Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT04223804
Status:
COMPLETED
Last Update Posted:
2023-03-09
First Post:
2020-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719868', 'term': 'budigalimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-07', 'studyFirstSubmitDate': '2020-01-08', 'studyFirstSubmitQcDate': '2020-01-08', 'lastUpdatePostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Study Drug-Related Adverse Events Grade 3 or Higher', 'timeFrame': 'Up to approximately 44 weeks', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of the study drug as either having a reasonable possibility or no reasonable possibility. AEs are given a grade from 1-5 with Grade 3 being severe but not life-threatening and requiring hospitalization, Grade 4 being life-threatening requiring immediate intervention and Grade 5 being death related to an AE.'}, {'measure': 'Number of Participants with Study Drug-Related Immune-Related Adverse Events (IRAE)', 'timeFrame': 'Up to approximately 44 weeks', 'description': 'Assessed using the American Society of Clinical Oncology (ASCO) IRAE management guidelines (which utilizes the NIH CTCAE grading scale) but modified, as applicable, according to the NIH Division of AIDS (DAIDS) (v2.1) AE grading scale.'}, {'measure': 'Number of Participants with Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome', 'timeFrame': 'Up to approximately 44 weeks', 'description': 'Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome.'}, {'measure': 'Maximum Observed Concentration (Cmax)', 'timeFrame': 'Up to approximately 36 weeks', 'description': 'Maximum Observed Concentration (Cmax) of ABBV-181.'}, {'measure': 'Time to Cmax (Tmax)', 'timeFrame': 'Up to approximately 36 weeks', 'description': 'Time to Cmax (Tmax) of ABBV-181.'}, {'measure': 'Observed Concentration (Ctrough)', 'timeFrame': 'Up to approximately 36 weeks', 'description': 'Observed Concentration (Ctrough) at the end of the dosing intervals for ABBV-181.'}, {'measure': 'Area Under the Curve (AUCtau)', 'timeFrame': 'Up to approximately 36 weeks', 'description': 'Area Under the Curve (AUCtau) during the dosing intervals for ABBV-181.'}, {'measure': 'Half-life (t1/2)', 'timeFrame': 'Up to approximately 36 weeks', 'description': 'Half-life (t1/2) of ABBV-181 following the last dose.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Human Immunodeficiency Virus (HIV)', 'HIV Infection', 'HIV-1', 'ABBV-181', 'Analytical Treatment Interruption', 'Budigalimab', 'Programmed cell death protein-1 (PD-1)', 'Anti-PD-1 Antibody'], 'conditions': ['Human Immunodeficiency Virus (HIV)', 'HIV Infection', 'HIV-1']}, 'referencesModule': {'references': [{'pmid': '41094034', 'type': 'DERIVED', 'citation': '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 Nov;31(11):3879-3888. doi: 10.1038/s41591-025-03993-0. Epub 2025 Oct 15.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) between 18.0 and 35 kg/m2.\n* 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.\n* Meets HIV-specific laboratory parameters as below:\n\n * Plasma HIV-1 RNA below lower limit of quantification (LLOQ) at screening and at least 6 months prior to screening.\n * CD4+ T cell count \\>= 500 cells/uL at screening and at least once during the 12 months prior to screening.\n * CD4+ T cell nadir of \\>= 200 cells/uL during chronic infection.\n* Willing to undergo ART interruption.\n* 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.\n\nExclusion Criteria:\n\n* Known resistance to at least 2 classes of ART.\n* History of AIDS-defining illness.\n* Active or suspected malignancy or history of malignancy (other than basal cell skin cancer or cervical carcinoma in situ) in the past 5 years.\n* History of or active immunodeficiency (other than HIV).\n* Active autoimmune disease or history of autoimmune disease that has required systemic treatment.\n* 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.\n* Prior therapy/exposure to ABBV-181 or any other immune checkpoint inhibitor.\n* Current hepatitis B virus or hepatitis C virus infection.\n* 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)).\n* Known psychiatric or substance abuse disorders that would interfere with adherence to study requirements.\n* Female participants must not be pregnant, breastfeeding, or considering becoming pregnant during the study.'}, 'identificationModule': {'nctId': 'NCT04223804', 'briefTitle': 'A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'M19-939'}, 'secondaryIdInfos': [{'id': '2019-004866-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Stage 1: Arm A', 'description': 'Participants will receive placebo.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1: Arm B', 'description': 'Participants will receive ABBV-181 dose A.', 'interventionNames': ['Drug: ABBV-181']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1: Arm C', 'description': 'Participants will receive ABBV-181 dose B.', 'interventionNames': ['Drug: ABBV-181']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Stage 2: Arm D', 'description': 'Participants will receive Placebo.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2: Arm E', 'description': 'Participants will receive ABBV-181 dose C.', 'interventionNames': ['Drug: ABBV-181']}], 'interventions': [{'name': 'ABBV-181', 'type': 'DRUG', 'otherNames': ['Budigalimab'], 'description': 'Intravenous (IV) Infusion', 'armGroupLabels': ['Stage 1: Arm B', 'Stage 1: Arm C', 'Stage 2: Arm E']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Intravenous (IV) infusion', 'armGroupLabels': ['Stage 1: Arm A', 'Stage 2: Arm D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93301', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Franco Felizarta, Md /Id# 215721', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ruane Clinical Research Group /ID# 224866', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94115-3037', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Quest Clinical Research /ID# 215796', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20037-3201', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington University Medical Faculty Associates /ID# 213893', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '34982', 'city': 'Ft. Pierce', 'state': 'Florida', 'country': 'United States', 'facility': 'Midway Immunology and Research /ID# 215587', 'geoPoint': {'lat': 27.44671, 'lon': -80.32561}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami, Miller School of Medicine /ID# 213833', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Immunology Center /ID# 243276', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33407-3100', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Triple O Research Institute /ID# 224863', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '48072-3046', 'city': 'Berkley', 'state': 'Michigan', 'country': 'United States', 'facility': 'Be Well Medical Center /ID# 223841', 'geoPoint': {'lat': 42.50309, 'lon': -83.18354}}, {'zip': '55905-0001', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic - Rochester /ID# 217820', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '07102', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': "Saint Michael's Medical Center /ID# 228733", 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '45267-0585', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati /ID# 215615', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '75208-4599', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Prism Health North Texas - Oak Cliff Health Center /ID# 214036', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'North TX Infectious Diseases /ID# 224861', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98104-3595', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Peter Shalit, M.D. /ID# 224870', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Holdsworth House Medical Practice /ID# 215352', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': "St Vincent's Hospital Sydney /ID# 215354", 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '3050', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Royal Melbourne Hospital /ID# 215351', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Hospital Research Institute /ID# 218083', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital /ID# 218082', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2X 2P4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill Univ Clinical Research /ID# 218081', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '00909', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Clinical Research Puerto Rico /ID# 218821', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00935', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Puerto Rico AIDS Clinical Trials Unit CRS /ID# 213761', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}