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

NCT06032546 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: M19-9652023-505900-53-00
• Study Type: interventional
• Target: 163
• Locations: 13 countries
• Sites: 80

Brief Summary

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.

Conditions

Human Immuno-deficiency Virus (HIV) Disease

Keywords

Human immuno-deficiency virus (HIV) Disease; Budigalimab; ABBV-382

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants with Viral Control Without Antiretroviral Therapy (ART) Restart

  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)

  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 Outcomes (2)

• Median Peak Viral Load (At Rebound) Prior to Re-Starting ART

  Up to 112 weeks

• Median Time to First Rebound to >= 1000 Copies/mL During ART Interruption

  Up to 112 weeks

Study Arms (6)

Arm A: Placebo

PLACEBO COMPARATOR

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; Drug: Placebo for ABBV-382

Arm B: Budigalimab Dose A

EXPERIMENTAL

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; Drug: Placebo for ABBV-382

Arm C: ABBV-382 Dose A

EXPERIMENTAL

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; Drug: ABBV-382

Arm D: Budigalimab Dose A + ABBV-382 Dose B

EXPERIMENTAL

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; Drug: ABBV-382

Arm E: Budigalimab Dose A + ABBV-382 Dose A

EXPERIMENTAL

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; Drug: ABBV-382

Arm F: Budigalimab Dose B

EXPERIMENTAL

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

Interventions

Budigalimab DRUG

Intravenous (IV) Infusion

Also known as: ABBV-181

Arm B: Budigalimab Dose A; Arm D: Budigalimab Dose A + ABBV-382 Dose B; Arm E: Budigalimab Dose A + ABBV-382 Dose A

Placebo for Budigalimab DRUG

IV Infusion

Arm A: Placebo; Arm C: ABBV-382 Dose A

ABBV-382 DRUG

IV Infusion

Arm C: ABBV-382 Dose A; Arm D: Budigalimab Dose A + ABBV-382 Dose B; Arm E: Budigalimab Dose A + ABBV-382 Dose A

Placebo for ABBV-382 DRUG

IV Infusion

Arm A: Placebo; Arm B: Budigalimab Dose A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (80)

