Phase
Condition
Aids And Aids Related Infections
Hiv/aids
Hiv Infections
Treatment
Placebo for ABBV-382
Placebo for Budigalimab
Budigalimab
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
A condition of general good health in the opinion of the investigator, based uponthe results of a medical history, physical examination, vital signs, laboratoryprofile, and a 12-lead electrocardiogram (ECG).
Must be on antiretroviral therapy (ART) for at least 12 months prior to screeningand on a stable ART regimen for at least 8 weeks prior to screening (current ARTregimen cannot include an Non-nucleoside reverse transcriptase inhibitor [NNRTI] orlong-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 noknown evidence of CD4+ T cell count < 500 cells/μL in the last 12 months prior toscreening
Participant must have plasma HIV-1 ribonucleic acid (RNA) below the lower limit ofquantitation (LLOQ) at screening and for at least 12 months prior to screening
Exclusion
Exclusion Criteria:
Prior exposure to long acting antiretrovirals within 24 weeks or within a perioddefined by 5 half-lives, whichever is longer, prior to randomization and prior tothe 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 ofthe investigator, might expose the participant to undue risk of harm, confound studyoutcomes or prevent the participant from completing the study.
Study Design
Connect with a study center
Universite Libre de Bruxelles - Hopital Erasme /ID# 257433
Anderlecht 2803201, Brussels Capital 2800867 1070
BelgiumSite Not Available
CHU Saint Pierre /ID# 257447
Brussels 2800866, Brussels Capital 2800867 1000
BelgiumSite Not Available
Cliniques Universitaires UCL Saint-Luc /ID# 257444
Brussels 2800866, Brussels Capital 2800867 1200
BelgiumSite Not Available
Universite Libre de Bruxelles - Hopital Erasme /ID# 257433
Anderlecht, Bruxelles-Capitale 1070
BelgiumSite Not Available
CHU Saint Pierre /ID# 257447
Bruxelles, Bruxelles-Capitale 1000
BelgiumSite Not Available
Cliniques Universitaires UCL Saint-Luc /ID# 257444
Bruxelles, Bruxelles-Capitale 1200
BelgiumSite Not Available
Cliniques Universitaires UCL Saint-Luc /ID# 257444
Woluwe-Saint-Lambert, Bruxelles-Capitale 1200
BelgiumSite Not Available
UZ Gent /ID# 257446
Gent, Oost-Vlaanderen 9000
BelgiumSite Not Available
UZ Gent /ID# 257446
Ghent 2797656, Oost-Vlaanderen 9000
BelgiumSite Not Available
Ricardo Diaz Scientific Solution /ID# 257335
São Paulo, Sao Paulo 04037-030
BrazilSite Not Available
Ricardo Diaz Scientific Solution /ID# 257335
São Paulo 3448439, São Paulo 3448433 04037-030
BrazilSite Not Available
Spectrum Health Vancouver /ID# 260791
Vancouver, British Columbia V6Z 2T1
CanadaSite Not Available
Spectrum Health Vancouver /ID# 260791
Vancouver 6173331, British Columbia 5909050 V6Z 2T1
CanadaSite Not Available
Ottawa Hospital Research Institute /ID# 256993
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Toronto General Hospital /ID# 256994
Toronto, Ontario M5G 2C4
CanadaSite Not Available
Ottawa Hospital Research Institute /ID# 256993
Ottawa 6094817, Ontario 6093943 K1H 8L6
CanadaSite Not Available
Toronto General Hospital /ID# 256994
Toronto 6167865, Ontario 6093943 M5G 2C4
CanadaSite Not Available
McGill Univ Clinical Research /ID# 256992
Montreal, Quebec H2X 2P4
CanadaSite Not Available
McGill University Health Centre - Glen Site /ID# 256992
Montreal, Quebec H4A 3J1
CanadaSite Not Available
CHU de Quebec-Université Laval hôpital CHUL /ID# 261611
