NCT06032546CompletedPhase 2
HIV: Budigalimab and/or ABBV-382 in People Living with HIV on Stable Antiretroviral Therapy
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.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 15 Sept 2025
Brief summary (registry, in English)
To evaluate efficacy, safety, tolerability, and PK of budigalimab and/or ABBV-382 versus placebo in PLWH on stable ART undergoing ATI.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (actual)
- First submitted
- 21 Nov 2023
- Start date
- 8 Apr 2024
- Lead sponsor
- AbbVie Deutschland GmbH & Co. KG
- Diseases
- HIV
- NCT number
- NCT06032546
- EU CT number
- 2023-505900-53-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 32
- 20 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants that have had 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.
Other illness
- Participants have known history of CD4+ T cell nadir of ≤ 200 cells/μL during chronic HIV infection.
- Participants with clinically significant medical disorders per investigator's assessment that might expose the participants to undue risk of harm, confound study outcomes, or prevent the participant from completing the study.
Who the study is looking for
- PLWH between 18-70 years old, in general good health and on ART for at least 12 months prior to screening and on current ART regimen for at least 8 weeks prior to screening.
- Participants must have negative HIV-2 Ab at screening; plasma HIV-1 RNA below LLOQ at screening and for at least 12 months prior to screening; and 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Completed |
| CHU Saint-Pierre Coordinator of this site? Confirm its status | Brussels | Belgium | Completed |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Completed |
| zibp Zentrum fuer Infektiologie Berlin Prenzlauer Berg GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Completed |
| Hvidovre Hospital Coordinator of this site? Confirm its status | Hvidovre | Denmark | Completed |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Completed |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hopital Saint Antoine Coordinator of this site? Confirm its status | Paris Cedex 12 | France | Completed |
| Hopital Tenon Coordinator of this site? Confirm its status | Paris Cedex 20 | France | Completed |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Completed |
| Azienda Ospedaliera Universitaria Federico II Di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Wojewodzki Szpital Obserwacyjno-Zakazny Im Tadeusza Browicza Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Punkt Zdrowia Hlebowicz Jakubowski Lekarze sp. p. Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.