Eine Studie zur Bewertung der Veränderung der Krankheitsaktivität, unerwünschter Ereignisse und der Art und Weise, wie sich das Medikament durch den Körper bewegt, bei erwachsenen Teilnehmern, die mit dem humanen Immundefizienzvirus (HIV) leben und eine intravenöse (IV) Infusion von Budigalimab und/oder ABBV-382 erhalten
Eine multizentrische, randomisierte, doppelblinde, placebokontrollierte Phase-2-Studie zur Bewertung der Wirksamkeit, Sicherheit, Verträglichkeit und Pharmakokinetik von Budigalimab und/oder ABBV-382 bei Menschen mit HIV unter stabiler antiretroviraler Therapie, die sich einer analytischen Behandlungsunterbrechung unterziehen
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.
Studienübersicht
Status
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Brussels Capital
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Anderlecht, Brussels Capital, Belgien, 1070
- Universite Libre de Bruxelles - Hopital Erasme /ID# 257433
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Brussels, Brussels Capital, Belgien, 1000
- CHU Saint Pierre /ID# 257447
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Brussels, Brussels Capital, Belgien, 1200
- Cliniques Universitaires UCL Saint-Luc /ID# 257444
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Belgien, 9000
- UZ Gent /ID# 257446
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São Paulo
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São Paulo, São Paulo, Brasilien, 04037-030
- Ricardo Diaz Scientific Solution /ID# 257335
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Berlin, Deutschland, 10439
- zibp-Zentrum fuer Infektiologie /ID# 257110
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Hesse
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Frankfurt am Main, Hesse, Deutschland, 60596
- Infektiologikum /ID# 257112
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Deutschland, 53127
- Universitaetsklinikum Bonn /ID# 257113
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Paris, Frankreich, 75012
- AP-HP - Hopital Saint-Antoine /ID# 258090
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Paris, Frankreich, 75020
- AP-HP - Hopital Tenon /ID# 258091
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Modena, Italien, 41124
- Azienda Ospedaliero-Universitaria di Modena /ID# 257411
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Milano
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Milan, Milano, Italien, 20132
- IRCCS Ospedale San Raffaele /ID# 259820
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Milan, Milano, Italien, 20162
- ASST Grande Ospedale Metropolitano Niguarda /ID# 257410
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Napoli
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Naples, Napoli, Italien, 80131
- Azienda Ospedaliera Universitaria Federico II - Naples /ID# 257412
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Tokyo, Japan, 108-8639
- IMSUT Hospital, The Institute of Medical Science, The University of Tokyo /ID# 265344
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 460-0001
- NHO Nagoya Medical Center /ID# 261433
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Osaka
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Osaka, Osaka, Japan, 540-0006
- National Hospital Organization Osaka National Hospital /ID# 261520
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British Columbia
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Vancouver, British Columbia, Kanada, V6Z 2T1
- Spectrum Health Vancouver /ID# 260791
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Ontario
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Ottawa, Ontario, Kanada, K1H 8L6
- Ottawa Hospital Research Institute /ID# 256993
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Toronto, Ontario, Kanada, M5G 2C4
- Duplicate_Toronto General Hospital /ID# 256994
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Quebec
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Montreal, Quebec, Kanada, H4A 3J1
- McGill University Health Centre - Glen Site. /ID# 256992
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Québec, Quebec, Kanada, G1V 4G2
- CHU de Quebec-Université Laval hôpital CHUL /ID# 261611
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Saskatchewan
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Regina, Saskatchewan, Kanada, S4P 0W5
- Regina General Hospital - Infectious Disease Clinic /ID# 260243
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Kuyavian-Pomeranian Voivodeship
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polen, 85-030
- Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 259184
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Polen, 80-405
- Punkt Zdrowia /ID# 257950
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San Juan, Puerto Rico, 00909-1711
- Clinical Research Puerto Rico /ID# 256956
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San Juan, Puerto Rico, 00909
- HOPE Clinical Research /ID# 257487
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Barcelona, Spanien, 08036
- Hospital Clinic de Barcelona /ID# 257269
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Madrid, Spanien, 28034
- Hospital Universitario Ramon y Cajal /ID# 257266
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Madrid, Spanien, 28046
- Hospital Universitario La Paz /ID# 257170
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Barcelona
