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A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1

Primary Purpose

Human Immunodeficiency Virus (HIV), HIV Infection, HIV-1

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ABBV-181
Placebo
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus (HIV) focused on measuring Human Immunodeficiency Virus (HIV), HIV Infection, HIV-1, ABBV-181, Analytical Treatment Interruption, Budigalimab, Programmed cell death protein-1 (PD-1), Anti-PD-1 Antibody

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Body Mass Index (BMI) between 18.0 and 35 kg/m2.
  • HIV-1 infected 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.
  • Meets HIV-specific laboratory parameters as below:

    • Plasma HIV-1 RNA below lower limit of quantification (LLOQ) at screening and at least 6 months prior to screening.
    • CD4+ T cell count >= 500 cells/uL at screening and at least once during the 12 months prior to screening.
    • CD4+ T cell nadir of >= 200 cells/uL during chronic infection.
  • Willing to undergo ART interruption.
  • Agrees to use an effective barrier method of protection (male and/or female condoms) during sexual activity for protection against HIV-1 transmission throughout the entire study.

Exclusion Criteria:

  • Known resistance to at least 2 classes of ART.
  • History of AIDS-defining illness.
  • Active or suspected malignancy or history of malignancy (other than basal cell skin cancer or cervical carcinoma in situ) in the past 5 years.
  • History of or active immunodeficiency (other than HIV).
  • Active autoimmune disease or history of autoimmune disease that has required systemic treatment.
  • Prior receipt of immunomodulatory or immunosuppressive (including intravenous infusion or oral steroids at any dose, but excluding steroids that are inhaled, topical or by local injection) therapy within 24 weeks prior to the first dose of study drug.
  • Prior therapy/exposure to ABBV-181 or any other immune checkpoint inhibitor.
  • Current hepatitis B virus or hepatitis C virus infection.
  • Clinically significant medical disorders that might expose the participants to undue risk of harm, confound study outcomes, or prevent the participant from completing the study (including but not limited to significant or unstable cardiac, neurologic or pulmonary disease, chronic active infectious disease except for HIV, chronic liver disease, poorly controlled diabetes mellitus and history of Stevens Johnson Syndrome toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS)).
  • Known psychiatric or substance abuse disorders that would interfere with adherence to study requirements.
  • Female participants must not be pregnant, breastfeeding, or considering becoming pregnant during the study.

Sites / Locations

  • Franco Felizarta, Md /Id# 215721
  • Ruane Clinical Research Group /ID# 224866
  • Quest Clinical Research /ID# 215796
  • George Washington University Medical Faculty Associates /ID# 213893
  • Midway Immunology and Research /ID# 215587
  • University of Miami, Miller School of Medicine /ID# 213833
  • Orlando Immunology Center /ID# 243276
  • Triple O Research Institute /ID# 224863
  • Be Well Medical Center /ID# 223841
  • Mayo Clinic - Rochester /ID# 217820
  • Saint Michael's Medical Center /ID# 228733
  • University of Cincinnati /ID# 215615
  • Prism Health North Texas - Oak Cliff Health Center /ID# 214036
  • North TX Infectious Diseases /ID# 224861
  • Peter Shalit, M.D. /ID# 224870
  • Holdsworth House Medical Practice /ID# 215352
  • St Vincent's Hospital Sydney /ID# 215354
  • The Royal Melbourne Hospital /ID# 215351
  • Ottawa Hospital Research Institute /ID# 218083
  • Toronto General Hospital /ID# 218082
  • McGill Univ Clinical Research /ID# 218081
  • Clinical Research Puerto Rico /ID# 218821
  • Puerto Rico AIDS Clinical Trials Unit CRS /ID# 213761

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Stage 1: Arm A

Stage 1: Arm B

Stage 1: Arm C

Stage 2: Arm D

Stage 2: Arm E

Arm Description

Participants will receive placebo.

Participants will receive ABBV-181 dose A.

Participants will receive ABBV-181 dose B.

Participants will receive Placebo.

Participants will receive ABBV-181 dose C.

