Fact CheckerSign in

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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hopital Erasme
Coordinator of this site? Confirm its status
AnderlechtBelgiumCompleted
CHU Saint-Pierre
Coordinator of this site? Confirm its status
BrusselsBelgiumCompleted
Universitair Ziekenhuis Gent
Coordinator of this site? Confirm its status
GentBelgiumCompleted
Cliniques Universitaires Saint-Luc
Coordinator of this site? Confirm its status
Sint-Lambrechts-WoluweBelgiumCompleted
zibp Zentrum fuer Infektiologie Berlin Prenzlauer Berg GmbH
Coordinator of this site? Confirm its status
BerlinGermanyCompleted
Aalborg University Hospital
Coordinator of this site? Confirm its status
AalborgDenmarkCompleted
Hvidovre Hospital
Coordinator of this site? Confirm its status
HvidovreDenmarkCompleted
Odense University Hospital
Coordinator of this site? Confirm its status
Odense CDenmarkCompleted
Hospital Germans Trias i Pujol
Coordinator of this site? Confirm its status
BadalonaSpainCompleted
Hospital Clinic de Barcelona
Coordinator of this site? Confirm its status
BarcelonaSpainCompleted
Hospital Universitario La Paz
Coordinator of this site? Confirm its status
MadridSpainCompleted
Hospital Universitario Ramón y Cajal
Coordinator of this site? Confirm its status
MadridSpainCompleted
Hopital Saint Antoine
Coordinator of this site? Confirm its status
Paris Cedex 12FranceCompleted
Hopital Tenon
Coordinator of this site? Confirm its status
Paris Cedex 20FranceCompleted
ASST Grande Ospedale Metropolitano Niguarda
Coordinator of this site? Confirm its status
MilanItalyCompleted
Ospedale San Raffaele S.r.l.
Coordinator of this site? Confirm its status
MilanItalyCompleted
Azienda Ospedaliero - Universitaria di Modena
Coordinator of this site? Confirm its status
ModenaItalyCompleted
Azienda Ospedaliera Universitaria Federico II Di Napoli
Coordinator of this site? Confirm its status
NaplesItalyCompleted
Wojewodzki Szpital Obserwacyjno-Zakazny Im Tadeusza Browicza
Coordinator of this site? Confirm its status
BydgoszczPolandCompleted
Punkt Zdrowia Hlebowicz Jakubowski Lekarze sp. p.
Coordinator of this site? Confirm its status
GdanskPolandCompleted

This page is information, not medical advice. Discuss any trial with your doctor.