Summary

for people ages 18-65 (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

Summary

This study will be conducted in two stages and will test 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 ART interruption.

Official Title

A Randomized, Double-blind, Placebo-controlled, Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of ABBV-181 in HIV-1 Infected Adults

Keywords

Human Immunodeficiency Virus (HIV) HIV Infection HIV-1 ABBV-181 Analytical Treatment Interruption Budigalimab PD-1 Anti-PD-1 Antibody HIV Infections Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes

Eligibility

You can join if…

Open to people ages 18-65

  • Body Mass Index (BMI) ≥ 18.0 to <35 kg/m2
  • 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

You CAN'T join if...

  • 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

Locations

  • Univ California, San Francisco /ID# 215577 not yet accepting patients
    San Francisco California 94143-2204 United States
  • Quest Clinical Research /ID# 215796 not yet accepting patients
    San Francisco California 94115-3037 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT04223804
Phase
Phase 1
Study Type
Interventional
Last Updated