A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With HIV-1

Overview

About this study

The purpose of this study is to test (in 2 stages) 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 HIV-1 infected participants undergoing antiretroviral therapy (ART) interruption.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Body Mass Index (BMI) ≥ 18.0 to < 35 kg/m^2.
  • HIV-1 infected on antiretroviral therapy (ART) for at least 12 months prior to screening and on current ART regimen for at least 12 weeks prior to screening.
  • Meets HIV-specific laboratory parameters as below:
    • Plasma HIV-1 RNA below lower limit of detection (LLOD) at screening and at least 6 months prior to screening;
    • CD4+ T cell count ≥ 500 cells/uL at screening and at least once during the 12 months prior to screening;
    • CD4+ T cell nadir of ≥ 350 cells/uL during chronic infection.
  • Willing to undergo ART interruption.
  • Agrees to use an effective barrier method of protection (male and/or female condoms) during sexual activity for protection against HIV-1 transmission throughout the entire study

Exclusion Criteria:

  • Known resistance to ≥ 2 classes of ART.
  • History of AIDS-defining illness.
  • 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 of or active immunodeficiency (other than HIV).
  • Active autoimmune disease or history of autoimmune disease that has required systemic treatment.
  • Prior receipt of immunomodulatory or immunosuppressive (including intravenous infusion or oral steroids at any dose, but excluding steroids that are inhaled, topical or by local injection) therapy within 6 months prior to the first dose of study drug.
  • Current hepatitis B virus or hepatitis C virus infection.
  • Female participants must not be pregnant, breastfeeding, or considering becoming pregnant during the study.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Andrew Badley, M.D.

Contact us for the latest status

Contact information:

Department of Medicine - Clinical Trials Unit

(507) 266-1944

RSTDOMCTU@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available