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

PHASE2CompletedINTERVENTIONAL
Enrollment

163

Participants

Timeline

Start Date

October 12, 2023

Primary Completion Date

September 22, 2025

Study Completion Date

September 22, 2025

Conditions
Human Immuno-deficiency Virus (HIV) Disease
Interventions
DRUG

Budigalimab

Intravenous (IV) Infusion

DRUG

Placebo for Budigalimab

IV Infusion

DRUG

ABBV-382

IV Infusion

DRUG

Placebo for ABBV-382

IV Infusion

DRUG

Budigalimab

Subcutaneous (SC) Injection

Trial Locations (80)

1000

CHU Saint Pierre /ID# 257447, Brussels

1070

Universite Libre de Bruxelles - Hopital Erasme /ID# 257433, Anderlecht

1200

Cliniques Universitaires UCL Saint-Luc /ID# 257444, Brussels

2001

Wits RHI Research Centre /ID# 257354, Johannesburg

2013

Perinatal HIV Research Unit (PHRU) /ID# 257350, Johannesburg

2092

Clinical HIV Research Unit (CHRU) /ID# 257358, Johannesburg

2193

Ezintsha Research Centre /ID# 257391, Johannesburg

9000

UZ Gent /ID# 257446, Ghent

10439

zibp-Zentrum fuer Infektiologie /ID# 257110, Berlin

10461

Jacobi Medical Center /ID# 257849, The Bronx

10467

Montefiore Medical Center /ID# 257792, The Bronx

13215

Suny Upstate University Hospital Community Campus /ID# 257847, Syracuse

20017

Washington Health Institute /ID# 259336, Washington D.C.

20132

IRCCS Ospedale San Raffaele /ID# 259820, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda /ID# 257410, Milan

27157

Atrium Health Wake Forest Baptist Medical Center /ID# 257542, Winston-Salem

27834

East Carolina University - Brody School of Medicine /ID# 257544, Greenville

28034

Hospital Universitario Ramon y Cajal /ID# 257266, Madrid

28046

Hospital Universitario La Paz /ID# 257170, Madrid

30033

Metro Infectious Disease Consultants, P.L.L.C /ID# 256955, Decatur

30308

Winship At Emory University Hospital Midtown /ID# 258410, Atlanta

32803

Orlando Immunology Center /ID# 256931, Orlando

33147

Advanced Pharma CR, LLC /ID# 259335, Miami

33308

AIDS Healthcare Foundation (AHF) - Healthcare Center - Northpoint /ID# 256934, Fort Lauderdale

33407

Triple O Research Institute /ID# 256929, West Palm Beach

33614

Baycare Medical Group - Tampa /ID# 256953, Tampa

34982

Midway Immunology and Research Center /ID# 256930, Ft. Pierce

41124

Azienda Ospedaliero-Universitaria di Modena /ID# 257411, Modena

53127

Universitaetsklinikum Bonn /ID# 257113, Bonn

53226

Wisconsin Medical Center /ID# 257498, Milwaukee

60596

Infektiologikum /ID# 257112, Frankfurt am Main

64111

KC CARE Health Center - Midtown South /ID# 257178, Kansas City

75012

AP-HP - Hopital Saint-Antoine /ID# 258090, Paris

75020

AP-HP - Hopital Tenon /ID# 258091, Paris

75246

North Texas Infectious Diseases Consultants, P.A /ID# 257592, Dallas

75605

DCOL Center for Clinical Research /ID# 257093, Longview

76104

Texas Center for Infectious Disease Associates /ID# 257183, Fort Worth

80131

Azienda Ospedaliera Universitaria Federico II /ID# 257412, Naples

89106

Las Vegas Research Center /ID# 257619, Las Vegas

90027

AHF Healthcare Center- Hollywood /ID# 257026, Los Angeles

90036

Ruane Clinical Research Group /ID# 256932, Los Angeles

90211

AHF Research Center /ID# 257025, Beverly Hills

92262

Palmtree Clinical Research Inc. /Id# 258409, Palm Springs

93301

Franco Felizarta, Md /Id# 256927, Bakersfield

94102

Optimus Medical /ID# 257182, San Francisco

35222-2309

University of Alabama at Birmingham, 1917 Research Clinic /ID# 257549, Birmingham

90813-3267

Long Beach Education and Research Consultants /ID# 257552, Long Beach

90028-6213

Los Angeles LGBT Center /ID# 258407, Los Angeles

94115-3037

Quest Clinical Research /ID# 256928, San Francisco

32720-0920

Midland Florida Clinical Research Center /ID# 257101, DeLand

32806-3300

Bliss Health /ID# 257827, Orlando

32960-6541

The Pierone Research Institute /ID# 257022, Vero Beach

60613-2010

Howard Brown Health Center /ID# 257485, Chicago

01105-1406

Claudia T. Martorell MD LLC dba The Research Institute /ID# 259155, Springfield

08103

Cooper University Health Care - Camden /ID# 258133, Camden

07102

Saint Michael's Medical Center /ID# 258802, Newark

08244

South Jersey Infectious Disease /ID# 257840, Somers Point

87102-2612

Unmhsc /Id# 257533, Albuquerque

78705-3326

Central Texas Clinical Research /ID# 256920, Austin

75208-4599

Prism Health North Texas - Oak Cliff Health Center /ID# 256933, Dallas

75390-7208

University of Texas Southwestern Medical Center /ID# 257551, Dallas

77098-3900

The Crofoot Research Center, Inc /ID# 256921, Houston

04037-030

Ricardo Diaz Scientific Solution /ID# 257335, São Paulo

V6Z 2T1

Spectrum Health Vancouver /ID# 260791, Vancouver

K1H 8L6

Ottawa Hospital Research Institute /ID# 256993, Ottawa

M5G 2C4

Toronto General Hospital /ID# 256994, Toronto

H4A 3J1

McGill University Health Centre - Glen Site /ID# 256992, Montreal

G1V 4G2

CHU de Quebec-Université Laval hôpital CHUL /ID# 261611, Québec

S4P 0W5

Regina General Hospital - Infectious Disease Clinic /ID# 260243, Regina

460-0001

NHO Nagoya Medical Center /ID# 261433, Nagoya

540-0006

National Hospital Organization Osaka National Hospital /ID# 261520, Osaka

108-8639

IMSUT Hospital, The Institute of Medical Science, The University of Tokyo /ID# 265344, Tokyo

85-030

Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 259184, Bydgoszcz

80-405

Punkt Zdrowia /ID# 257950, Gdansk

00909-1711

Clinical Research Puerto Rico /ID# 256956, San Juan

00909

HOPE Clinical Research /ID# 257487, San Juan

08916

Hospital Universitario Germans Trias i Pujol /ID# 257268, Badalona

08036

Hospital Clinic de Barcelona /ID# 257269, Barcelona

NW3 2QG

Royal Free Hospital /ID# 257453, London

SE1 9RT

Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 257761, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AbbVie

INDUSTRY