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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505900-53-00

Acronym

M19-965

Enrollment

Registered

2024-03-21

Start date

2024-04-08

Completion date

2025-09-08

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV infection

Brief summary

Viral control (viral load < 1000 copies/mL) at Week 24 without ART restart.

Detailed description

Peak viral load (at rebound) prior to re-starting ART., Time to first rebound to ≥ 1000 copies/mL during ART interruption.

Interventions

DRUGBudigalimab

DRUGPlacebo for Budigalimab (ABBV-181) - 0.9% Sodium Chloride or DILUENT

DRUGABBV-382

DRUGPlacebo for ABBV-382 Solution for Infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Viral control (viral load < 1000 copies/mL) at Week 24 without ART restart.	—

Secondary

Measure	Time frame
Peak viral load (at rebound) prior to re-starting ART., Time to first rebound to ≥ 1000 copies/mL during ART interruption.	—

Countries

Belgium, Denmark, France, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026