States, 92262
        • Palmtree Clinical Research Inc. /Id# 258409
      • San Francisco, California, United States, 94102
        • Optimus Medical /ID# 257182
      • San Francisco, California, United States, 94115-3037
        • Quest Clinical Research /ID# 256928
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20017
        • Washington Health Institute /ID# 259336
    • Florida
      • DeLand, Florida, United States, 32720-0920
        • Midland Florida Clinical Research Center /ID# 257101
      • Fort Lauderdale, Florida, United States, 33308
        • AIDS Healthcare Foundation (AHF) - Healthcare Center - Northpoint /ID# 256934
      • Ft. Pierce, Florida, United States, 34982
        • Midway Immunology and Research Center /ID# 256930
      • Miami, Florida, United States, 33147
        • Advanced Pharma CR, LLC /ID# 259335
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center /ID# 256931
      • Orlando, Florida, United States, 32806-3300
        • Bliss Health /ID# 257827
      • Tampa, Florida, United States, 33614
        • Baycare Medical Group - Tampa /ID# 256953
      • Vero Beach, Florida, United States, 32960-6541
        • The Pierone Research Institute /ID# 257022
      • West Palm Beach, Florida, United States, 33407
        • Triple O Research Institute /ID# 256929
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Winship At Emory University Hospital Midtown /ID# 258410
      • Decatur, Georgia, United States, 30033
        • Metro Infectious Disease Consultants, P.L.L.C /ID# 256955
    • Illinois
      • Chicago, Illinois, United States, 60613-2010
        • Howard Brown Health Center /ID# 257485
    • Massachusetts
      • Springfield, Massachusetts, United States, 01105-1406
        • Claudia T. Martorell MD LLC dba The Research Institute /ID# 259155
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • KC CARE Health Center - Midtown South /ID# 257178
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Las Vegas Research Center /ID# 257619
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Health Care - Camden /ID# 258133
      • Newark, New Jersey, United States, 07102
        • Saint Michael's Medical Center /ID# 258802
      • Somers Point, New Jersey, United States, 08244
        • South Jersey Infectious Disease /ID# 257840
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102-2612
        • Unmhsc /Id# 257533
    • New York
      • Syracuse, New York, United States, 13215
        • Suny Upstate University Hospital Community Campus /ID# 257847
      • The Bronx, New York, United States, 10461
        • Jacobi Medical Center /ID# 257849
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center /ID# 257792
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • East Carolina University - Brody School of Medicine /ID# 257544
      • Winston-Salem, North Carolina, United States, 27157
        • Atrium Health Wake Forest Baptist Medical Center /ID# 257542
    • Texas
      • Austin, Texas, United States, 78705-3326
        • Central Texas Clinical Research /ID# 256920
      • Dallas, Texas, United States, 75208-4599
        • Prism Health North Texas - Oak Cliff Health Center /ID# 256933
      • Dallas, Texas, United States, 75246
        • North Texas Infectious Diseases Consultants, P.A /ID# 257592
      • Dallas, Texas, United States, 75390-7208
        • University of Texas Southwestern Medical Center /ID# 257551
      • Fort Worth, Texas, United States, 76104
        • Texas Center for Infectious Disease Associates /ID# 257183
      • Houston, Texas, United States, 77098-3900
        • The Crofoot Research Center, Inc /ID# 256921
      • Longview, Texas, United States, 75605
        • DCOL Center for Clinical Research /ID# 257093
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Wisconsin Medical Center /ID# 257498

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • A condition of general good health in the opinion of the investigator, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
  • Must be on antiretroviral therapy (ART) for at least 12 months prior to screening and on a stable ART regimen for at least 8 weeks prior to screening (current ART regimen cannot include an Non-nucleoside reverse transcriptase inhibitor [NNRTI] or long-acting ART).
  • Negative human immuno-deficiency virus (HIV)-2 antibody (Ab)
  • Cluster of differentiation 4 (CD4+) T cell count >= 500 cells/μL at screening and no known evidence of CD4+ T cell count < 500 cells/μL in the last 12 months prior to screening
  • Participant must have plasma HIV-1 ribonucleic acid (RNA) below the lower limit of quantitation (LLOQ) at screening and for at least 12 months prior to screening

Exclusion Criteria:

  • Prior exposure to long acting antiretrovirals within 24 weeks or within a period defined by 5 half-lives, whichever is longer, prior to randomization and prior to the first dose of study drug.
  • History of CD4+ T cell nadir of <= 200 cells/μL during chronic HIV infection.
  • History of medical disorders (other than HIV-1 infection) that, in the opinion of the investigator, might expose the participant to undue risk of harm, confound study outcomes or prevent the participant from completing the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Arm A: Placebo
Participants will receive budigalimab placebo on Day 1, and Weeks 2, 4, and 6 in combination with ABBV-382 matching placebo on Day 1 and Weeks 4 and 8.
Drug: Placebo for Budigalimab
IV Infusion
Drug: Placebo for ABBV-382
IV Infusion
Experimental: Arm C: ABBV-382 Dose A
Participants will receive budigalimab placebo on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose A on Day 1 and Weeks 4 and 8.
Drug: Placebo for Budigalimab
IV Infusion
Drug: ABBV-382
IV Infusion
Experimental: Arm B: Budigalimab Dose A
Participants will receive budigalimab Dose A on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 matching placebo Day 1 and Weeks 4 and 8.
Drug: Budigalimab
Intravenous (IV) Infusion
Other Names:
  • ABBV-181
Drug: Placebo for ABBV-382
IV Infusion
Drug: Budigalimab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-181
Experimental: Arm D: Budigalimab Dose A + ABBV-382 Dose B
Participants will receive budigalimab Dose A on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose B on Day 1 and Weeks 4 and 8.
Drug: Budigalimab
Intravenous (IV) Infusion
Other Names:
  • ABBV-181
Drug: Budigalimab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-181
Drug: ABBV-382
IV Infusion
Experimental: Arm E: Budigalimab Dose A + ABBV-382 Dose A
Participants will receive budigalimab Dose A on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose A on Day 1 and Weeks 4 and 8.
Drug: Budigalimab
Intravenous (IV) Infusion
Other Names:
  • ABBV-181
Drug: Budigalimab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-181
Drug: ABBV-382
IV Infusion
Experimental: Arm F: Budigalimab Dose B
Participants will receive open-label budigalimab Dose B on Day 1 and Weeks 2, 4, and 6 (Note, no ABBV-382 or placebo will be administered).
Drug: Budigalimab
Intravenous (IV) Infusion
Other Names:
  • ABBV-181
Drug: Budigalimab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-181

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Viral Control Without Antiretroviral Therapy (ART) Restart
Time Frame: Week 24
Percentage of participants who achieve viral control (viral load < 1000 copies/mL) without ART restart at Week 24.
Week 24
Number of Participants with Adverse Events (AEs)
Time Frame: Up to approximately Week 112
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Up to approximately Week 112

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Peak Viral Load (At Rebound) Prior to Re-Starting ART
Time Frame: Up to 112 weeks
The median peak viral load (at rebound) before re-starting ART.
Up to 112 weeks
Median Time to First Rebound to >= 1000 Copies/mL During ART Interruption
Time Frame: Up to 112 weeks
The median time to rebound to >= 1000 copies/mL during ART interruption.
Up to 112 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2023

Primary Completion (Actual)

September 22, 2025

Study Completion (Actual)

September 22, 2025

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Estimated)

October 29, 2025

Last Update Submitted That Met QC Criteria

October 28, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M19-965
  • 2023-505900-53-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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