AzTrials
AzTrials

Human Immuno-deficiency Virus (HIV) DiseasePhase 2NCT06032546

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

A Phase 2 study testing Budigalimab and ABBV-382 in people with Human Immuno-deficiency Virus (HIV) Disease, run by AbbVie at 80 sites in 13 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Budigalimab and ABBV-382
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
163 participants
Where
80 sitesin 13 countries
Study dates
12 Oct 2023to 22 Sep 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

80 sites in 13 countries.

80 sites in 13 countries

United States43 sites

  • The University of New Mexico /ID# 257533

    Albuquerque, New Mexico, 87106

  • Winship At Emory University Hospital Midtown /ID# 258410

    Atlanta, Georgia, 30308

  • Central Texas Clinical Research /ID# 256920

    Austin, Texas, 78705-3326

  • Franco Felizarta, Md /Id# 256927

    Bakersfield, California, 93301

  • AHF Research Center /ID# 257025

    Beverly Hills, California, 90211

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

    Birmingham, Alabama, 35222-2309

  • Cooper University Health Care - Camden /ID# 258133

    Camden, New Jersey, 08103

  • Howard Brown Health Center /ID# 257485

    Chicago, Illinois, 60613-2010

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

    Dallas, Texas, 75208-4599

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

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center /ID# 257551

    Dallas, Texas, 75390-7208

  • Metro Infectious Disease Consultants /ID# 256955

    Decatur, Georgia, 30033

  • Midland Florida Clinical Research Center /ID# 257101

    DeLand, Florida, 32720-0920

  • Ahf Healthcare Center - Northpoint /ID# 256934

    Fort Lauderdale, Florida, 33308

  • Texas Center for Infectious Disease Associates /ID# 257183

    Fort Worth, Texas, 76104

  • Midway Immunology and Research Center /ID# 256930

    Ft. Pierce, Florida, 34982

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

    Greenville, North Carolina, 27834

  • The Crofoot Research Center, Inc /ID# 256921

    Houston, Texas, 77098-3900

  • KC CARE Health Center - Midtown South /ID# 257178

    Kansas City, Missouri, 64111

  • Las Vegas Research Center /ID# 257619

    Las Vegas, Nevada, 89106

  • Long Beach Education and Research Consultants /ID# 257552

    Long Beach, California, 90813-3267

  • DCOL Center for Clinical Research /ID# 257093

    Longview, Texas, 75605

  • AHF Healthcare Center- Hollywood /ID# 257026

    Los Angeles, California, 90027

  • Los Angeles LGBT Center /ID# 258407

    Los Angeles, California, 90028-6213

  • Ruane Clinical Research Group /ID# 256932

    Los Angeles, California, 90036

  • Advanced Pharma CR, LLC /ID# 259335

    Miami, Florida, 33147

  • Wisconsin Medical Center /ID# 257498

    Milwaukee, Wisconsin, 53226

  • Saint Michael's Medical Center /ID# 258802

    Newark, New Jersey, 07102

  • Orlando Immunology Center /ID# 256931

    Orlando, Florida, 32803

  • Bliss Health /ID# 257827

    Orlando, Florida, 32806-3300

  • Palmtree Clinical Research Inc. /Id# 258409

    Palm Springs, California, 92262

  • Optimus Medical /ID# 257182

    San Francisco, California, 94102

  • Quest Clinical Research /ID# 256928

    San Francisco, California, 94115-3037

  • South Jersey Infectious Disease /ID# 257840

    Somers Point, New Jersey, 08244

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

    Springfield, Massachusetts, 01105-1406

  • Suny Upstate University Hospital Community Campus /ID# 257847

    Syracuse, New York, 13215

  • Baycare Medical Group - Tampa /ID# 256953

    Tampa, Florida, 33614

  • Jacobi Medical Center /ID# 257849

    The Bronx, New York, 10461

  • Montefiore Medical Center /ID# 257792

    The Bronx, New York, 10467

  • The Pierone Research Institute /ID# 257022

    Vero Beach, Florida, 32960-6541

  • Washington Health Institute /ID# 259336

    Washington D.C., District of Columbia, 20017

  • Triple O Research Institute /ID# 256929

    West Palm Beach, Florida, 33407

  • Atrium Health Wake Forest Baptist Medical Center /ID# 257542

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada6 sites

  • McGill University Health Centre - Glen Site. /ID# 256992

    Montreal, Quebec, H4A 3J1

  • Ottawa Hospital Research Institute /ID# 256993

    Ottawa, Ontario, K1H 8L6

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

    Québec, Quebec, G1V 4G2

  • Regina General Hospital - Infectious Disease Clinic /ID# 260243

    Regina, Saskatchewan, S4P 0W5

  • Duplicate_Toronto General Hospital /ID# 256994

    Toronto, Ontario, M5G 2C4

  • Spectrum Health Vancouver /ID# 260791

    Vancouver, British Columbia, V6Z 2T1

Other trials in Canada

Belgium4 sites

  • Universite Libre de Bruxelles - Hopital Erasme /ID# 257433

    Anderlecht, Brussels Capital, 1070

  • CHU Saint Pierre /ID# 257447

    Brussels, Brussels Capital, 1000

  • Cliniques Universitaires UCL Saint-Luc /ID# 257444

    Brussels, Brussels Capital, 1200

  • UZ Gent /ID# 257446

    Ghent, Oost-Vlaanderen, 9000

Other trials in Belgium

Italy4 sites

  • IRCCS Ospedale San Raffaele /ID# 259820

    Milan, Milano, 20132

  • ASST Grande Ospedale Metropolitano Niguarda /ID# 257410

    Milan, Milano, 20162

  • Azienda Ospedaliero-Universitaria di Modena /ID# 257411

    Modena, 41124

  • Azienda Ospedaliera Universitaria Federico II - Naples /ID# 257412

    Naples, Napoli, 80131

Other trials in Italy

South Africa4 sites

  • Wits RHI Research Centre /ID# 257354

    Johannesburg, Gauteng, 2001

  • Perinatal HIV Research Unit (PHRU) /ID# 257350

    Johannesburg, Gauteng, 2013

  • Clinical HIV Research Unit (CHRU) /ID# 257358

    Johannesburg, Gauteng, 2092

  • Ezintsha Research Centre /ID# 257391

    Johannesburg, Gauteng, 2193

Other trials in South Africa

Spain4 sites

  • Hospital Universitario Germans Trias i Pujol /ID# 257268

    Badalona, Barcelona, 08916

  • Hospital Clinic de Barcelona /ID# 257269

    Barcelona, 08036

  • Hospital Universitario Ramon y Cajal /ID# 257266

    Madrid, 28034

  • Hospital Universitario La Paz /ID# 257170

    Madrid, 28046

Other trials in Spain

Germany3 sites

  • zibp-Zentrum fuer Infektiologie /ID# 257110

    Berlin, 10439

  • Universitaetsklinikum Bonn /ID# 257113

    Bonn, North Rhine-Westphalia, 53127

  • Infektiologikum /ID# 257112

    Frankfurt am Main, Hesse, 60596

Other trials in Germany

Japan3 sites

  • NHO Nagoya Medical Center /ID# 261433

    Nagoya, Aichi-ken, 460-0001

  • National Hospital Organization Osaka National Hospital /ID# 261520

    Osaka, Osaka, 540-0006

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

    Tokyo, 108-8639

Other trials in Japan

France2 sites

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

    Paris, 75012

  • AP-HP - Hopital Tenon /ID# 258091

    Paris, 75020

Other trials in France

Poland2 sites

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

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-030

  • Punkt Zdrowia /ID# 257950

    Gdansk, Pomeranian Voivodeship, 80-405

Other trials in Poland

Puerto Rico2 sites

  • Clinical Research Puerto Rico /ID# 256956

    San Juan, 00909-1711

  • HOPE Clinical Research /ID# 257487

    San Juan, 00909

Other trials in Puerto Rico

United Kingdom2 sites

  • Royal Free Hospital /ID# 257453

    London, Greater London, NW3 2QG

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

    London, Greater London, SE1 9RT

Other trials in United Kingdom

Brazil1 site

  • Ricardo Diaz Scientific Solution /ID# 257335

    São Paulo, São Paulo, 04037-030

Other trials in Brazil

About this study

Official title: 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.

Read more

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.

Being tested
Budigalimab, Placebo for Budigalimab, ABBV-382, Placebo for ABBV-382
Keywords
Human immuno-deficiency virus (HIV) Disease, Budigalimab, ABBV-382
Medical subject headings
Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BudigalimabDrug

    Also called ABBV-181

    Intravenous (IV) Infusion

  • Placebo for BudigalimabDrug

    IV Infusion

  • ABBV-382Drug

    IV Infusion

  • Placebo for ABBV-382Drug

    IV Infusion

  • BudigalimabDrug

    Also called ABBV-181

    Subcutaneous (SC) Injection

Study groups in NCT06032546
Study groupRoleWhat they receive
Arm A: PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo for Budigalimab; Drug: Placebo for ABBV-382
Arm B: Budigalimab Dose AExperimentalParticipants 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.
Receives: Drug: Budigalimab; Drug: Placebo for ABBV-382
Arm C: ABBV-382 Dose AExperimentalParticipants 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.
Receives: Drug: Placebo for Budigalimab; Drug: ABBV-382
Arm D: Budigalimab Dose A + ABBV-382 Dose BExperimentalParticipants 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.
Receives: Drug: Budigalimab; Drug: ABBV-382
Arm E: Budigalimab Dose A + ABBV-382 Dose AExperimentalParticipants 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.
Receives: Drug: Budigalimab; Drug: ABBV-382
Arm F: Budigalimab Dose BExperimentalParticipants 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).
Receives: Drug: Budigalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 24

  2. 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.

    Measured: Up to approximately Week 112

Secondary outcomes (2)

  1. Median Peak Log10 Viral Load (At Rebound) Prior to Re-Starting ART

    The median peak log10 viral load (at rebound) before re-starting ART.

    Measured: Up to 112 weeks

  2. Median Time to First Rebound to ≥ 1000 Copies/mL During ART Interruption

    The median time to first rebound to ≥ 1000 copies/mL during ART interruption.

    Measured: Up to 112 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study start12 Oct 2023
  3. Primary completion22 Sep 2025
  4. Study completion22 Sep 2025

Why it stopped: Company Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06032546
Sponsor's protocol ID
M19-965
Other IDs
2023-505900-53-00, 2023
Status last verified
Nov 2026
First submitted
5 Sep 2023
Last updated
6 Nov 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Budigalimab and ABBV-382 in people with Human Immuno-deficiency Virus (HIV) Disease, run by AbbVie at 80 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, Canada, Belgium, Italy, South Africa and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Viral Control Without Antiretroviral Therapy (ART) Restart (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06032546.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in