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Badalona, Barcelona, Spanien, 08916
- Hospital Universitario Germans Trias i Pujol /ID# 257268
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Gauteng
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Johannesburg, Gauteng, Südafrika, 2001
- Wits RHI Research Centre /ID# 257354
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Johannesburg, Gauteng, Südafrika, 2013
- Perinatal HIV Research Unit (PHRU) /ID# 257350
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Johannesburg, Gauteng, Südafrika, 2092
- Clinical HIV Research Unit (CHRU) /ID# 257358
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Johannesburg, Gauteng, Südafrika, 2193
- Ezintsha Research Centre /ID# 257391
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35222-2309
- University of Alabama at Birmingham, 1917 Research Clinic /ID# 257549
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California
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Bakersfield, California, Vereinigte Staaten, 93301
- Franco Felizarta, Md /Id# 256927
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Beverly Hills, California, Vereinigte Staaten, 90211
- AHF Research Center /ID# 257025
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Long Beach, California, Vereinigte Staaten, 90813-3267
- Long Beach Education and Research Consultants /ID# 257552
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Los Angeles, California, Vereinigte Staaten, 90027
- AHF Healthcare Center- Hollywood /ID# 257026
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Los Angeles, California, Vereinigte Staaten, 90028-6213
- Los Angeles LGBT Center /ID# 258407
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Los Angeles, California, Vereinigte Staaten, 90036
- Ruane Clinical Research Group /ID# 256932
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Palm Springs, California, Vereinigte Staaten, 92262
- Palmtree Clinical Research Inc. /Id# 258409
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San Francisco, California, Vereinigte Staaten, 94102
- Optimus Medical /ID# 257182
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San Francisco, California, Vereinigte Staaten, 94115-3037
- Quest Clinical Research /ID# 256928
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District of Columbia
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Washington D.C., District of Columbia, Vereinigte Staaten, 20017
- Washington Health Institute /ID# 259336
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Florida
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DeLand, Florida, Vereinigte Staaten, 32720-0920
- Midland Florida Clinical Research Center /ID# 257101
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Fort Lauderdale, Florida, Vereinigte Staaten, 33308
- Ahf Healthcare Center - Northpoint /ID# 256934
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Ft. Pierce, Florida, Vereinigte Staaten, 34982
- Midway Immunology and Research Center /ID# 256930
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Miami, Florida, Vereinigte Staaten, 33147
- Advanced Pharma CR, LLC /ID# 259335
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Orlando, Florida, Vereinigte Staaten, 32803
- Orlando Immunology Center /ID# 256931
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Orlando, Florida, Vereinigte Staaten, 32806-3300
- Bliss Health /ID# 257827
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Tampa, Florida, Vereinigte Staaten, 33614
- Baycare Medical Group - Tampa /ID# 256953
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Vero Beach, Florida, Vereinigte Staaten, 32960-6541
- The Pierone Research Institute /ID# 257022
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West Palm Beach, Florida, Vereinigte Staaten, 33407
- Triple O Research Institute /ID# 256929
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30308
- Winship At Emory University Hospital Midtown /ID# 258410
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Decatur, Georgia, Vereinigte Staaten, 30033
- Metro Infectious Disease Consultants /ID# 256955
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60613-2010
- Howard Brown Health Center /ID# 257485
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Massachusetts
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Springfield, Massachusetts, Vereinigte Staaten, 01105-1406
- Claudia T. Martorell MD LLC dba The Research Institute /ID# 259155
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Missouri
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Kansas City, Missouri, Vereinigte Staaten, 64111
- KC CARE Health Center - Midtown South /ID# 257178
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Nevada
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Las Vegas, Nevada, Vereinigte Staaten, 89106
- Las Vegas Research Center /ID# 257619
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New Jersey
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Camden, New Jersey, Vereinigte Staaten, 08103
- Cooper University Health Care - Camden /ID# 258133
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Newark, New Jersey, Vereinigte Staaten, 07102
- Saint Michael's Medical Center /ID# 258802
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Somers Point, New Jersey, Vereinigte Staaten, 08244
- South Jersey Infectious Disease /ID# 257840
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New Mexico
