A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1
NCT ID: NCT04223804
Last Updated: 2023-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2020-01-30
2023-02-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Stage 1: Arm A
Participants will receive placebo.
Placebo
Intravenous (IV) infusion
Stage 1: Arm B
Participants will receive ABBV-181 dose A.
ABBV-181
Intravenous (IV) Infusion
Stage 1: Arm C
Participants will receive ABBV-181 dose B.
ABBV-181
Intravenous (IV) Infusion
Stage 2: Arm D
Participants will receive Placebo.
Placebo
Intravenous (IV) infusion
Stage 2: Arm E
Participants will receive ABBV-181 dose C.
ABBV-181
Intravenous (IV) Infusion
Interventions
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ABBV-181
Intravenous (IV) Infusion
Placebo
Intravenous (IV) infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Countries
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References
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Ramgopal MN, Lalezari JP, Pires Dos Santos AG, Krishnan P, Vaidya TR, Zhou F, Betman H, Dorr P, Mostafa NM, Alcaide ML, Felizarta F, Routy JP. Budigalimab, an anti-PD-1 inhibitor, for people living with HIV-1: a randomized, placebo-controlled phase 1b study. Nat Med. 2025 Oct 15. doi: 10.1038/s41591-025-03993-0. Online ahead of print.
Other Identifiers
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2019-004866-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M19-939
Identifier Type: -
Identifier Source: org_study_id
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