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)

Study Identifier
M19-966
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact
Study Complete

Study Details

Medical Condition
  • Human Immunodeficiency Virus (HIV)
  • Study Drug
  • ABBV-382
  • Placebo for ABBV-382
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 65 Years

    Protocol Summary

    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 Locations

    Location
    Status
    Location
    Franco Felizarta, Md /Id# 223815
    Bakersfield, California, United States, 93301
    Status
    Not applicable
    Location
    Ruane Clinical Research Group /ID# 224125
    Los Angeles, California, United States, 90036
    Status
    Not applicable
    Location
    Quest Clinical Research /ID# 223347
    San Francisco, California, United States, 94115-3037
    Status
    Not applicable
    Location
    George Washington University Medical Faculty Associates /ID# 223493
    Washington D.C., District of Columbia, United States, 20037-3201
    Status
    Not applicable
    Location
    Midway Immunology and Research Center /ID# 223500
    Ft. Pierce, Florida, United States, 34982
    Status
    Not applicable
    Location
    Orlando Immunology Center /ID# 223498
    Orlando, Florida, United States, 32803
    Status
    Not applicable
    Showing {first} - {last} of {total} Results