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Completed

NCT Number: NCT04223804

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

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.

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Key information

Conditions

Human Immunodeficiency Virus (HIV) Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infection HIV Infections HIV-1 Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Holdsworth House Medical Practice /ID# 215352, Darlinghurst, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-181

Drug

Intravenous (IV) Infusion

Other names: Budigalimab

Placebo

Drug

Intravenous (IV) infusion

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2020
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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