University of Alabama at Birmingham, 1917 Research Clinic /ID# 257549

Birmingham, Alabama, 35222-2309, United States

Location

Franco Felizarta, Md /Id# 256927

Bakersfield, California, 93301, United States

Location

AHF Research Center /ID# 257025

Beverly Hills, California, 90211, United States

Location

Long Beach Education and Research Consultants /ID# 257552

Long Beach, California, 90813-3267, United States

Location

AHF Healthcare Center- Hollywood /ID# 257026

Los Angeles, California, 90027, United States

Location

Los Angeles LGBT Center /ID# 258407

Los Angeles, California, 90028-6213, United States

Location

Ruane Clinical Research Group /ID# 256932

Los Angeles, California, 90036, United States

Location

Palmtree Clinical Research Inc. /Id# 258409

Palm Springs, California, 92262, United States

Location

Optimus Medical /ID# 257182

San Francisco, California, 94102, United States

Location

Quest Clinical Research /ID# 256928

San Francisco, California, 94115-3037, United States

Location

Washington Health Institute /ID# 259336

Washington D.C., District of Columbia, 20017, United States

Location

Midland Florida Clinical Research Center /ID# 257101

DeLand, Florida, 32720-0920, United States

Location

AIDS Healthcare Foundation (AHF) - Healthcare Center - Northpoint /ID# 256934

Fort Lauderdale, Florida, 33308, United States

Location

Midway Immunology and Research Center /ID# 256930

Ft. Pierce, Florida, 34982, United States

Location

Advanced Pharma CR, LLC /ID# 259335

Miami, Florida, 33147, United States

Location

Orlando Immunology Center /ID# 256931

Orlando, Florida, 32803, United States

Location

Bliss Health /ID# 257827

Orlando, Florida, 32806-3300, United States

Location

Baycare Medical Group - Tampa /ID# 256953

Tampa, Florida, 33614, United States

Location

The Pierone Research Institute /ID# 257022

Vero Beach, Florida, 32960-6541, United States

Location

Triple O Research Institute /ID# 256929

West Palm Beach, Florida, 33407, United States

Location

Winship At Emory University Hospital Midtown /ID# 258410

Atlanta, Georgia, 30308, United States

Location

Metro Infectious Disease Consultants, P.L.L.C /ID# 256955

Decatur, Georgia, 30033, United States

Location

Howard Brown Health Center /ID# 257485

Chicago, Illinois, 60613-2010, United States

Location

Claudia T. Martorell MD LLC dba The Research Institute /ID# 259155

Springfield, Massachusetts, 01105-1406, United States

Location

KC CARE Health Center - Midtown South /ID# 257178

Kansas City, Missouri, 64111, United States

Location

Las Vegas Research Center /ID# 257619

Las Vegas, Nevada, 89106, United States

Location

Cooper University Health Care - Camden /ID# 258133

Camden, New Jersey, 08103, United States

Location

Saint Michael's Medical Center /ID# 258802

Newark, New Jersey, 07102, United States

Location

South Jersey Infectious Disease /ID# 257840

Somers Point, New Jersey, 08244, United States

Location

Unmhsc /Id# 257533

Albuquerque, New Mexico, 87102-2612, United States

Location

Suny Upstate University Hospital Community Campus /ID# 257847

Syracuse, New York, 13215, United States

Location

Jacobi Medical Center /ID# 257849

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center /ID# 257792

The Bronx, New York, 10467, United States

Location

East Carolina University - Brody School of Medicine /ID# 257544

Greenville, North Carolina, 27834, United States

Location

Atrium Health Wake Forest Baptist Medical Center /ID# 257542

Winston-Salem, North Carolina, 27157, United States

Location

Central Texas Clinical Research /ID# 256920

Austin, Texas, 78705-3326, United States

Location

Prism Health North Texas - Oak Cliff Health Center /ID# 256933

Dallas, Texas, 75208-4599, United States

Location

North Texas Infectious Diseases Consultants, P.A /ID# 257592

Dallas, Texas, 75246, United States

Location

University of Texas Southwestern Medical Center /ID# 257551

Dallas, Texas, 75390-7208, United States

Location

Texas Center for Infectious Disease Associates /ID# 257183

Fort Worth, Texas, 76104, United States

Location

The Crofoot Research Center, Inc /ID# 256921

Houston, Texas, 77098-3900, United States

Location

DCOL Center for Clinical Research /ID# 257093

Longview, Texas, 75605, United States

Location

Wisconsin Medical Center /ID# 257498

Milwaukee, Wisconsin, 53226, United States

Location

Universite Libre de Bruxelles - Hopital Erasme /ID# 257433

Anderlecht, Brussels Capital, 1070, Belgium

Location

CHU Saint Pierre /ID# 257447

Brussels, Brussels Capital, 1000, Belgium

Location

Cliniques Universitaires UCL Saint-Luc /ID# 257444

Brussels, Brussels Capital, 1200, Belgium

Location

UZ Gent /ID# 257446

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Ricardo Diaz Scientific Solution /ID# 257335

São Paulo, São Paulo, 04037-030, Brazil

Location

Spectrum Health Vancouver /ID# 260791

Vancouver, British Columbia, V6Z 2T1, Canada

Location

Ottawa Hospital Research Institute /ID# 256993

Ottawa, Ontario, K1H 8L6, Canada

Location

Toronto General Hospital /ID# 256994

Toronto, Ontario, M5G 2C4, Canada

Location

McGill University Health Centre - Glen Site /ID# 256992

Montreal, Quebec, H4A 3J1, Canada

Location

CHU de Quebec-Université Laval hôpital CHUL /ID# 261611

Québec, Quebec, G1V 4G2, Canada

Location

Regina General Hospital - Infectious Disease Clinic /ID# 260243

Regina, Saskatchewan, S4P 0W5, Canada

Location

AP-HP - Hopital Saint-Antoine /ID# 258090

Paris, 75012, France

Location

AP-HP - Hopital Tenon /ID# 258091

Paris, 75020, France

Location

Infektiologikum /ID# 257112

Frankfurt am Main, Hesse, 60596, Germany

Location

Universitaetsklinikum Bonn /ID# 257113

Bonn, North Rhine-Westphalia, 53127, Germany

Location

zibp-Zentrum fuer Infektiologie /ID# 257110

Berlin, 10439, Germany

Location

IRCCS Ospedale San Raffaele /ID# 259820

Milan, Milano, 20132, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda /ID# 257410

Milan, Milano, 20162, Italy

Location

Azienda Ospedaliera Universitaria Federico II /ID# 257412

Naples, Napoli, 80131, Italy

Location

Azienda Ospedaliero-Universitaria di Modena /ID# 257411

Modena, 41124, Italy

Location

NHO Nagoya Medical Center /ID# 261433

Nagoya, Aichi-ken, 460-0001, Japan

Location

National Hospital Organization Osaka National Hospital /ID# 261520

Osaka, Osaka, 540-0006, Japan

Location

IMSUT Hospital, The Institute of Medical Science, The University of Tokyo /ID# 265344

Tokyo, 108-8639, Japan

Location

Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 259184

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-030, Poland

Location

Punkt Zdrowia /ID# 257950

Gdansk, Pomeranian Voivodeship, 80-405, Poland

Location

Clinical Research Puerto Rico /ID# 256956

San Juan, 00909-1711, Puerto Rico

Location

HOPE Clinical Research /ID# 257487

San Juan, 00909, Puerto Rico

Location

Wits RHI Research Centre /ID# 257354

Johannesburg, Gauteng, 2001, South Africa

Location

Perinatal HIV Research Unit (PHRU) /ID# 257350

Johannesburg, Gauteng, 2013, South Africa

Location

Clinical HIV Research Unit (CHRU) /ID# 257358

Johannesburg, Gauteng, 2092, South Africa

Location

Ezintsha Research Centre /ID# 257391

Johannesburg, Gauteng, 2193, South Africa

Location

Hospital Universitario Germans Trias i Pujol /ID# 257268

Badalona, Barcelona, 08916, Spain

Location

Hospital Clinic de Barcelona /ID# 257269

Barcelona, 08036, Spain

Location

Hospital Universitario Ramon y Cajal /ID# 257266

Madrid, 28034, Spain

Location

Hospital Universitario La Paz /ID# 257170

Madrid, 28046, Spain

Location

Royal Free Hospital /ID# 257453

London, Greater London, NW3 2QG, United Kingdom

Location

Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 257761

London, Greater London, SE1 9RT, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Disease

Interventions

budigalimab

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: October 12, 2023
• Primary Completion: September 22, 2025
• Study Completion: September 22, 2025
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

GB (2); CA (6); JP (3); PR (2); US (43); FR (2); BE (4); ZA (4); PL (2); ES (4); IT (4); BR (1); DE (3)