Québec, Quebec G1V 4G2
CanadaSite Not Available
McGill University Health Centre - Glen Site /ID# 256992
Montreal 6077243, Quebec 6115047 H4A 3J1
CanadaSite Not Available
CHU de Quebec-Université Laval hôpital CHUL /ID# 261611
Québec 6325494, Quebec 6115047 G1V 4G2
CanadaSite Not Available
Regina General Hospital - Infectious Disease Clinic /ID# 260243
Regina, Saskatchewan S4P 0W5
CanadaSite Not Available
Regina General Hospital - Infectious Disease Clinic /ID# 260243
Regina 6119109, Saskatchewan 6141242 S4P 0W5
CanadaSite Not Available
AP-HP - Hopital Saint-Antoine /ID# 258090
Paris, 75012
FranceSite Not Available
AP-HP - Hopital Tenon /ID# 258091
Paris, 75020
FranceSite Not Available
AP-HP - Hopital Saint-Antoine /ID# 258090
Paris 2988507, 75012
FranceSite Not Available
AP-HP - Hopital Tenon /ID# 258091
Paris 2988507, 75020
FranceSite Not Available
Infektiologikum /ID# 257112
Frankfurt am Main 2925533, Hesse 2905330 60596
GermanySite Not Available
Infektiologikum /ID# 257112
Frankfurt am Main, Hessen 60596
GermanySite Not Available
Universitaetsklinikum Bonn /ID# 257113
Bonn, Nordrhein-Westfalen 53127
GermanySite Not Available
Universitaetsklinikum Bonn /ID# 257113
Bonn 2946447, North Rhine-Westphalia 2861876 53127
GermanySite Not Available
zibp-Zentrum fuer Infektiologie /ID# 257110
Berlin, 10439
GermanySite Not Available
zibp-Zentrum fuer Infektiologie /ID# 257110
Berlin 2950159, 10439
GermanySite Not Available
Azienda Ospedaliera Universitaria Federico II /ID# 257412
Napoli, L Aquila 80131
ItalySite Not Available
ASST Grande Ospedale Metropolitano Niguarda /ID# 257410
Milan, Milano 20162
ItalySite Not Available
IRCCS Ospedale San Raffaele /ID# 259820
Milan, Milano 20132
ItalySite Not Available
Ospedale San Raffaele IRCCS /ID# 259820
Milan, Milano 20132
ItalySite Not Available
ASST Grande Ospedale Metropolitano Niguarda /ID# 257410
Milan 3173435, Milano 20162
ItalySite Not Available
IRCCS Ospedale San Raffaele /ID# 259820
Milan 3173435, Milano 20132
ItalySite Not Available
Azienda Ospedaliera Universitaria Federico II /ID# 257412
Naples, Napoli 80131
ItalySite Not Available
Azienda Ospedaliera Universitaria Federico II /ID# 257412
Naples 3172394, Napoli 80131
ItalySite Not Available
Azienda Ospedaliero-Universitaria di Modena /ID# 257411
Modena, 41124
ItalySite Not Available
Azienda Ospedaliero-Universitaria di Modena /ID# 257411
Modena 3173331, 41124
ItalySite Not Available
NHO Nagoya Medical Center /ID# 261433
Nagoya-shi, Aichi 460-0001
JapanSite Not Available
NHO Nagoya Medical Center /ID# 261433
Nagoya 1856057, Aichi-ken 1865694 460-0001
JapanSite Not Available
National Hospital Organization Osaka National Hospital /ID# 261520
Osaka-shi, Osaka 540-0006
JapanSite Not Available
National Hospital Organization Osaka National Hospital /ID# 261520
Osaka 1853909, Osaka 1853904 540-0006
JapanSite Not Available
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo /ID# 265344
Tokyo, 108-8639
JapanSite Not Available
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo /ID# 265344
Tokyo 1850147, 108-8639
JapanSite Not Available
Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 259184
Bydgoszcz, Kujawsko-pomorskie 85-030
PolandSite Not Available
Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 259184
Bydgoszcz 3102014, Kuyavian-Pomeranian Voivodeship 3337500 85-030
PolandSite Not Available
Punkt Zdrowia /ID# 257950
Gdansk 3099434, Pomeranian Voivodeship 3337496 80-405
