Clinical trial NCT06032546: A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion or Subcutaneous (SC) Injection of Budigalimab and/or ABBV-382
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Budigalimab and/or ABBV-382 in People Living With HIV on Stable Antiretroviral Therapy Undergoing Analytical Treatment Interruption
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Human Immuno-deficiency Virus (HIV) Disease
Keywords: Human immuno-deficiency virus (HIV) Disease
Budigalimab
ABBV-382
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency Syndrome (AIDS). HIV disease is considered to be a chronic disease requiring lifelong therapy. The purpose of this study is to assess change in disease activity, adverse events, tolerability, and how the drug moves through the body.

Budigalimab and ABBV-382 are investigational drugs being developed for the treatment of HIV disease. In Part 1, participants are placed in 1 of 5 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 7 chance that participants will be assigned to placebo (A placebo is not a drug and it is not expected to have any chemical effects on your body and it is not designed to treat any disease or illness). In Part 2, eligible participants will be placed in an open-label arm to receive Budigalimab. Approximately 160 adult participants living with HIV disease on stable antiretroviral therapy (ART) willing to undergo Analytical Treatment Interruption (ATI) will be enrolled at approximately 90 sites worldwide.

In Part 1, participants will receive 4 doses of intravenous (IV) budigalimab or placebo combined with 3 doses of IV ABBV-382 or placebo for an 8 week dosing period. In Part 2, participants will receive 4 doses of open-label subcutaneous (SC) Budigalimab for a 6 week dosing period. Participants need to be stable on antiretroviral therapy to participate in the study. If participant qualifies to the study, on the day they receive the first injection, participants will be asked to stop antiretroviral medications (also referred to as analytical treatment interruption or ATI) for 112 weeks or until meeting specific criteria to restart antiretroviral medications. Participants will undergo a closely monitored ART interruption. Protocol-defined ART restart criteria includes participant's request. Participants will be followed for up to approximately 112 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. There will be an option for virtual or home health visits for some of the follow-up visits. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

* A condition of general good health in the opinion of the investigator, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
* Must be on antiretroviral therapy (ART) for at least 12 months prior to screening and on a stable ART regimen for at least 8 weeks prior to screening (current ART regimen cannot include an Non-nucleoside reverse transcriptase inhibitor \[NNRTI\] or long-acting ART).
* Negative human immuno-deficiency virus (HIV)-2 antibody (Ab)
* Cluster of differentiation 4 (CD4+) T cell count \>= 500 cells/μL at screening and no known evidence of CD4+ T cell count \< 500 cells/μL in the last 12 months prior to screening
* Participant must have plasma HIV-1 ribonucleic acid (RNA) below the lower limit of quantitation (LLOQ) at screening and for at least 12 months prior to screening

Exclusion Criteria:

* Prior exposure to long acting antiretrovirals within 24 weeks or within a period defined by 5 half-lives, whichever is longer, prior to randomization and prior to the first dose of study drug.
* History of CD4+ T cell nadir of \<= 200 cells/μL during chronic HIV infection.
* History of medical disorders (other than HIV-1 infection) that, in the opinion of the investigator, might expose the participant to undue risk of harm, confound study outcomes or prevent the participant from completing the study.

