This study will evaluate how safe Budigalimab is and how it moves within the body in adult participants with HIV-1 infection. Budigalimab is an investigational drug being evaluated for the treatment of Human Immunodeficiency Virus. Study participants will be assigned to one of the 4 treatment groups and will receive a single dose of Budigalimab or placebo subcutaneous (SC) and intravenous (IV). Around 32 participants 18-65 years of age living with Human Immunodeficiency Virus will be enrolled in the study in approximately 9 sites worldwide. Each participant will receive single dose of SC and IV Budigalimab and/or Placebo on day 1 and will be followed for 24 weeks. Participants will attend weekly to every two and every four weeks visits during the study at a hospital. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects. There may be higher treatment burden for participants in this trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
33
Subcutaneous (SC)
Subcutaneous (SC)
Intravenous (IV)
Intravenous (IV)
Franco Felizarta, Md /Id# 223931
Bakersfield, California, United States
Ruane Clinical Research Group /ID# 224496
Los Angeles, California, United States
Quest Clinical Research /ID# 223925
San Francisco, California, United States
Central Texas Clinical Research /ID# 223937
Austin, Texas, United States
St. Hope Foundation, Inc. /ID# 224492
Bellaire, Texas, United States
North TX Infectious Diseases /ID# 224494
Dallas, Texas, United States
The Crofoot Research Center, Inc /ID# 224493
Houston, Texas, United States
Peter Shalit, M.D. /ID# 224801
Seattle, Washington, United States
Ponce Medical School Foundation /ID# 224230
Ponce, Puerto Rico
Puerto Rico AIDS Clinical Trials Unit CRS /ID# 223936
San Juan, Puerto Rico
Number of Participants Experiencing Study Drug-Related Grade 3 or Higher Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of the study drug as either having a reasonable possibility or no reasonable possibility. AEs are given a grade from 1-5 with Grade 3 being severe but not life-threatening and requiring hospitalization, Grade 4 being life-threatening requiring immediate intervention and Grade 5 being death related to an AE.
Time frame: Up to approximately 24 weeks
Number of Participants With Study Drug-Related Immune-Related Adverse Events (IRAE)
Assessed using the American Society of Clinical Oncology (ASCO) IRAE management guidelines \[which utilizes the National Institutes of Health (NIH) Common Terminology Criteria for Adverse Events (CTCAE) grading scale\] but modified, as applicable, according to the NIH Division of AIDS (DAIDS) (v2.1) AE grading scale.
Time frame: Up to approximately 24 weeks
Maximum Serum Concentration (Cmax)
Maximum Serum Concentration (Cmax) of Budigalimab.
Time frame: Up to approximately 24 weeks
Time to Maximum Observed Plasma Concentration (Tmax)
Time to Maximum Observed Plasma Concentration (Tmax) of Budigalimab.
Time frame: Up to approximately 24 weeks
Area Under the Plasma Concentration-time Curve (AUC) of Budigalimab in Plasma
Area Under the Plasma Concentration-time Curve (AUC).
Time frame: Up to approximately 24 weeks
Terminal Phase Elimination Half-life (t1/2) of Budigalimab in Plasma
Terminal phase elimination half-life (t1/2)
Time frame: Up to approximately 24 weeks.
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