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

Phase 1

Completed

• Conditions: Human Immunodeficiency Virus (HIV); HIV-1; HIV Infection
• Interventions: Drug: Placebo; Drug: ABBV-181

• Registration Number: NCT04223804
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-10
• Study Start: 2020-01-30
• Primary Completion: 2023-02-27
• Study Completion: 2023-02-27
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stage 1: Arm A	Placebo	Participants will receive placebo.
Stage 1: Arm C	ABBV-181	Participants will receive ABBV-181 dose B.
Stage 2: Arm D	Placebo	Participants will receive Placebo.
Stage 2: Arm E	ABBV-181	Participants will receive ABBV-181 dose C.
Stage 1: Arm B	ABBV-181	Participants will receive ABBV-181 dose A.

Primary Outcome Measures

Name	Time	Method
Area Under the Curve (AUCtau)	Up to approximately 36 weeks	Area Under the Curve (AUCtau) during the dosing intervals for ABBV-181.
Half-life (t1/2)	Up to approximately 36 weeks	Half-life (t1/2) of ABBV-181 following the last dose.
Number of Participants with Study Drug-Related Adverse Events Grade 3 or Higher	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.
Number of Participants with Study Drug-Related Immune-Related Adverse Events (IRAE)	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.
Number of Participants with Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome	Up to approximately 44 weeks	Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome.
Maximum Observed Concentration (Cmax)	Up to approximately 36 weeks	Maximum Observed Concentration (Cmax) of ABBV-181.
Time to Cmax (Tmax)	Up to approximately 36 weeks	Time to Cmax (Tmax) of ABBV-181.
Observed Concentration (Ctrough)	Up to approximately 36 weeks	Observed Concentration (Ctrough) at the end of the dosing intervals for ABBV-181.

Trial Locations

Locations (23)

Franco Felizarta, Md /Id# 215721; 🇺🇸 Bakersfield, California, United States

Ruane Clinical Research Group /ID# 224866; 🇺🇸 Los Angeles, California, United States

Quest Clinical Research /ID# 215796; 🇺🇸 San Francisco, California, United States

Prism Health North Texas - Oak Cliff Health Center /ID# 214036; 🇺🇸 Dallas, Texas, United States

North TX Infectious Diseases /ID# 224861; 🇺🇸 Dallas, Texas, United States

Peter Shalit, M.D. /ID# 224870; 🇺🇸 Seattle, Washington, United States

Toronto General Hospital /ID# 218082; 🇨🇦 Toronto, Ontario, Canada

Puerto Rico AIDS Clinical Trials Unit CRS /ID# 213761; 🇵🇷 San Juan, Puerto Rico

Ottawa Hospital Research Institute /ID# 218083; 🇨🇦 Ottawa, Ontario, Canada

University of Miami, Miller School of Medicine /ID# 213833; 🇺🇸 Miami, Florida, United States

George Washington University Medical Faculty Associates /ID# 213893; 🇺🇸 Washington, District of Columbia, United States

Midway Immunology and Research /ID# 215587; 🇺🇸 Fort Pierce, Florida, United States

Clinical Research Puerto Rico /ID# 218821; 🇵🇷 San Juan, Puerto Rico

Saint Michael's Medical Center /ID# 228733; 🇺🇸 Newark, New Jersey, United States

The Royal Melbourne Hospital /ID# 215351; 🇦🇺 Parkville, Victoria, Australia

McGill Univ Clinical Research /ID# 218081; 🇨🇦 Montreal, Quebec, Canada

Orlando Immunology Center /ID# 243276; 🇺🇸 Orlando, Florida, United States

Triple O Research Institute /ID# 224863; 🇺🇸 West Palm Beach, Florida, United States

Be Well Medical Center /ID# 223841; 🇺🇸 Berkley, Michigan, United States

University of Cincinnati /ID# 215615; 🇺🇸 Cincinnati, Ohio, United States

St Vincent's Hospital Sydney /ID# 215354; 🇦🇺 Darlinghurst, New South Wales, Australia

Mayo Clinic - Rochester /ID# 217820; 🇺🇸 Rochester, Minnesota, United States

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