This study will be conducted in two stages and will test the safety/tolerability, pharmacokinetics (how the body handles study drug) and pharmacodynamics (effects on the immune system and the virus) of the study drug ABBV-181 in Human immunodeficiency virus (HIV)-1 infected participants undergoing Antiretroviral therapy (ART) interruption.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
41
Number of Participants with Study Drug-Related Adverse Events Grade 3 or Higher
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 44 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 NIH 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 44 weeks
Number of Participants with Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome
Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome.
Time frame: Up to approximately 44 weeks
Maximum Observed Concentration (Cmax)
Maximum Observed Concentration (Cmax) of ABBV-181.
Time frame: Up to approximately 36 weeks
Time to Cmax (Tmax)
Time to Cmax (Tmax) of ABBV-181.
Time frame: Up to approximately 36 weeks
Observed Concentration (Ctrough)
Observed Concentration (Ctrough) at the end of the dosing intervals for ABBV-181.
Time frame: Up to approximately 36 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Franco Felizarta, Md /Id# 215721
Bakersfield, California, United States
Ruane Clinical Research Group /ID# 224866
Los Angeles, California, United States
Quest Clinical Research /ID# 215796
San Francisco, California, United States
George Washington University Medical Faculty Associates /ID# 213893
Washington D.C., District of Columbia, United States
Midway Immunology and Research /ID# 215587
Ft. Pierce, Florida, United States
University of Miami, Miller School of Medicine /ID# 213833
Miami, Florida, United States
Orlando Immunology Center /ID# 243276
Orlando, Florida, United States
Triple O Research Institute /ID# 224863
West Palm Beach, Florida, United States
Be Well Medical Center /ID# 223841
Berkley, Michigan, United States
Mayo Clinic - Rochester /ID# 217820
Rochester, Minnesota, United States
...and 13 more locations
Area Under the Curve (AUCtau)
Area Under the Curve (AUCtau) during the dosing intervals for ABBV-181.
Time frame: Up to approximately 36 weeks
Half-life (t1/2)
Half-life (t1/2) of ABBV-181 following the last dose.
Time frame: Up to approximately 36 weeks