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 of Budigalimab and/or ABBV-382
- Conditions
- Human Immuno-deficiency Virus (HIV) Disease
- Interventions
- Registration Number
- NCT06032546
- Lead Sponsor
- AbbVie
- 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. 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). Approximately 140 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.
Participants will receive 4 doses of IV budigalimab or placebo combined with 3 doses of IV ABBV-382 or placebo for an 8 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 52 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 52 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 163
- 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 current ART regimen for at least 8 weeks prior to screening (current ART regimen cannot include an Non-nucleoside reverse transcriptase inhibitor [NNRTI]).
- Negative human immuno-deficiency virus (HIV)-2 antibody (Ab)
- 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
- 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 cluster of differentiation 4 (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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Placebo Placebo for Budigalimab Participants will receive budigalimab placebo on Day 1, and Weeks 2, 4, and 6 in combination with ABBV-382 matching placebo on Day 1 and Weeks 4 and 8. Arm A: Placebo Placebo for ABBV-382 Participants will receive budigalimab placebo on Day 1, and Weeks 2, 4, and 6 in combination with ABBV-382 matching placebo on Day 1 and Weeks 4 and 8. Arm B: Budigalimab Dose A Budigalimab Participants will receive budigalimab Dose A on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 matching placebo Day 1 and Weeks 4 and 8. Arm B: Budigalimab Dose A Placebo for ABBV-382 Participants will receive budigalimab Dose A on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 matching placebo Day 1 and Weeks 4 and 8. Arm C: ABBV-382 Dose A Placebo for Budigalimab Participants will receive budigalimab placebo on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose A on Day 1 and Weeks 4 and 8. Arm C: ABBV-382 Dose A ABBV-382 Participants will receive budigalimab placebo on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose A on Day 1 and Weeks 4 and 8. Arm D: Budigalimab Dose A + ABBV-382 Dose B Budigalimab Participants will receive budigalimab Dose A on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose B on Day 1 and Weeks 4 and 8. Arm D: Budigalimab Dose A + ABBV-382 Dose B ABBV-382 Participants will receive budigalimab Dose A on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose B on Day 1 and Weeks 4 and 8. Arm E: Budigalimab Dose A + ABBV-382 Dose A Budigalimab Participants will receive budigalimab Dose A on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose A on Day 1 and Weeks 4 and 8. Arm E: Budigalimab Dose A + ABBV-382 Dose A ABBV-382 Participants will receive budigalimab Dose A on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose A on Day 1 and Weeks 4 and 8. Arm F: Budigalimab Dose B Budigalimab Participants will receive open-label budigalimab Dose B on Day 1 and Weeks 2, 4, and 6 (Note, no ABBV-382 or placebo will be administered).
- Primary Outcome Measures
Name Time Method Percentage of Participants with Viral Control Without Antiretroviral Therapy (ART) Restart Week 24 Percentage of participants who achieve viral control (viral load \< 1000 copies/mL) without ART restart at Week 24.
Number of Participants with Adverse Events (AEs) Up to approximately Week 112 An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
- Secondary Outcome Measures
Name Time Method Median Peak Viral Load (At Rebound) Prior to Re-Starting ART Up to 112 weeks The median peak viral load (at rebound) before re-starting ART.
Median Time to First Rebound to >= 1000 Copies/mL During ART Interruption Up to 112 weeks The median time to rebound to \>= 1000 copies/mL during ART interruption.
Trial Locations
- Locations (80)
University of Alabama at Birmingham, 1917 Research Clinic /ID# 257549
🇺🇸Birmingham, Alabama, United States
Franco Felizarta, Md /Id# 256927
🇺🇸Bakersfield, California, United States
AHF Research Center /ID# 257025
🇺🇸Beverly Hills, California, United States
Long Beach Education and Research Consultants /ID# 257552
🇺🇸Long Beach, California, United States
AHF Healthcare Center- Hollywood /ID# 257026
🇺🇸Los Angeles, California, United States
Los Angeles LGBT Center /ID# 258407
🇺🇸Los Angeles, California, United States
Ruane Clinical Research Group /ID# 256932
🇺🇸Los Angeles, California, United States
Palmtree Clinical Research Inc. /Id# 258409
🇺🇸Palm Springs, California, United States
Optimus Medical /ID# 257182
🇺🇸San Francisco, California, United States
Quest Clinical Research /ID# 256928
🇺🇸San Francisco, California, United States
Washington Health Institute /ID# 259336
🇺🇸Washington, District of Columbia, United States
Midland Florida Clinical Research Center /ID# 257101
🇺🇸DeLand, Florida, United States
AIDS Healthcare Foundation (AHF) - Healthcare Center - Northpoint /ID# 256934
🇺🇸Fort Lauderdale, Florida, United States
