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

Completed · Phase 1 · Has a placebo group

Conditions studied: Human Immunodeficiency Virus (HIV), HIV Infection, HIV-1

In brief

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 Human immunodeficiency virus (HIV)-1 infected participants undergoing Antiretroviral therapy (ART) interruption.

Key facts

Study ID

NCT04223804

Run by

AbbVie

People needed

41

Starts

2020-01-30

Expected to finish

2023-02-27

Last updated by the study team

2023-03-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Body Mass Index (BMI) between 18.0 and 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 8 weeks prior to screening.
• Meets HIV-specific laboratory parameters as below:
• Plasma HIV-1 RNA below lower limit of quantification (LLOQ) 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 >= 200 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 may not qualify if…

• Known resistance to at least 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 24 weeks prior to the first dose of study drug.
• Prior therapy/exposure to ABBV-181 or any other immune checkpoint inhibitor.
• Current hepatitis B virus or hepatitis C virus infection.
• Clinically significant medical disorders that might expose the participants to undue risk of harm, confound study outcomes, or prevent the participant from completing the study (including but not limited to significant or unstable cardiac, neurologic or pulmonary disease, chronic active infectious disease except for HIV, chronic liver disease, poorly controlled diabetes mellitus and history of Stevens Johnson Syndrome toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS)).
• Known psychiatric or substance abuse disorders that would interfere with adherence to study requirements.
• Female participants must not be pregnant, breastfeeding, or considering becoming pregnant during the study.

Where it is running

• Franco Felizarta, Md /Id# 215721 — Bakersfield, California, United States
• Ruane Clinical Research Group /ID# 224866 — Los Angeles, California, United States
• Quest Clinical Research /ID# 215796 — San Francisco, California, United States
• George Washington University Medical Faculty Associates /ID# 213893 — Washington D.C., District of Columbia, United States
• Midway Immunology and Research /ID# 215587 — Ft. Pierce, Florida, United States
• University of Miami, Miller School of Medicine /ID# 213833 — Miami, Florida, United States
• Orlando Immunology Center /ID# 243276 — Orlando, Florida, United States
• Triple O Research Institute /ID# 224863 — West Palm Beach, Florida, United States
• Be Well Medical Center /ID# 223841 — Berkley, Michigan, United States
• Mayo Clinic - Rochester /ID# 217820 — Rochester, Minnesota, United States
• Saint Michael's Medical Center /ID# 228733 — Newark, New Jersey, United States
• University of Cincinnati /ID# 215615 — Cincinnati, Ohio, United States
• Prism Health North Texas - Oak Cliff Health Center /ID# 214036 — Dallas, Texas, United States
• North TX Infectious Diseases /ID# 224861 — Dallas, Texas, United States
• Peter Shalit, M.D. /ID# 224870 — Seattle, Washington, United States
• Holdsworth House Medical Practice /ID# 215352 — Darlinghurst, New South Wales, Australia
• St Vincent's Hospital Sydney /ID# 215354 — Darlinghurst, New South Wales, Australia
• The Royal Melbourne Hospital /ID# 215351 — Parkville, Victoria, Australia
• Ottawa Hospital Research Institute /ID# 218083 — Ottawa, Ontario, Canada
• Toronto General Hospital /ID# 218082 — Toronto, Ontario, Canada
• McGill Univ Clinical Research /ID# 218081 — Montreal, Quebec, Canada
• Clinical Research Puerto Rico /ID# 218821 — San Juan, Puerto Rico
• Puerto Rico AIDS Clinical Trials Unit CRS /ID# 213761 — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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