A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living with Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion of Budigalimab and/or ABBV-382

JRCT ID: jRCT2051230193

Registered date:29/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Human immuno-deficiency virus (HIV) Disease
• Date of first enrollment: 29/03/2024
• Target sample size: 140
• Countries of recruitment: Belgium,Japan,United Kingdom,Japan,Italy,Japan,Brazil,Japan,United States,Japan,Canada,Japan,France,Japan,Spain,Japan,Germany,Japan,Sweden,Japan,South Africa,Japan,Poland,Japan,Denmark,Japan,Puerto Rico,Japan
• Study type: Interventional

Intervention(s)

Budigalimab IV
Placebo for Budigalimab IV
ABBV-382 IV
Placebo for ABBV-382 IV

Outcome(s)

• Primary Outcome: Percentage of participants who achieve viral control (viral load < 1000 copies/mL) without ART restart at Week 24.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 70age old
• Gender: Both

Include 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 current ART regimen for at least 8 weeks prior to screening (current ART regimen cannot include an Non-nucleoside reverse transcriptase inhibitor [NNRTI]).
-Negative human immuno-deficiency virus (HIV)-2 antibody (Ab)
-CD4+ T cell count >= 500 cells/L at screening and no known evidence of CD4+ T cell count < 500 cells/L 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

Exclude criteria

-Prior exposure to long acting antiretrovirals within 24weeks 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 cluster of differentiation 4 (CD4+) T cell nadir of <= 200 cells/L 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.

Related Information

• Primary Sponsor: Tetsuya Otani
• Secondary ID(s): NCT06032546