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Can a drug combo let HIV patients ditch daily meds?

NCT ID NCT06032546

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two experimental drugs, budigalimab and ABBV-382, in people with HIV who were stable on standard therapy. Participants stopped their usual HIV medications to see if the new drugs could keep the virus under control. The trial was terminated early, so it's unclear if this approach works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Budigalimab and ABBV-382
What this could lead to
If successful, this could point toward a way for people with HIV to control the virus without daily medication, potentially reducing lifelong treatment burden.
What could go wrong
This early-stage trial was terminated, so results are limited. The approach is experimental, and participants must stop their usual HIV drugs, which carries a risk of virus rebound.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

163 people

The number who actually took part.

Started

Oct 2023

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AHF Healthcare Center- Hollywood /ID# 257026

    Los Angeles, California, 90027, United States

  • AHF Research Center /ID# 257025

    Beverly Hills, California, 90211, United States

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

    Fort Lauderdale, Florida, 33308, United States

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

    Paris, 75012, France

  • AP-HP - Hopital Tenon /ID# 258091

    Paris, 75020, France

  • ASST Grande Ospedale Metropolitano Niguarda /ID# 257410

    Milan, Milano, 20162, Italy

  • Advanced Pharma CR, LLC /ID# 259335

    Miami, Florida, 33147, United States

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

    Winston-Salem, North Carolina, 27157, United States

  • Azienda Ospedaliera Universitaria Federico II /ID# 257412

    Naples, Napoli, 80131, Italy

  • Azienda Ospedaliero-Universitaria di Modena /ID# 257411

    Modena, 41124, Italy

  • Baycare Medical Group - Tampa /ID# 256953

    Tampa, Florida, 33614, United States

  • Bliss Health /ID# 257827

    Orlando, Florida, 32806-3300, United States

  • CHU Saint Pierre /ID# 257447

    Brussels, Brussels Capital, 1000, Belgium

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

    Québec, Quebec, G1V 4G2, Canada

  • Central Texas Clinical Research /ID# 256920

    Austin, Texas, 78705-3326, United States

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

    Springfield, Massachusetts, 01105-1406, United States

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

    Johannesburg, Gauteng, 2092, South Africa

  • Clinical Research Puerto Rico /ID# 256956

    San Juan, 00909-1711, Puerto Rico

  • Cliniques Universitaires UCL Saint-Luc /ID# 257444

    Brussels, Brussels Capital, 1200, Belgium

  • Cooper University Health Care - Camden /ID# 258133

    Camden, New Jersey, 08103, United States

  • DCOL Center for Clinical Research /ID# 257093

    Longview, Texas, 75605, United States

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

    London, Greater London, SE1 9RT, United Kingdom

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

    Greenville, North Carolina, 27834, United States

  • Ezintsha Research Centre /ID# 257391

    Johannesburg, Gauteng, 2193, South Africa

  • Franco Felizarta, Md /Id# 256927

    Bakersfield, California, 93301, United States

  • HOPE Clinical Research /ID# 257487

    San Juan, 00909, Puerto Rico

  • Hospital Clinic de Barcelona /ID# 257269

    Barcelona, 08036, Spain

  • Hospital Universitario Germans Trias i Pujol /ID# 257268

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitario La Paz /ID# 257170

    Madrid, 28046, Spain

  • Hospital Universitario Ramon y Cajal /ID# 257266

    Madrid, 28034, Spain

  • Howard Brown Health Center /ID# 257485

    Chicago, Illinois, 60613-2010, United States

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

    Tokyo, 108-8639, Japan

  • IRCCS Ospedale San Raffaele /ID# 259820

    Milan, Milano, 20132, Italy

  • Infektiologikum /ID# 257112

    Frankfurt am Main, Hesse, 60596, Germany

  • Jacobi Medical Center /ID# 257849

    The Bronx, New York, 10461, United States

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

