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
NCT ID: NCT06032546
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
163 participants
INTERVENTIONAL
2023-10-12
2025-09-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1
NCT04223804
Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected With HIV
NCT00000940
Phase II Study of the Safety and Surrogate Marker Efficacy of Butyldeoxynojirimycin (SC-48334) and AZT in Symptomatic HIV-1 Infected Patients With 200 - 500 CD4+ Cells/mm3. (NOTE: Asymptomatic HIV-1 Infected Patients Also Eligible)
NCT00002079
Virologic and Immunologic Activity of Continued Lamivudine (3TC) vs Delavirdine (DLV) in Combination With Indinavir (IDV) and Zidovudine (ZDV) or Stavudine (d4T) in 3TC-Experienced Subjects
NCT00000882
A Clinical Trial of GSK3640254 + Dolutegravir (DTG) in Human Immunodeficiency Virus-1 Infected Treatment-naive Adults
NCT04900038
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Placebo for Budigalimab
IV Infusion
Placebo for ABBV-382
IV Infusion
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.
Budigalimab
Intravenous (IV) Infusion
Placebo for ABBV-382
IV Infusion
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.
Placebo for Budigalimab
IV Infusion
ABBV-382
IV Infusion
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.
Budigalimab
Intravenous (IV) Infusion
ABBV-382
IV Infusion
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.
Budigalimab
Intravenous (IV) Infusion
ABBV-382
IV Infusion
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).
Budigalimab
Subcutaneous (SC) Injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Budigalimab
Intravenous (IV) Infusion
Placebo for Budigalimab
IV Infusion
ABBV-382
IV Infusion
Placebo for ABBV-382
IV Infusion
Budigalimab
Subcutaneous (SC) Injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham, 1917 Research Clinic /ID# 257549
Birmingham, Alabama, United States
Franco Felizarta, Md /Id# 256927
Bakersfield, California, United States
AHF Research Center /ID# 257025
Beverly Hills, California, United States
Long Beach Education and Research Consultants /ID# 257552
Long Beach, California, United States
AHF Healthcare Center- Hollywood /ID# 257026
Los Angeles, California, United States
Los Angeles LGBT Center /ID# 258407
Los Angeles, California, United States
Ruane Clinical Research Group /ID# 256932
Los Angeles, California, United States
Palmtree Clinical Research Inc. /Id# 258409
Palm Springs, California, United States
Optimus Medical /ID# 257182
San Francisco, California, United States
Quest Clinical Research /ID# 256928
San Francisco, California, United States
Washington Health Institute /ID# 259336
Washington D.C., District of Columbia, United States
Midland Florida Clinical Research Center /ID# 257101
DeLand, Florida, United States
AIDS Healthcare Foundation (AHF) - Healthcare Center - Northpoint /ID# 256934
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center /ID# 256930
Ft. Pierce, Florida, United States
Advanced Pharma CR, LLC /ID# 259335
Miami, Florida, United States
Orlando Immunology Center /ID# 256931
Orlando, Florida, United States
Bliss Health /ID# 257827
Orlando, Florida, United States
Baycare Medical Group - Tampa /ID# 256953
Tampa, Florida, United States
The Pierone Research Institute /ID# 257022
Vero Beach, Florida, United States
Triple O Research Institute /ID# 256929
West Palm Beach, Florida, United States
Winship At Emory University Hospital Midtown /ID# 258410
Atlanta, Georgia, United States
Metro Infectious Disease Consultants, P.L.L.C /ID# 256955
Decatur, Georgia, United States
Howard Brown Health Center /ID# 257485
Chicago, Illinois, United States
Claudia T. Martorell MD LLC dba The Research Institute /ID# 259155
Springfield, Massachusetts, United States
KC CARE Health Center - Midtown South /ID# 257178
Kansas City, Missouri, United States
Las Vegas Research Center /ID# 257619
Las Vegas, Nevada, United States
Cooper University Health Care - Camden /ID# 258133
Camden, New Jersey, United States
Saint Michael's Medical Center /ID# 258802
Newark, New Jersey, United States