PolandSite Not Available
Punkt Zdrowia /ID# 257950
Gdańsk, Pomorskie 80-405
PolandSite Not Available
Clinical Research Puerto Rico /ID# 256956
San Juan, 00909-1711
Puerto RicoSite Not Available
HOPE Clinical Research /ID# 257487
San Juan, 00909
Puerto RicoSite Not Available
Clinical Research Puerto Rico /ID# 256956
San Juan 4568127, 00909-1711
Puerto RicoSite Not Available
HOPE Clinical Research /ID# 257487
San Juan 4568127, 00909
Puerto RicoSite Not Available
Clinical HIV Research Unit (CHRU) /ID# 257358
Johannesburg, Gauteng 2092
South AfricaSite Not Available
Ezintsha Research Centre /ID# 257391
Johannesburg, Gauteng 2193
South AfricaSite Not Available
Perinatal HIV Research Unit (PHRU) /ID# 257350
Johannesburg, Gauteng 2013
South AfricaSite Not Available
Wits RHI Research Centre /ID# 257354
Johannesburg, Gauteng 2001
South AfricaSite Not Available
Clinical HIV Research Unit (CHRU) /ID# 257358
Johannesburg 993800, Gauteng 1085594 2092
South AfricaSite Not Available
Ezintsha Research Centre /ID# 257391
Johannesburg 993800, Gauteng 1085594 2193
South AfricaSite Not Available
Perinatal HIV Research Unit (PHRU) /ID# 257350
Johannesburg 993800, Gauteng 1085594 2013
South AfricaSite Not Available
Wits RHI Research Centre /ID# 257354
Johannesburg 993800, Gauteng 1085594 2001
South AfricaSite Not Available
Hospital Universitario Germans Trias i Pujol /ID# 257268
Badalona, Barcelona 08916
SpainSite Not Available
Hospital Universitario Germans Trias i Pujol /ID# 257268
Badalona 3129028, Barcelona 08916
SpainSite Not Available
Hospital Clinic de Barcelona /ID# 257269
Barcelona, 08036
SpainSite Not Available
Hospital Clinic de Barcelona /ID# 257269
Barcelona 3128760, 08036
SpainSite Not Available
Hospital Universitario La Paz /ID# 257170
Madrid, 28046
SpainSite Not Available
Hospital Universitario Ramon y Cajal /ID# 257266
Madrid, 28034
SpainSite Not Available
Hospital Universitario La Paz /ID# 257170
Madrid 3117735, 28046
SpainSite Not Available
Hospital Universitario Ramon y Cajal /ID# 257266
Madrid 3117735, 28034
SpainSite Not Available
Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 257761
London, Greater London SE1 9RT
United KingdomSite Not Available
Guys and St Thomas NHS Foundation Trust /ID# 257761
London, Greater London SE1 9RT
United KingdomSite Not Available
Royal Free Hospital /ID# 257453
London, Greater London NW3 2QG
United KingdomSite Not Available
Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 257761
London 2643743, Greater London SE1 9RT
United KingdomSite Not Available
Royal Free Hospital /ID# 257453
London 2643743, Greater London NW3 2QG
United KingdomSite Not Available
University of Alabama at Birmingham, 1917 Research Clinic /ID# 257549
Birmingham, Alabama 35222-2309
United StatesSite Not Available
University of Alabama at Birmingham, 1917 Research Clinic /ID# 257549
Birmingham 4049979, Alabama 4829764 35222-2309
United StatesSite Not Available
Franco Felizarta, Md /Id# 256927
Bakersfield, California 93301
United StatesSite Not Available
AHF Research Center /ID# 257025
Beverly Hills, California 90211
United StatesSite Not Available
Long Beach Education and Research Consultants /ID# 257552
Long Beach, California 90813-3267
United StatesSite Not Available
AHF Healthcare Center- Hollywood /ID# 257026
Los Angeles, California 90027
United StatesSite Not Available
Los Angeles LGBT Center /ID# 258407
Los Angeles, California 90028-6213
United StatesSite Not Available
