Status:
TERMINATED
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
Lead Sponsor:
AbbVie
Conditions:
Human Immuno-deficiency Virus (HIV) Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency Syndrome (AIDS). HIV disease is considered to be a chronic disease requiring lifelong therapy. The purpose of th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2025
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT06032546
Start Date
October 12 2023
End Date
September 22 2025
Last Update
October 29 2025
Active Locations (80)
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1
University of Alabama at Birmingham, 1917 Research Clinic /ID# 257549
Birmingham, Alabama, United States, 35222-2309
2
Franco Felizarta, Md /Id# 256927
Bakersfield, California, United States, 93301
3
AHF Research Center /ID# 257025
Beverly Hills, California, United States, 90211
4
Long Beach Education and Research Consultants /ID# 257552
Long Beach, California, United States, 90813-3267