Outcomes

Primary Outcome Measures

Number of Participants with Study Drug-Related Adverse Events Grade 3 or Higher
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of the study drug as either having a reasonable possibility or no reasonable possibility. AEs are given a grade from 1-5 with Grade 3 being severe but not life-threatening and requiring hospitalization, Grade 4 being life-threatening requiring immediate intervention and Grade 5 being death related to an AE.
Number of Participants with Study Drug-Related Immune-Related Adverse Events (IRAE)
Assessed using the American Society of Clinical Oncology (ASCO) IRAE management guidelines (which utilizes the NIH CTCAE grading scale) but modified, as applicable, according to the NIH Division of AIDS (DAIDS) (v2.1) AE grading scale.
Number of Participants with Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome
Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome.
Maximum Observed Concentration (Cmax)
Maximum Observed Concentration (Cmax) of ABBV-181.
Time to Cmax (Tmax)
Time to Cmax (Tmax) of ABBV-181.
Observed Concentration (Ctrough)
Observed Concentration (Ctrough) at the end of the dosing intervals for ABBV-181.
Area Under the Curve (AUCtau)
Area Under the Curve (AUCtau) during the dosing intervals for ABBV-181.
Half-life (t1/2)
Half-life (t1/2) of ABBV-181 following the last dose.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2020
Last Updated
March 7, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04223804
Brief Title
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of ABBV-181 in HIV-1 Infected Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 30, 2020 (Actual)
Primary Completion Date
February 27, 2023 (Actual)
Study Completion Date
February 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will be conducted in two stages and will test the safety/tolerability, pharmacokinetics (how the body handles study drug) and pharmacodynamics (effects on the immune system and the virus) of the study drug ABBV-181 in Human immunodeficiency virus (HIV)-1 infected participants undergoing Antiretroviral therapy (ART) interruption.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus (HIV), HIV Infection, HIV-1
Keywords
Human Immunodeficiency Virus (HIV), HIV Infection, HIV-1, ABBV-181, Analytical Treatment Interruption, Budigalimab, Programmed cell death protein-1 (PD-1), Anti-PD-1 Antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stage 1: Arm A
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo.
Arm Title
Stage 1: Arm B
Arm Type
Experimental
Arm Description
Participants will receive ABBV-181 dose A.
Arm Title
Stage 1: Arm C
Arm Type
Experimental
Arm Description
Participants will receive ABBV-181 dose B.
Arm Title
Stage 2: Arm D
Arm Type
Placebo Comparator
Arm Description
Participants will receive Placebo.
Arm Title
Stage 2: Arm E
Arm Type
Experimental
Arm Description
Participants will receive ABBV-181 dose C.
Intervention Type
Drug
Intervention Name(s)
ABBV-181
Other Intervention Name(s)
Budigalimab
Intervention Description
Intravenous (IV) Infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenous (IV) infusion
Primary Outcome Measure Information:
Title
Number of Participants with Study Drug-Related Adverse Events Grade 3 or Higher
Description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of the study drug as either having a reasonable possibility or no reasonable possibility. AEs are given a grade from 1-5 with Grade 3 being severe but not life-threatening and requiring hospitalization, Grade 4 being life-threatening requiring immediate intervention and Grade 5 being death related to an AE.
Time Frame
Up to approximately 44 weeks
Title
Number of Participants with Study Drug-Related Immune-Related Adverse Events (IRAE)
Description
Assessed using the American Society of Clinical Oncology (ASCO) IRAE management guidelines (which utilizes the NIH CTCAE grading scale) but modified, as applicable, according to the NIH Division of AIDS (DAIDS) (v2.1) AE grading scale.
Time Frame
Up to approximately 44 weeks
Title
Number of Participants with Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome
Description
Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome.
Time Frame
Up to approximately 44 weeks
Title
Maximum Observed Concentration (Cmax)
Description
Maximum Observed Concentration (Cmax) of ABBV-181.
Time Frame
Up to approximately 36 weeks
Title
Time to Cmax (Tmax)
Description
Time to Cmax (Tmax) of ABBV-181.
Time Frame
Up to approximately 36 weeks
Title
Observed Concentration (Ctrough)
Description
Observed Concentration (Ctrough) at the end of the dosing intervals for ABBV-181.
Time Frame
Up to approximately 36 weeks
Title
Area Under the Curve (AUCtau)
Description
Area Under the Curve (AUCtau) during the dosing intervals for ABBV-181.
Time Frame
Up to approximately 36 weeks
Title
Half-life (t1/2)
Description
Half-life (t1/2) of ABBV-181 following the last dose.
