HIV: Budigalimab and/or ABBV-382 in People Living with HIV on Stable Antiretroviral Therapy

Phase 1

Recruiting

• Conditions: HIV infection; MedDRA version: 20.1Level: PTClassification code: 10020161Term: HIV infection Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: CTIS2023-505900-53-00
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-21
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

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.

Exclusion Criteria

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., 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified