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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004866-16 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1: Arm A | Placebo Comparator | Participants will receive placebo. |
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| Stage 1: Arm B | Experimental | Participants will receive ABBV-181 dose A. |
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| Stage 1: Arm C | Experimental | Participants will receive ABBV-181 dose B. |
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| Stage 2: Arm D | Placebo Comparator | Participants will receive Placebo. |
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| Stage 2: Arm E | Experimental | Participants will receive ABBV-181 dose C. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-181 | Drug | Intravenous (IV) Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Study Drug-Related Adverse Events Grade 3 or Higher | 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. | Up to approximately 44 weeks |
| Number of Participants with Study Drug-Related Immune-Related Adverse Events (IRAE) | 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. | Up to approximately 44 weeks |
| Number of Participants with Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome | Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome. | Up to approximately 44 weeks |
| Maximum Observed Concentration (Cmax) | Maximum Observed Concentration (Cmax) of ABBV-181. | Up to approximately 36 weeks |
| Time to Cmax (Tmax) | Time to Cmax (Tmax) of ABBV-181. | Up to approximately 36 weeks |
| Observed Concentration (Ctrough) |
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Inclusion Criteria:
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franco Felizarta, Md /Id# 215721 | Bakersfield | California | 93301 | United States | ||
| Ruane Clinical Research Group /ID# 224866 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41094034 | Derived | 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. |
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| Placebo | Drug | Intravenous (IV) infusion |
|
Observed Concentration (Ctrough) at the end of the dosing intervals for ABBV-181.
| Up to approximately 36 weeks |
| Area Under the Curve (AUCtau) | Area Under the Curve (AUCtau) during the dosing intervals for ABBV-181. | Up to approximately 36 weeks |
| Half-life (t1/2) | Half-life (t1/2) of ABBV-181 following the last dose. | Up to approximately 36 weeks |
| Los Angeles |
| California |
| 90036 |
| United States |
| Quest Clinical Research /ID# 215796 | San Francisco | California | 94115-3037 | United States |
| George Washington University Medical Faculty Associates /ID# 213893 | Washington D.C. | District of Columbia | 20037-3201 | United States |
| Midway Immunology and Research /ID# 215587 | Ft. Pierce | Florida | 34982 | United States |
| University of Miami, Miller School of Medicine /ID# 213833 | Miami | Florida | 33136 | United States |
| Orlando Immunology Center /ID# 243276 | Orlando | Florida | 32803 | United States |
| Triple O Research Institute /ID# 224863 | West Palm Beach | Florida | 33407-3100 | United States |
| Be Well Medical Center /ID# 223841 | Berkley | Michigan | 48072-3046 | United States |
| Mayo Clinic - Rochester /ID# 217820 | Rochester | Minnesota | 55905-0001 | United States |
| Saint Michael's Medical Center /ID# 228733 | Newark | New Jersey | 07102 | United States |
| University of Cincinnati /ID# 215615 | Cincinnati | Ohio | 45267-0585 | United States |
| Prism Health North Texas - Oak Cliff Health Center /ID# 214036 | Dallas | Texas | 75208-4599 | United States |
| North TX Infectious Diseases /ID# 224861 | Dallas | Texas | 75246 | United States |
| Peter Shalit, M.D. /ID# 224870 | Seattle | Washington | 98104-3595 | United States |
| Holdsworth House Medical Practice /ID# 215352 | Darlinghurst | New South Wales | 2010 | Australia |
| St Vincent's Hospital Sydney /ID# 215354 | Darlinghurst | New South Wales | 2010 | Australia |
| The Royal Melbourne Hospital /ID# 215351 | Parkville | Victoria | 3050 | Australia |
| Ottawa Hospital Research Institute /ID# 218083 | Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto General Hospital /ID# 218082 | Toronto | Ontario | M5G 2C4 | Canada |
| McGill Univ Clinical Research /ID# 218081 | Montreal | Quebec | H2X 2P4 | Canada |
| Clinical Research Puerto Rico /ID# 218821 | San Juan | 00909 | Puerto Rico |
| Puerto Rico AIDS Clinical Trials Unit CRS /ID# 213761 | San Juan | 00935 | Puerto Rico |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000719868 | budigalimab |
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