Ruane Clinical Research Group /ID# 256932
Los Angeles, California 90036
United StatesSite Not Available
Palmtree Clinical Research Inc. /Id# 258409
Palm Springs, California 92262
United StatesSite Not Available
Optimus Medical /ID# 257182
San Francisco, California 94102
United StatesSite Not Available
Optimus Medical Group /ID# 257182
San Francisco, California 94102-3001
United StatesActive - Recruiting
Quest Clinical Research /ID# 256928
San Francisco, California 94115-3037
United StatesSite Not Available
Franco Felizarta, Md /Id# 256927
Bakersfield 5325738, California 5332921 93301
United StatesSite Not Available
AHF Research Center /ID# 257025
Beverly Hills 5328041, California 5332921 90211
United StatesSite Not Available
Long Beach Education and Research Consultants /ID# 257552
Long Beach 5367929, California 5332921 90813-3267
United StatesSite Not Available
AHF Healthcare Center- Hollywood /ID# 257026
Los Angeles 5368361, California 5332921 90027
United StatesSite Not Available
Los Angeles LGBT Center /ID# 258407
Los Angeles 5368361, California 5332921 90028-6213
United StatesSite Not Available
Ruane Clinical Research Group /ID# 256932
Los Angeles 5368361, California 5332921 90036
United StatesSite Not Available
Palmtree Clinical Research Inc. /Id# 258409
Palm Springs 5380668, California 5332921 92262
United StatesSite Not Available
Optimus Medical /ID# 257182
San Francisco 5391959, California 5332921 94102
United StatesSite Not Available
Quest Clinical Research /ID# 256928
San Francisco 5391959, California 5332921 94115-3037
United StatesSite Not Available
Washington Health Institute /ID# 259336
Washington, District of Columbia 20017
United StatesSite Not Available
Washington Health Institute /ID# 259336
Washington D.C. 4140963, District of Columbia 4138106 20017
United StatesSite Not Available
Midland Florida Clinical Research Center /ID# 257101
DeLand, Florida 32720-0920
United StatesSite Not Available
AIDS Healthcare Foundation (AHF) - Healthcare Center - Northpoint /ID# 256934
Fort Lauderdale, Florida 33308
United StatesSite Not Available
AIDS Healthcare Foundation - Northpoint /ID# 256934
Fort Lauderdale, Florida 33308
United StatesActive - Recruiting
Midway Immunology and Research Center /ID# 256930
Fort Pierce, Florida 34982
United StatesSite Not Available
Advanced Pharma CR, LLC /ID# 259335
Miami, Florida 33147
United StatesSite Not Available
Bliss Health /ID# 257827
Orlando, Florida 32806-3300
United StatesSite Not Available
Orlando Immunology Center /ID# 256931
Orlando, Florida 32803
United StatesSite Not Available
BayCare Medical Group, Inc. /ID# 256953
Tampa, Florida 33614-7101
United StatesSite Not Available
Baycare Medical Group - Tampa /ID# 256953
Tampa, Florida 33614
United StatesSite Not Available
The Pierone Research Institute /ID# 257022
Vero Beach, Florida 32960-6541
United StatesSite Not Available
Triple O Research Institute /ID# 256929
West Palm Beach, Florida 33407
United StatesSite Not Available
Midland Florida Clinical Research Center /ID# 257101
DeLand 4152890, Florida 4155751 32720-0920
United StatesSite Not Available
AIDS Healthcare Foundation (AHF) - Healthcare Center - Northpoint /ID# 256934
Fort Lauderdale 4155966, Florida 4155751 33308
United StatesSite Not Available
Midway Immunology and Research Center /ID# 256930
Ft. Pierce 4156018, Florida 4155751 34982
United StatesSite Not Available
Advanced Pharma CR, LLC /ID# 259335
Miami 4164138, Florida 4155751 33147