Primary outcomes:
measure: Percentage of Participants with Viral Control Without Antiretroviral Therapy (ART) Restart
timeFrame: Week 24
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately Week 112
Secondary outcomes:
measure: Median Peak Viral Load (At Rebound) Prior to Re-Starting ART
timeFrame: Up to 112 weeks
measure: Median Time to First Rebound to >= 1000 Copies/mL During ART Interruption
timeFrame: Up to 112 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, 1917 Research Clinic /ID# 257549
state: Alabama
city: Bakersfield
country: United States
facility: Franco Felizarta, Md /Id# 256927
state: California
city: Beverly Hills
country: United States
facility: AHF Research Center /ID# 257025
state: California
city: Long Beach
country: United States
facility: Long Beach Education and Research Consultants /ID# 257552
state: California
city: Los Angeles
country: United States
facility: AHF Healthcare Center- Hollywood /ID# 257026
state: California
city: Los Angeles
country: United States
facility: Los Angeles LGBT Center /ID# 258407
state: California
city: Los Angeles
country: United States
facility: Ruane Clinical Research Group /ID# 256932
state: California
city: Palm Springs
country: United States
facility: Palmtree Clinical Research Inc. /Id# 258409
state: California
city: San Francisco
country: United States
facility: Optimus Medical /ID# 257182
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research /ID# 256928
state: California
city: Washington
country: United States
facility: Washington Health Institute /ID# 259336
state: District of Columbia
city: DeLand
country: United States
facility: Midland Florida Clinical Research Center /ID# 257101
state: Florida
city: Fort Lauderdale
country: United States
facility: AIDS Healthcare Foundation (AHF) - Healthcare Center - Northpoint /ID# 256934
state: Florida
city: Fort Pierce
country: United States
facility: Midway Immunology and Research Center /ID# 256930
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC /ID# 259335
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center /ID# 256931
state: Florida
city: Orlando
country: United States
facility: Bliss Health /ID# 257827
state: Florida
city: Tampa
country: United States
facility: BayCare Medical Group, Inc. /ID# 256953
state: Florida
city: Vero Beach
country: United States
facility: The Pierone Research Institute /ID# 257022
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute /ID# 256929
state: Florida
city: Atlanta
country: United States
facility: Emory Midtown Infectious Disease Clinic /ID# 258410
state: Georgia
city: Decatur
country: United States
facility: Metro Infectious Disease Consultants, P.L.L.C /ID# 256955
state: Georgia
city: Chicago
country: United States
facility: Howard Brown Health Center /ID# 257485
state: Illinois
city: Springfield
country: United States
facility: Claudia T. Martorell MD LLC dba The Research Institute /ID# 259155
state: Massachusetts
city: Kansas City
country: United States
facility: KC CARE Health Center - Midtown South /ID# 257178
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Research Center /ID# 257619
state: Nevada
city: Camden
country: United States
facility: Cooper University Health Care - Camden /ID# 258133
state: New Jersey
city: Newark
country: United States
facility: Saint Michael's Medical Center /ID# 258802
state: New Jersey
city: Somers Point
country: United States
facility: South Jersey Infectious Disease /ID# 257840
state: New Jersey
city: Albuquerque
country: United States
facility: Unmhsc /Id# 257533
state: New Mexico
city: Bronx
country: United States
facility: Jacobi Medical Center /ID# 257849
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center /ID# 257792
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University /ID# 257847
state: New York
city: Greenville
country: United States
facility: East Carolina University - Brody School of Medicine /ID# 257544
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Medical Center /ID# 257542
state: North Carolina
city: Austin
country: United States
facility: Central Texas Clinical Research /ID# 256920
state: Texas
city: Dallas
country: United States
facility: Prism Health North Texas - Oak Cliff Health Center /ID# 256933
state: Texas
city: Dallas
country: United States
facility: North Texas Infectious Diseases Consultants, P.A /ID# 257592
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center /ID# 257551
state: Texas
city: Fort Worth
country: United States
facility: Texas Center for Infectious Disease Associates /ID# 257183
state: Texas
city: Houston
country: United States
facility: The Crofoot Research Center, Inc /ID# 256921
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research /ID# 257093
state: Texas
city: Milwaukee
country: United States
facility: Wisconsin Medical Center /ID# 257498
state: Wisconsin
city: Anderlecht
country: Belgium
facility: Universite Libre de Bruxelles - Hopital Erasme /ID# 257433
state: Bruxelles-Capitale
city: Bruxelles
country: Belgium
facility: CHU Saint Pierre /ID# 257447
state: Bruxelles-Capitale
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires UCL Saint-Luc /ID# 257444
state: Bruxelles-Capitale
city: Gent
country: Belgium
facility: UZ Gent /ID# 257446
state: Oost-Vlaanderen
city: São Paulo
country: Brazil
facility: Ricardo Diaz Scientific Solution /ID# 257335
state: Sao Paulo
city: Vancouver
country: Canada
facility: Spectrum Health Vancouver /ID# 260791
state: British Columbia
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute /ID# 256993
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital /ID# 256994
state: Ontario
city: Montreal
country: Canada
facility: McGill Univ Clinical Research /ID# 256992
state: Quebec
city: Québec
country: Canada
facility: CHU de Quebec-Université Laval hôpital CHUL /ID# 261611
state: Quebec
city: Regina
country: Canada
facility: Regina General Hospital - Infectious Disease Clinic /ID# 260243
state: Saskatchewan
city: Paris
country: France
facility: AP-HP - Hopital Saint-Antoine /ID# 258090
city: Paris
country: France
facility: AP-HP - Hopital Tenon /ID# 258091
city: Frankfurt am Main
country: Germany
facility: Infektiologikum /ID# 257112
state: Hessen
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn /ID# 257113
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: zibp-Zentrum fuer Infektiologie /ID# 257110
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele /ID# 259820
state: Milano
city: Milan
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 257410
state: Milano
city: Naples
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II /ID# 257412
state: Napoli
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena /ID# 257411
city: Nagoya-shi
country: Japan
facility: NHO Nagoya Medical Center /ID# 261433
state: Aichi
city: Osaka-shi
country: Japan
facility: National Hospital Organization Osaka National Hospital /ID# 261520
state: Osaka
city: Tokyo
country: Japan
facility: IMSUT Hospital, The Institute of Medical Science, The University of Tokyo /ID# 265344
city: Bydgoszcz
country: Poland
facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 259184
state: Kujawsko-pomorskie
city: Gdańsk
country: Poland
facility: Punkt Zdrowia /ID# 257950
state: Pomorskie
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico /ID# 256956
city: San Juan
country: Puerto Rico
facility: HOPE Clinical Research /ID# 257487
city: Johannesburg
country: South Africa
facility: Wits RHI Research Centre /ID# 257354
state: Gauteng
city: Johannesburg
country: South Africa
facility: Perinatal HIV Research Unit (PHRU) /ID# 257350
state: Gauteng
city: Johannesburg
country: South Africa
facility: Clinical HIV Research Unit (CHRU) /ID# 257358
state: Gauteng
city: Johannesburg
country: South Africa
facility: Ezintsha Research Centre /ID# 257391
state: Gauteng
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol /ID# 257268
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona /ID# 257269
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal /ID# 257266
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 257170
city: London
country: United Kingdom
facility: Royal Free Hospital /ID# 257453
state: Greater London
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust /ID# 257761
state: Greater London
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: