Last updated 6 days ago
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 or Subcutaneous (SC) Injection of Budigalimab and/or ABBV-382
160 patients around the world
Available in Puerto Rico, Brazil
AbbVie
1Research sites
160Patients around the world
This study is for people with
Hiv
Requirements for the patient
To 70 Years
All Gender
Medical requirements
- 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 a stable ART regimen for at least 8 weeks prior to screening (current ART regimen cannot include an Non-nucleoside reverse transcriptase inhibitor [NNRTI] or long-acting ART).Negative human immuno-deficiency virus (HIV)-2 antibody (Ab).Cluster of differentiation 4 (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.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.
- 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.History of CD4+ T cell nadir of <= 200 cells/μL 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.
Sites
Clinical Research Puerto Rico
Recruiting
SponsorAbbVie
Conditions
Hiv
Requirements
To 70 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06032546