United StatesSite Not Available
Bliss Health /ID# 257827
Orlando 4167147, Florida 4155751 32806-3300
United StatesSite Not Available
Orlando Immunology Center /ID# 256931
Orlando 4167147, Florida 4155751 32803
United StatesSite Not Available
Baycare Medical Group - Tampa /ID# 256953
Tampa 4174757, Florida 4155751 33614
United StatesSite Not Available
The Pierone Research Institute /ID# 257022
Vero Beach 4176409, Florida 4155751 32960-6541
United StatesSite Not Available
Triple O Research Institute /ID# 256929
West Palm Beach 4177887, Florida 4155751 33407
United StatesSite Not Available
Emory Midtown Infectious Disease Clinic /ID# 258410
Atlanta, Georgia 30322
United StatesSite Not Available
Winship At Emory University Hospital Midtown /ID# 258410
Atlanta, Georgia 30308
United StatesSite Not Available
Infectious Disease Specialists of Atlanta /ID# 256955
Decatur, Georgia 30033
United StatesActive - Recruiting
Metro Infectious Disease Consultants, P.L.L.C /ID# 256955
Decatur, Georgia 30033
United StatesSite Not Available
Winship At Emory University Hospital Midtown /ID# 258410
Atlanta 4180439, Georgia 4197000 30308
United StatesSite Not Available
Metro Infectious Disease Consultants, P.L.L.C /ID# 256955
Decatur 4191124, Georgia 4197000 30033
United StatesSite Not Available
Howard Brown Health Center /ID# 257485
Chicago, Illinois 60613-2010
United StatesSite Not Available
Howard Brown Health Center /ID# 257485
Chicago 4887398, Illinois 4896861 60613-2010
United StatesSite Not Available
Claudia T. Martorell MD LLC dba The Research Institute /ID# 259155
Springfield, Massachusetts 01105-1406
United StatesSite Not Available
Claudia T. Martorell MD LLC dba The Research Institute /ID# 259155
Springfield 4951788, Massachusetts 6254926 01105-1406
United StatesSite Not Available
KC CARE Health Center - Midtown South /ID# 257178
Kansas City, Missouri 64111
United StatesSite Not Available
Kc Care Health Center /Id# 257178
Kansas City, Missouri 64111-2501
United StatesActive - Recruiting
KC CARE Health Center - Midtown South /ID# 257178
Kansas City 4393217, Missouri 4398678 64111
United StatesSite Not Available
Las Vegas Research Center /ID# 257619
Las Vegas, Nevada 89106
United StatesSite Not Available
Las Vegas Research Center /ID# 257619
Las Vegas 5506956, Nevada 5509151 89106
United StatesSite Not Available
Cooper University Health Care - Camden /ID# 258133
Camden, New Jersey 08103
United StatesSite Not Available
Cooper University Health Care /ID# 258133
Camden, New Jersey 08103-1438
United StatesActive - Recruiting
Saint Michael's Medical Center /ID# 258802
Newark, New Jersey 07102
United StatesSite Not Available
South Jersey Infectious Disease /ID# 257840
Somers Point, New Jersey 08244
United StatesSite Not Available
Cooper University Health Care - Camden /ID# 258133
Camden 4501018, New Jersey 5101760 08103
United StatesSite Not Available
Saint Michael's Medical Center /ID# 258802
Newark 5101798, New Jersey 5101760 07102
United StatesSite Not Available
South Jersey Infectious Disease /ID# 257840
Somers Point 4504186, New Jersey 5101760 08244
United StatesSite Not Available
Unmhsc /Id# 257533
Albuquerque, New Mexico 87102-2612
United StatesSite Not Available
Unmhsc /Id# 257533
Albuquerque 5454711, New Mexico 5481136 87102-2612
United StatesSite Not Available
Jacobi Medical Center /ID# 257849
Bronx, New York 10461
United StatesSite Not Available
Montefiore Medical Center /ID# 257792