Time Frame
Up to approximately 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body Mass Index (BMI) between 18.0 and 35 kg/m2. HIV-1 infected 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. Meets HIV-specific laboratory parameters as below: Plasma HIV-1 RNA below lower limit of quantification (LLOQ) at screening and at least 6 months prior to screening. CD4+ T cell count >= 500 cells/uL at screening and at least once during the 12 months prior to screening. CD4+ T cell nadir of >= 200 cells/uL during chronic infection. Willing to undergo ART interruption. Agrees to use an effective barrier method of protection (male and/or female condoms) during sexual activity for protection against HIV-1 transmission throughout the entire study. Exclusion Criteria: Known resistance to at least 2 classes of ART. History of AIDS-defining illness. Active or suspected malignancy or history of malignancy (other than basal cell skin cancer or cervical carcinoma in situ) in the past 5 years. History of or active immunodeficiency (other than HIV). Active autoimmune disease or history of autoimmune disease that has required systemic treatment. Prior receipt of immunomodulatory or immunosuppressive (including intravenous infusion or oral steroids at any dose, but excluding steroids that are inhaled, topical or by local injection) therapy within 24 weeks prior to the first dose of study drug. Prior therapy/exposure to ABBV-181 or any other immune checkpoint inhibitor. Current hepatitis B virus or hepatitis C virus infection. Clinically significant medical disorders that might expose the participants to undue risk of harm, confound study outcomes, or prevent the participant from completing the study (including but not limited to significant or unstable cardiac, neurologic or pulmonary disease, chronic active infectious disease except for HIV, chronic liver disease, poorly controlled diabetes mellitus and history of Stevens Johnson Syndrome toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS)). Known psychiatric or substance abuse disorders that would interfere with adherence to study requirements. Female participants must not be pregnant, breastfeeding, or considering becoming pregnant during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Franco Felizarta, Md /Id# 215721
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Ruane Clinical Research Group /ID# 224866
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Quest Clinical Research /ID# 215796
City
San Francisco
State/Province
California
ZIP/Postal Code
94115-3037
Country
United States
Facility Name
George Washington University Medical Faculty Associates /ID# 213893
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037-3201
Country
United States
Facility Name
Midway Immunology and Research /ID# 215587
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Facility Name
University of Miami, Miller School of Medicine /ID# 213833
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Orlando Immunology Center /ID# 243276
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Triple O Research Institute /ID# 224863
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407-3100
Country
United States
Facility Name
Be Well Medical Center /ID# 223841
City
Berkley
State/Province
Michigan
ZIP/Postal Code
48072-3046
Country
United States
Facility Name
Mayo Clinic - Rochester /ID# 217820
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
Saint Michael's Medical Center /ID# 228733
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
University of Cincinnati /ID# 215615
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States
Facility Name
Prism Health North Texas - Oak Cliff Health Center /ID# 214036
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208-4599
Country
United States
Facility Name
North TX Infectious Diseases /ID# 224861
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Peter Shalit, M.D. /ID# 224870
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104-3595
Country
United States
Facility Name
Holdsworth House Medical Practice /ID# 215352
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
St Vincent's Hospital Sydney /ID# 215354
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
The Royal Melbourne Hospital /ID# 215351
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Ottawa Hospital Research Institute /ID# 218083
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Toronto General Hospital /ID# 218082
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
McGill Univ Clinical Research /ID# 218081
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2P4
Country
Canada
Facility Name
Clinical Research Puerto Rico /ID# 218821
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Puerto Rico AIDS Clinical Trials Unit CRS /ID# 213761
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1

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