Midway Immunology and Research Center /ID# 256930
🇺🇸Fort Pierce, Florida, United States
Advanced Pharma CR, LLC /ID# 259335
🇺🇸Miami, Florida, United States
Orlando Immunology Center /ID# 256931
🇺🇸Orlando, Florida, United States
Bliss Health /ID# 257827
🇺🇸Orlando, Florida, United States
BayCare Medical Group, Inc. /ID# 256953
🇺🇸Tampa, Florida, United States
The Pierone Research Institute /ID# 257022
🇺🇸Vero Beach, Florida, United States
Triple O Research Institute /ID# 256929
🇺🇸West Palm Beach, Florida, United States
Emory Midtown Infectious Disease Clinic /ID# 258410
🇺🇸Atlanta, Georgia, United States
Metro Infectious Disease Consultants, P.L.L.C /ID# 256955
🇺🇸Decatur, Georgia, United States
Howard Brown Health Center /ID# 257485
🇺🇸Chicago, Illinois, United States
Claudia T. Martorell MD LLC dba The Research Institute /ID# 259155
🇺🇸Springfield, Massachusetts, United States
KC CARE Health Center - Midtown South /ID# 257178
🇺🇸Kansas City, Missouri, United States
Las Vegas Research Center /ID# 257619
🇺🇸Las Vegas, Nevada, United States
Cooper University Health Care - Camden /ID# 258133
🇺🇸Camden, New Jersey, United States
Saint Michael's Medical Center /ID# 258802
🇺🇸Newark, New Jersey, United States
South Jersey Infectious Disease /ID# 257840
🇺🇸Somers Point, New Jersey, United States
Unmhsc /Id# 257533
🇺🇸Albuquerque, New Mexico, United States
Jacobi Medical Center /ID# 257849
🇺🇸Bronx, New York, United States
Montefiore Medical Center /ID# 257792
🇺🇸Bronx, New York, United States
SUNY Upstate Medical University /ID# 257847
🇺🇸Syracuse, New York, United States
East Carolina University - Brody School of Medicine /ID# 257544
🇺🇸Greenville, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 257542
🇺🇸Winston-Salem, North Carolina, United States
Central Texas Clinical Research /ID# 256920
🇺🇸Austin, Texas, United States
Prism Health North Texas - Oak Cliff Health Center /ID# 256933
🇺🇸Dallas, Texas, United States
North Texas Infectious Diseases Consultants, P.A /ID# 257592
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center /ID# 257551
🇺🇸Dallas, Texas, United States
Texas Center for Infectious Disease Associates /ID# 257183
🇺🇸Fort Worth, Texas, United States
The Crofoot Research Center, Inc /ID# 256921
🇺🇸Houston, Texas, United States
DCOL Center for Clinical Research /ID# 257093
🇺🇸Longview, Texas, United States
Wisconsin Medical Center /ID# 257498
🇺🇸Milwaukee, Wisconsin, United States
Universite Libre de Bruxelles - Hopital Erasme /ID# 257433
🇧🇪Anderlecht, Bruxelles-Capitale, Belgium
CHU Saint Pierre /ID# 257447
🇧🇪Bruxelles, Bruxelles-Capitale, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 257444
🇧🇪Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium
UZ Gent /ID# 257446
🇧🇪Gent, Oost-Vlaanderen, Belgium
Ricardo Diaz Scientific Solution /ID# 257335
🇧🇷São Paulo, Sao Paulo, Brazil
Spectrum Health Vancouver /ID# 260791
🇨🇦Vancouver, British Columbia, Canada
Ottawa Hospital Research Institute /ID# 256993
🇨🇦Ottawa, Ontario, Canada
Toronto General Hospital /ID# 256994
🇨🇦Toronto, Ontario, Canada
McGill Univ Clinical Research /ID# 256992
🇨🇦Montreal, Quebec, Canada
CHU de Quebec-Université Laval hôpital CHUL /ID# 261611
🇨🇦Québec, Quebec, Canada
Regina General Hospital - Infectious Disease Clinic /ID# 260243
🇨🇦Regina, Saskatchewan, Canada
AP-HP - Hopital Saint-Antoine /ID# 258090
🇫🇷Paris, France
AP-HP - Hopital Tenon /ID# 258091
🇫🇷Paris, France
Infektiologikum /ID# 257112
🇩🇪Frankfurt am Main, Hessen, Germany
Universitaetsklinikum Bonn /ID# 257113
🇩🇪Bonn, Nordrhein-Westfalen, Germany
zibp-Zentrum fuer Infektiologie /ID# 257110
🇩🇪Berlin, Germany
IRCCS Ospedale San Raffaele /ID# 259820
🇮🇹Milan, Milano, Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 257410
🇮🇹Milan, Milano, Italy
Azienda Ospedaliera Universitaria Federico II /ID# 257412
🇮🇹Naples, Napoli, Italy
Azienda Ospedaliero-Universitaria di Modena /ID# 257411
🇮🇹Modena, Italy
NHO Nagoya Medical Center /ID# 261433
🇯🇵Nagoya-shi, Aichi, Japan
National Hospital Organization Osaka National Hospital /ID# 261520
🇯🇵Osaka-shi, Osaka, Japan
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo /ID# 265344
🇯🇵Tokyo, Japan
Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 259184
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Punkt Zdrowia /ID# 257950
🇵🇱Gdańsk, Pomorskie, Poland
Clinical Research Puerto Rico /ID# 256956
🇵🇷San Juan, Puerto Rico
HOPE Clinical Research /ID# 257487
🇵🇷San Juan, Puerto Rico
Wits RHI Research Centre /ID# 257354
🇿🇦Johannesburg, Gauteng, South Africa
Perinatal HIV Research Unit (PHRU) /ID# 257350
🇿🇦Johannesburg, Gauteng, South Africa
Clinical HIV Research Unit (CHRU) /ID# 257358
🇿🇦Johannesburg, Gauteng, South Africa
Ezintsha Research Centre /ID# 257391
🇿🇦Johannesburg, Gauteng, South Africa
Hospital Universitario Germans Trias i Pujol /ID# 257268
🇪🇸Badalona, Barcelona, Spain
Hospital Clinic de Barcelona /ID# 257269
🇪🇸Barcelona, Spain
Hospital Universitario Ramon y Cajal /ID# 257266
🇪🇸Madrid, Spain
Hospital Universitario La Paz /ID# 257170
🇪🇸Madrid, Spain
Royal Free Hospital /ID# 257453
🇬🇧London, Greater London, United Kingdom
Guys and St Thomas NHS Foundation Trust /ID# 257761
🇬🇧London, Greater London, United Kingdom