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)

Launched by ABBVIE · Sep 14, 2020

Keywords

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Gender

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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.