    Kansas City, Missouri, 64111, United States

  • Las Vegas Research Center /ID# 257619

    Las Vegas, Nevada, 89106, United States

  • Long Beach Education and Research Consultants /ID# 257552

    Long Beach, California, 90813-3267, United States

  • Los Angeles LGBT Center /ID# 258407

    Los Angeles, California, 90028-6213, United States

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

    Montreal, Quebec, H4A 3J1, Canada

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

    Decatur, Georgia, 30033, United States

  • Midland Florida Clinical Research Center /ID# 257101

    DeLand, Florida, 32720-0920, United States

  • Midway Immunology and Research Center /ID# 256930

    Ft. Pierce, Florida, 34982, United States

  • Montefiore Medical Center /ID# 257792

    The Bronx, New York, 10467, United States

  • NHO Nagoya Medical Center /ID# 261433

    Nagoya, Aichi-ken, 460-0001, Japan

  • National Hospital Organization Osaka National Hospital /ID# 261520

    Osaka, Osaka, 540-0006, Japan

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

    Dallas, Texas, 75246, United States

  • Optimus Medical /ID# 257182

    San Francisco, California, 94102, United States

  • Orlando Immunology Center /ID# 256931

    Orlando, Florida, 32803, United States

  • Ottawa Hospital Research Institute /ID# 256993

    Ottawa, Ontario, K1H 8L6, Canada

  • Palmtree Clinical Research Inc. /Id# 258409

    Palm Springs, California, 92262, United States

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

    Johannesburg, Gauteng, 2013, South Africa

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

    Dallas, Texas, 75208-4599, United States

  • Punkt Zdrowia /ID# 257950

    Gdansk, Pomeranian Voivodeship, 80-405, Poland

  • Quest Clinical Research /ID# 256928

    San Francisco, California, 94115-3037, United States

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

    Regina, Saskatchewan, S4P 0W5, Canada

  • Ricardo Diaz Scientific Solution /ID# 257335

    São Paulo, São Paulo, 04037-030, Brazil

  • Royal Free Hospital /ID# 257453

    London, Greater London, NW3 2QG, United Kingdom

  • Ruane Clinical Research Group /ID# 256932

    Los Angeles, California, 90036, United States

  • Saint Michael's Medical Center /ID# 258802

    Newark, New Jersey, 07102, United States

  • South Jersey Infectious Disease /ID# 257840

    Somers Point, New Jersey, 08244, United States

  • Spectrum Health Vancouver /ID# 260791

    Vancouver, British Columbia, V6Z 2T1, Canada

  • Suny Upstate University Hospital Community Campus /ID# 257847

    Syracuse, New York, 13215, United States

  • Texas Center for Infectious Disease Associates /ID# 257183

    Fort Worth, Texas, 76104, United States

  • The Crofoot Research Center, Inc /ID# 256921

    Houston, Texas, 77098-3900, United States

  • The Pierone Research Institute /ID# 257022

    Vero Beach, Florida, 32960-6541, United States

  • Toronto General Hospital /ID# 256994

    Toronto, Ontario, M5G 2C4, Canada

  • Triple O Research Institute /ID# 256929

    West Palm Beach, Florida, 33407, United States

  • UZ Gent /ID# 257446

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Universitaetsklinikum Bonn /ID# 257113

    Bonn, North Rhine-Westphalia, 53127, Germany

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

    Anderlecht, Brussels Capital, 1070, Belgium

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

    Birmingham, Alabama, 35222-2309, United States

  • University of Texas Southwestern Medical Center /ID# 257551

    Dallas, Texas, 75390-7208, United States

  • Unmhsc /Id# 257533

    Albuquerque, New Mexico, 87102-2612, United States

  • Washington Health Institute /ID# 259336

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

  • Winship At Emory University Hospital Midtown /ID# 258410

    Atlanta, Georgia, 30308, United States

  • Wisconsin Medical Center /ID# 257498

    Milwaukee, Wisconsin, 53226, United States

  • Wits RHI Research Centre /ID# 257354

    Johannesburg, Gauteng, 2001, South Africa

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

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

  • zibp-Zentrum fuer Infektiologie /ID# 257110

    Berlin, 10439, Germany