Study to Assess Adverse Events and How Intravenous (IV) or Subcutaneous (SC) ABBV-382 Moves Through the Body of Adult Participants With Human Immuno-Deficiency Virus (HIV-1)
Human Immunodeficiency Virus (HIV)
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus (HIV) focused on measuring Human Immunodeficiency Virus, HIV, HIV-1, ABBV-382
Eligibility Criteria
Inclusion Criteria:
- Body Mass Index (BMI) is >= 18.0 to <= 35.0 kg/m^2 after rounding to the tenths decimal.
- Must agree to use effective barrier protection during sexual activity for protection against Human Immunodeficiency Virus (HIV)-1 transmission through the last study visit.
- Female participants of childbearing potential must give consent to abide by contraception requirements.
- CD4+ count of >= 350 cells/μL at screening and at least once during the 48 weeks prior to screening.
- Negative screen for drugs of abuse and alcohol at screening. Participants with a positive marijuana screen may be included after evaluation by the investigator that the use would not interfere with adherence to study requirements, and that usage is not on a regular or chronic basis.
- Laboratory values must meet the acceptable criteria.
Part A participants must also have:
- Positive test result for anti-HIV antibody at screening.
- Plasma HIV-1 ribose nucleic acid (RNA) between 1,000 - 200,000 copies/mL at screening.
- Must be naive to combination antiretroviral therapy (cART) or have been off of cART for > 12 weeks or 5 half-lives of the drug (whichever is longer) prior to screening with documentation of at least one plasma HIV-1 RNA measurement greater than or equal to the lower limit of quantification (LLOQ) during the off cART period.
- Willing to hold on initiation of cART throughout the screening period and until 4 weeks after dosing.
Part B participants must also have:
- Positive test result for anti-HIV antibody at screening.
- Must have plasma HIV-1 RNA below the lower limit of quantification at screening and at least 24 weeks prior to screening. A single unconfirmed "blip" is allowed if preceded and followed by values below the lower limit of quantification.
- Must be HIV-1 infected on cART for at least 48 weeks prior to screening and on current cART regimen for at least 12 weeks prior to screening.
Exclusion Criteria:
- Female participants who are pregnant, breastfeeding, or considering becoming pregnant during the study.
- History or ongoing diagnosis of acquired immune deficiency syndrome (AIDS)-defining illness.
- History of or active immunodeficiency (other than HIV).
- Active autoimmune disease or history of autoimmune disease that has required systemic treatment.
- Clinically significant medical disorders (other than HIV-1 infection) that might expose the participant to undue risk of harm, confound study outcomes, or prevent the participant from completing the study.
- Active or suspected malignancy or history of malignancy (other than basal cell skin cancer or cervical carcinoma in situ) in the past 5 years.
- History or evidence of active tuberculosis (TB) disease or untreated latent TB infection at screening.
- No history of positive TB skin test or interferon gamma release assay (IGRA) or at screening which is considered clinically significant by the investigator. Participant with a history of a positive TB skin test or IGRA or at screening must have documentation of completion of a Centers for Disease Control and Prevention (CDC) recommended treatment course for latent TB. Any participant with suspicion for or diagnosis of active TB is excluded.
- Known psychiatric or substance abuse disorders that would interfere with adherence to study requirements.
- Currently enrolled in another interventional clinical study.
- Received immunomodulatory or immunosuppressive (including intravenous [IV]/oral [PO] steroids at any dose, but excluding steroids that are inhaled or topical) therapy within 24 weeks prior to the first dose of study drug.
Sites / Locations
- Franco Felizarta, Md /Id# 223815
- Ruane Clinical Research Group /ID# 224125
- Quest Clinical Research /ID# 223347
- George Washington University Medical Faculty Associates /ID# 223493
- Midway Immunology and Research Center /ID# 223500
- Orlando Immunology Center /ID# 223498
- St. Joseph Comprehensive Research Institute /ID# 246232
- Triple O Research Institute /ID# 223460
- CenExcel iResearch LLC /ID# 225526
- Infinite Clinical Trials - Morrow /ID# 225455
- University of Iowa Hospitals and Clinics /ID# 224267
- Be Well Medical Center /ID# 223381
- North Shore University Hospital Manhasset /ID# 223343
- The Christ Hospital /ID# 224871
- Central Texas Clinical Research /ID# 223378
- Prism Health North Texas - Oak Cliff Health Center /ID# 223237
- North Texas Infectious Diseases Consultants, P.A /ID# 223236
- The Crofoot Research Center, Inc /ID# 223383
- Peter Shalit, M.D. /ID# 224252
- Ponce Medical School Foundation /ID# 224231
- Clinical Research Puerto Rico /ID# 223923
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Part A: ABBV-382 Dose A
Part A: ABBV-382 Dose B
Part B: Intravenous Cohort: ABBV-382 Dose A
Part B: Intravenous Cohort: Placebo for ABBV-382 Dose A
Part B: Intravenous Cohort: ABBV-382 Dose B
Part B: Intravenous Cohort: Placebo for ABBV-382 Dose B
Part B: Subcutaneous Cohort: ABBV-382
Participants will receive intravenous (IV) ABBV-382 dose A on Day 1.
Participants will receive intravenous (IV) ABBV-382 dose B on Day 1.
Participants will receive intravenous (IV) ABBV-382 dose A on Days 1, 29 and 57.
Participants will receive intravenous (IV) placebo for ABBV-382 dose A on Days 1, 29 and 57.
Participants will receive intravenous (IV) ABBV-382 dose B on Days 1, 29 and 57.
Participants will receive intravenous (IV) placebo for ABBV-382 dose B on Days 1, 29 and 57.
Participants will receive subcutaneous (SC) ABBV-382 dose C on Days 1, 29 and 57.