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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Zelalem Temesgen, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Información adicional de contacto

Formulario de contacto para ensayos que no son sobre cáncer

Teléfono: 800-664-4542 (llamada gratis)

Preguntas de estudios clínicos para pacientes internacionales