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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04223804
Recruitment Status : Completed
First Posted : January 10, 2020
Last Update Posted : March 9, 2023
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus (HIV) HIV Infection HIV-1 Drug: ABBV-181 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 30, 2020
Actual Primary Completion Date : February 27, 2023
Actual Study Completion Date : February 27, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Stage 1: Arm A
Participants will receive placebo.
 Drug: Placebo
Intravenous (IV) infusion
Experimental: Stage 1: Arm B
Participants will receive ABBV-181 dose A.
 Drug: ABBV-181
Intravenous (IV) Infusion
Other Name: Budigalimab
Experimental: Stage 1: Arm C
Participants will receive ABBV-181 dose B.
 Drug: ABBV-181
Intravenous (IV) Infusion
Other Name: Budigalimab
Placebo Comparator: Stage 2: Arm D
Participants will receive Placebo.
 Drug: Placebo
Intravenous (IV) infusion
Experimental: Stage 2: Arm E
Participants will receive ABBV-181 dose C.
 Drug: ABBV-181
Intravenous (IV) Infusion
Other Name: Budigalimab


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Study Drug-Related Adverse Events Grade 3 or Higher [ Time Frame: Up to approximately 44 weeks ]
    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.

  2. Number of Participants with Study Drug-Related Immune-Related Adverse Events (IRAE) [ Time Frame: Up to approximately 44 weeks ]
    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.

  3. Number of Participants with Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome [ Time Frame: Up to approximately 44 weeks ]
    Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome.

  4. Maximum Observed Concentration (Cmax) [ Time Frame: Up to approximately 36 weeks ]
    Maximum Observed Concentration (Cmax) of ABBV-181.

  5. Time to Cmax (Tmax) [ Time Frame: Up to approximately 36 weeks ]
    Time to Cmax (Tmax) of ABBV-181.

  6. Observed Concentration (Ctrough) [ Time Frame: Up to approximately 36 weeks ]
    Observed Concentration (Ctrough) at the end of the dosing intervals for ABBV-181.

  7. Area Under the Curve (AUCtau) [ Time Frame: Up to approximately 36 weeks ]
    Area Under the Curve (AUCtau) during the dosing intervals for ABBV-181.

  8. Half-life (t1/2) [ Time Frame: Up to approximately 36 weeks ]
    Half-life (t1/2) of ABBV-181 following the last dose.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04223804


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04223804    
Other Study ID Numbers: M19-939
2019-004866-16 ( EudraCT Number )
First Posted: January 10, 2020    Key Record Dates
Last Update Posted: March 9, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by AbbVie:
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
Additional relevant MeSH terms:
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HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
Immune System Diseases
Slow Virus Diseases