Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency Syndrome (AIDS). HIV infection is considered to be a chronic disease requiring lifelong therapy. This study will evaluate how safe ABBV-382 is and how it is absorbed, distributed and eliminated from the body in adult participants with HIV-1 infection. ABBV-382 is an investigational drug being developed for the treatment of HIV-1 infection. This study takes place in 2 parts. In Part A, participants with HIV-1 and no history of combination antiretroviral therapy (cART) or who are off cART for more than 3 months will be enrolled to receive ABBV-382. In Part B, participants with no virus in their blood and on maintenance cART will be enrolled into one of the intravenous (IV) or subcutaneous (SC) groups. In the IV groups, participants will receive either placebo or ABBV-382 whereas participants in the SC group will receive ABBV-382. There is 1 in 3 chance that participants will receive placebo (no drug) in Part B IV groups. The IV group in Part B is double-blinded which means neither the study doctors nor the participants will know who will be given study drug or placebo. Around 52 adult participants with HIV-1 infection will be enrolled at approximately 21 sites across the United States, including Puerto Rico. Participants in Part A will receive an intravenous (IV) dose of ABBV-382 on Day 1. Participants in Part B will receive an IV or SC dose of ABBV-382 or placebo on Days 1, 29 and 57. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and presence of side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
54
Franco Felizarta, Md /Id# 223815
Bakersfield, California, United States
Ruane Clinical Research Group /ID# 224125
Los Angeles, California, United States
Quest Clinical Research /ID# 223347
San Francisco, California, United States
George Washington University Medical Faculty Associates /ID# 223493
Washington D.C., District of Columbia, United States
Midway Immunology and Research Center /ID# 223500
Ft. Pierce, Florida, United States
Orlando Immunology Center /ID# 223498
Orlando, Florida, United States
St. Joseph Comprehensive Research Institute /ID# 246232
Tampa, Florida, United States
Triple O Research Institute /ID# 223460
West Palm Beach, Florida, United States
CenExcel iResearch LLC /ID# 225526
Decatur, Georgia, United States
Infinite Clinical Trials - Morrow /ID# 225455
Morrow, Georgia, United States
...and 11 more locations
Incidence of 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 study drug as either "Reasonable Possibility" or "No Reasonable Possibility" and will assess the severity of each adverse event from Grade 1 (mild) to Grade 4 (potentially life-threatening).
Time frame: Up to Day 255
Maximum Observed Serum Concentration (Cmax) of ABBV-382 (Part A and Part B)
Maximum observed serum concentration (Cmax) of ABBV-382.
Time frame: Up to Day 225
Time to Cmax (Tmax) of ABBV-382 (Part A and Part B)
Time to Cmax (Tmax) of ABBV-382.
Time frame: Up to Day 225
Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-382 (Part A)
Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) of ABBV-382.
Time frame: Up to Day 112
Area Under the Serum Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-382 (Part A)
AUC from time 0 to infinite time (AUCinf) of ABBV-382.
Time frame: Up to Day 112
Terminal Phase Elimination Rate Constant (β) of ABBV-382 (Part A)
Terminal phase elimination rate constant of ABBV-382.
Time frame: Up to Day 112
Terminal Phase Elimination Half-Life (t1/2) of ABBV-382 (Part A)
Terminal phase elimination half-life of ABBV-382.
Time frame: Up to Day 112
Observed Concentration at the End of the 4-Week Dosing Interval (Ctrough) of ABBV-382 (Part B)
Observed concentration at the end of the 4-week dosing interval (Ctrough) of ABBV-382.
Time frame: Up to Day 225
AUC During the 4-Week Dosing Interval (AUCtau) of ABBV-382 (Part B)
AUC during the 4-week dosing interval (AUCtau) of ABBV-382.
Time frame: Up to Day 225
Terminal Phase Elimination Half-Life (t1/2) of ABBV-382 (Part B)
Terminal phase elimination half-life (t1/2) of ABBV-382 will be estimated after the third dose only.
Time frame: Day 57 to Day 225
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