South Jersey Infectious Disease /ID# 257840
Somers Point, New Jersey, United States
Unmhsc /Id# 257533
Albuquerque, New Mexico, United States
Suny Upstate University Hospital Community Campus /ID# 257847
Syracuse, New York, United States
Jacobi Medical Center /ID# 257849
The Bronx, New York, United States
Montefiore Medical Center /ID# 257792
The Bronx, New York, United States
East Carolina University - Brody School of Medicine /ID# 257544
Greenville, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 257542
Winston-Salem, North Carolina, United States
Central Texas Clinical Research /ID# 256920
Austin, Texas, United States
Prism Health North Texas - Oak Cliff Health Center /ID# 256933
Dallas, Texas, United States
North Texas Infectious Diseases Consultants, P.A /ID# 257592
Dallas, Texas, United States
University of Texas Southwestern Medical Center /ID# 257551
Dallas, Texas, United States
Texas Center for Infectious Disease Associates /ID# 257183
Fort Worth, Texas, United States
The Crofoot Research Center, Inc /ID# 256921
Houston, Texas, United States
DCOL Center for Clinical Research /ID# 257093
Longview, Texas, United States
Wisconsin Medical Center /ID# 257498
Milwaukee, Wisconsin, United States
Universite Libre de Bruxelles - Hopital Erasme /ID# 257433
Anderlecht, Brussels Capital, Belgium
CHU Saint Pierre /ID# 257447
Brussels, Brussels Capital, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 257444
Brussels, Brussels Capital, Belgium
UZ Gent /ID# 257446
Ghent, Oost-Vlaanderen, Belgium
Ricardo Diaz Scientific Solution /ID# 257335
São Paulo, São Paulo, Brazil
Spectrum Health Vancouver /ID# 260791
Vancouver, British Columbia, Canada
Ottawa Hospital Research Institute /ID# 256993
Ottawa, Ontario, Canada
Toronto General Hospital /ID# 256994
Toronto, Ontario, Canada
McGill University Health Centre - Glen Site /ID# 256992
Montreal, Quebec, Canada
CHU de Quebec-Université Laval hôpital CHUL /ID# 261611
Québec, Quebec, Canada
Regina General Hospital - Infectious Disease Clinic /ID# 260243
Regina, Saskatchewan, Canada
AP-HP - Hopital Saint-Antoine /ID# 258090
Paris, , France
AP-HP - Hopital Tenon /ID# 258091
Paris, , France
Infektiologikum /ID# 257112
Frankfurt am Main, Hesse, Germany
Universitaetsklinikum Bonn /ID# 257113
Bonn, North Rhine-Westphalia, Germany
zibp-Zentrum fuer Infektiologie /ID# 257110
Berlin, , Germany
IRCCS Ospedale San Raffaele /ID# 259820
Milan, Milano, Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 257410
Milan, Milano, Italy
Azienda Ospedaliera Universitaria Federico II /ID# 257412
Naples, Napoli, Italy
Azienda Ospedaliero-Universitaria di Modena /ID# 257411
Modena, , Italy
NHO Nagoya Medical Center /ID# 261433
Nagoya, Aichi-ken, Japan
National Hospital Organization Osaka National Hospital /ID# 261520
Osaka, Osaka, Japan
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo /ID# 265344
Tokyo, , Japan
Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 259184
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Punkt Zdrowia /ID# 257950
Gdansk, Pomeranian Voivodeship, Poland
Clinical Research Puerto Rico /ID# 256956
San Juan, , Puerto Rico
HOPE Clinical Research /ID# 257487
San Juan, , Puerto Rico
Wits RHI Research Centre /ID# 257354
Johannesburg, Gauteng, South Africa
Perinatal HIV Research Unit (PHRU) /ID# 257350
Johannesburg, Gauteng, South Africa
Clinical HIV Research Unit (CHRU) /ID# 257358
Johannesburg, Gauteng, South Africa
Ezintsha Research Centre /ID# 257391
Johannesburg, Gauteng, South Africa
Hospital Universitario Germans Trias i Pujol /ID# 257268
Badalona, Barcelona, Spain
Hospital Clinic de Barcelona /ID# 257269
Barcelona, , Spain
Hospital Universitario Ramon y Cajal /ID# 257266
Madrid, , Spain
Hospital Universitario La Paz /ID# 257170
Madrid, , Spain
Royal Free Hospital /ID# 257453
London, Greater London, United Kingdom
Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 257761
London, Greater London, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-505900-53-00
Identifier Type: OTHER
Identifier Source: secondary_id
M19-965
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.