Bronx, New York 10467
United StatesSite Not Available
SUNY Upstate Medical University /ID# 257847
Syracuse, New York 13215-2265
United StatesSite Not Available
Suny Upstate University Hospital Community Campus /ID# 257847
Syracuse, New York 13215
United StatesSite Not Available
Suny Upstate University Hospital Community Campus /ID# 257847
Syracuse 5140405, New York 5128638 13215
United StatesSite Not Available
Jacobi Medical Center /ID# 257849
The Bronx 5110266, New York 5128638 10461
United StatesSite Not Available
Montefiore Medical Center /ID# 257792
The Bronx 5110266, New York 5128638 10467
United StatesSite Not Available
Brody School of Medicine at East Carolina University /ID# 257544
Greenville, North Carolina 27834-3775
United StatesActive - Recruiting
East Carolina University - Brody School of Medicine /ID# 257544
Greenville, North Carolina 27834
United StatesSite Not Available
Atrium Health Wake Forest Baptist Medical Center /ID# 257542
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Wake Forest Health Sciences /ID# 257542
Winston-Salem, North Carolina 27103
United StatesActive - Recruiting
East Carolina University - Brody School of Medicine /ID# 257544
Greenville 4469160, North Carolina 4482348 27834
United StatesSite Not Available
Atrium Health Wake Forest Baptist Medical Center /ID# 257542
Winston-Salem 4499612, North Carolina 4482348 27157
United StatesSite Not Available
Central Texas Clinical Research /ID# 256920
Austin, Texas 78705-3326
United StatesSite Not Available
North Texas Infectious Diseases Consultants, P.A /ID# 257592
Dallas, Texas 75246
United StatesSite Not Available
Prism Health North Texas - Oak Cliff Health Center /ID# 256933
Dallas, Texas 75208-4599
United StatesSite Not Available
University of Texas Southwestern Medical Center /ID# 257551
Dallas, Texas 75390-7208
United StatesSite Not Available
Texas Center for Infectious Disease Associates /ID# 257183
Fort Worth, Texas 76104
United StatesSite Not Available
Texas Centers for Infectious Disease Associates /ID# 257183
Fort Worth, Texas 76104-3013
United StatesActive - Recruiting
The Crofoot Research Center, Inc /ID# 256921
Houston, Texas 77098-3900
United StatesSite Not Available
DCOL Center for Clinical Research /ID# 257093
Longview, Texas 75605
United StatesSite Not Available
Central Texas Clinical Research /ID# 256920
Austin 4671654, Texas 4736286 78705-3326
United StatesSite Not Available
North Texas Infectious Diseases Consultants, P.A /ID# 257592
Dallas 4684888, Texas 4736286 75246
United StatesSite Not Available
Prism Health North Texas - Oak Cliff Health Center /ID# 256933
Dallas 4684888, Texas 4736286 75208-4599
United StatesSite Not Available
University of Texas Southwestern Medical Center /ID# 257551
Dallas 4684888, Texas 4736286 75390-7208
United StatesSite Not Available
Texas Center for Infectious Disease Associates /ID# 257183
Fort Worth 4691930, Texas 4736286 76104
United StatesSite Not Available
The Crofoot Research Center, Inc /ID# 256921
Houston 4699066, Texas 4736286 77098-3900
United StatesSite Not Available
DCOL Center for Clinical Research /ID# 257093
Longview 4707814, Texas 4736286 75605
United StatesSite Not Available
Wisconsin Medical Center /ID# 257498
Milwaukee, Wisconsin 53226
United StatesSite Not Available
Wisconsin Medical Center /ID# 257498
Milwaukee 5263045, Wisconsin 5279468 53226
United StatesSite Not Available

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