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Albuquerque, New Mexico, Vereinigte Staaten, 87106
- The University of New Mexico /ID# 257533
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New York
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Syracuse, New York, Vereinigte Staaten, 13215
- Suny Upstate University Hospital Community Campus /ID# 257847
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The Bronx, New York, Vereinigte Staaten, 10461
- Jacobi Medical Center /ID# 257849
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The Bronx, New York, Vereinigte Staaten, 10467
- Montefiore Medical Center /ID# 257792
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North Carolina
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Greenville, North Carolina, Vereinigte Staaten, 27834
- East Carolina University - Brody School of Medicine /ID# 257544
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Winston-Salem, North Carolina, Vereinigte Staaten, 27157
- Atrium Health Wake Forest Baptist Medical Center /ID# 257542
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Texas
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Austin, Texas, Vereinigte Staaten, 78705-3326
- Central Texas Clinical Research /ID# 256920
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Dallas, Texas, Vereinigte Staaten, 75208-4599
- Prism Health North Texas - Oak Cliff Health Center /ID# 256933
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Dallas, Texas, Vereinigte Staaten, 75246
- North Texas Infectious Diseases Consultants, P.A /ID# 257592
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Dallas, Texas, Vereinigte Staaten, 75390-7208
- University of Texas Southwestern Medical Center /ID# 257551
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Fort Worth, Texas, Vereinigte Staaten, 76104
- Texas Center for Infectious Disease Associates /ID# 257183
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Houston, Texas, Vereinigte Staaten, 77098-3900
- The Crofoot Research Center, Inc /ID# 256921
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Longview, Texas, Vereinigte Staaten, 75605
- DCOL Center for Clinical Research /ID# 257093
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Wisconsin
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Milwaukee, Wisconsin, Vereinigte Staaten, 53226
- Wisconsin Medical Center /ID# 257498
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Greater London
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London, Greater London, Vereinigtes Königreich, NW3 2QG
- Royal Free Hospital /ID# 257453
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London, Greater London, Vereinigtes Königreich, SE1 9RT
- Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 257761
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Placebo-Komparator: Arm A: Placebo
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. |
IV Infusion IV Infusion |
|
Experimental: Arm B: Budigalimab Dose A
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. |
IV Infusion Intravenous (IV) Infusion
Andere Namen:
Subcutaneous (SC) Injection
Andere Namen:
|
|
Experimental: Arm C: ABBV-382 Dose A
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. |
IV Infusion IV Infusion |
|
Experimental: Arm D: Budigalimab Dose A + ABBV-382 Dose B
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. |
Intravenous (IV) Infusion
Andere Namen:
Subcutaneous (SC) Injection
Andere Namen:
IV Infusion |
|
Experimental: Arm E: Budigalimab Dose A + ABBV-382 Dose A
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. |
Intravenous (IV) Infusion
Andere Namen:
Subcutaneous (SC) Injection
Andere Namen:
IV Infusion |
|
Experimental: Arm F: Budigalimab Dose B
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). |
Intravenous (IV) Infusion
Andere Namen:
Subcutaneous (SC) Injection
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Percentage of Participants With Viral Control Without Antiretroviral Therapy (ART) Restart
Zeitfenster: Week 24
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Percentage of participants who achieve viral control (viral load < 1000 copies/mL) without ART restart at Week 24. |
Week 24
|
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Number of Participants With Adverse Events (AEs)
Zeitfenster: Up to approximately Week 112
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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. |
Up to approximately Week 112
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Median Peak Log10 Viral Load (At Rebound) Prior to Re-Starting ART
Zeitfenster: Up to 112 weeks
|
The median peak log10 viral load (at rebound) before re-starting ART. |
Up to 112 weeks
|
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Median Time to First Rebound to ≥ 1000 Copies/mL During ART Interruption
Zeitfenster: Up to 112 weeks
|
The median time to first rebound to ≥ 1000 copies/mL during ART interruption. |
Up to 112 weeks
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: ABBVIE INC., AbbVie
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- M19-965
- 2023-505900-53-00 (Andere Kennung: EU CT)
- 2023 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
IPD-Sharing-Zeitrahmen
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD-Sharing-Zugriffskriterien
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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