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Study to Evaluate the Safety and How the Body Handles a Single Dose of Subcutaneous (SC) and Intravenous (IV) Budigalimab in Adult Participants Living With Human Immunodeficiency Virus (HIV)

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: NCT04799353
Recruitment Status : Active, not recruiting
First Posted : March 16, 2021
Last Update Posted : April 29, 2022
Information provided by (Responsible Party):

Brief Summary:

This study will evaluate how safe Budigalimab is and how it moves within the body in adult participants with HIV-1 infection.

Budigalimab is an investigational drug being evaluated for the treatment of Human Immunodeficiency Virus. Study participants will be assigned to one of the 4 treatment groups and will receive a single dose of Budigalimab or placebo subcutaneous (SC) and intravenous (IV). Around 32 participants 18-65 years of age living with Human Immunodeficiency Virus will be enrolled in the study in approximately 9 sites worldwide.

Each participant will receive single dose of SC and IV Budigalimab and/or Placebo on day 1 and will be followed for 24 weeks.

Participants will attend weekly to every two and every four weeks visits during the study at a hospital. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects. There may be higher treatment burden for participants in this trial.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus (HIV) Drug: Budigalimab Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-controlled Single-Dose Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous and Intravenous Administration of Budigalimab in Adult People Living With HIV-1 (PLWH)
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : October 2, 2022
Estimated Study Completion Date : October 2, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Group 1: Placebo SC + Placebo IV
Participants will receive Subcutaneous (SC) Placebo, followed by Intravenous (IV) Placebo.
Drug: Placebo
Subcutaneous (SC)

Drug: Placebo
Intravenous (IV)

Experimental: Group 2: Budigalimab (SC) + Placebo IV
Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo.
Drug: Budigalimab
Subcutaneous (SC)
Other Name: ABBV-181

Drug: Placebo
Intravenous (IV)

Experimental: Group 3: Budigalimab SC + Placebo IV
Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo.
Drug: Budigalimab
Subcutaneous (SC)
Other Name: ABBV-181

Drug: Placebo
Intravenous (IV)

Experimental: Group 4: Placebo SC + Budigalimab IV
Participants will receive Subcutaneous (SC) Placebo, followed by IV Budigalimab.
Drug: Placebo
Subcutaneous (SC)

Drug: Budigalimab
Intravenous (IV)
Other Name: ABBV-181

Primary Outcome Measures :
  1. Number of Participants Experiencing Study Drug-Related Grade 3 or Higher Adverse Events (AEs) [ Time Frame: Up to approximately 24 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 24 weeks ]
    Assessed using the American Society of Clinical Oncology (ASCO) IRAE management guidelines [which utilizes the National Institutes of Health (NIH) Common Terminology Criteria for Adverse Events (CTCAE) grading scale] but modified, as applicable, according to the NIH Division of AIDS (DAIDS) (v2.1) AE grading scale.

  3. Maximum Serum Concentration (Cmax) [ Time Frame: Up to approximately 24 weeks ]
    Maximum Serum Concentration (Cmax) of Budigalimab.

  4. Time to Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Up to approximately 24 weeks ]
    Time to Maximum Observed Plasma Concentration (Tmax) of Budigalimab.

  5. Area Under the Plasma Concentration-time Curve (AUC) of Budigalimab in Plasma [ Time Frame: Up to approximately 24 weeks ]
    Area Under the Plasma Concentration-time Curve (AUC).

  6. Terminal Phase Elimination Half-life (t1/2) of Budigalimab in Plasma [ Time Frame: Up to approximately 24 weeks. ]
    Terminal phase elimination half-life (t1/2)

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

Inclusion Criteria:

  • Condition of generally good health, body mass index ≥ 18.0 to < 35.0 kg/m2.
  • Laboratory values must meet acceptable criteria.
  • Human Immunodeficiency Virus (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.
  • CD4 cell count ≥ 450 cells/μL at Screening and during the 12 months prior to Screening.
  • Plasma HIV-1 RNA below the lower limit of quantification at Screening and at least 6 months prior to Screening.
  • Participants agreeing to use an effective barrier method of protection (male and/or female condom) during sexual activity from Study Day 1 through last study visit for the purposes of prevention of HIV transmission.

Exclusion Criteria:

  • Participants with signs/symptoms associated with SARS-CoV-2 infection OR Current SARS-CoV-2 infection by any viral nucleic acid test completed within 7 days prior to the Day 1 dose.
  • Participants having history or ongoing diagnosis of acquired immunodeficiency syndrome (AIDS)-defining illness.
  • Participants having history of or active immunodeficiency (other than HIV).
  • Participants having active autoimmune disease or history of autoimmune disease that has required systemic treatment.
  • Prior therapy/exposure to budigalimab or any other immune checkpoint inhibitor [e.g., anti-programmed cell death protein 1(PD-1), anti-PD-L1, anti-PD-L2, anti-CTLA4].
  • Participants having clinically significant medical disorders that might expose the subjects to undue risk of harm, confound study outcomes, or prevent the subject from completing the study.
  • Participants having active or suspected malignancy or history of malignancy (other than basal cell skin cancer or cervical carcinoma in situ) in the past 5 years.
  • Participants with history of or active tuberculosis (TB) at screening.
  • Participants having known psychiatric or substance abuse disorders that would interfere with adherence to study requirements.
  • Participants who have received immunomodulatory or immunosuppressive (including IV/orally administered [PO] steroids at any dose, but excluding steroids that are inhaled, topical or via local injection) therapy within 24 weeks prior to the first dose of study drug.

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): NCT04799353

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United States, California
Franco Felizarta, Md /Id# 223931
Bakersfield, California, United States, 93301
Ruane Clinical Research Group /ID# 224496
Los Angeles, California, United States, 90036
Quest Clinical Research /ID# 223925
San Francisco, California, United States, 94115-3037
United States, Texas
Central Texas Clinical Research /ID# 223937
Austin, Texas, United States, 78705-3326
St. Hope Foundation, Inc. /ID# 224492
Bellaire, Texas, United States, 77401-4528
North TX Infectious Diseases /ID# 224494
Dallas, Texas, United States, 75246
The Crofoot Research Center, Inc /ID# 224493
Houston, Texas, United States, 77098-3900
United States, Washington
Peter Shalit, M.D. /ID# 224801
Seattle, Washington, United States, 98104-3595
Puerto Rico
Ponce Medical School Foundation /ID# 224230
Ponce, Puerto Rico, 00716-0377
Puerto Rico AIDS Clinical Trials Unit CRS /ID# 223936
San Juan, Puerto Rico, 00935
Sponsors and Collaborators
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Study Director: ABBVIE INC. AbbVie
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04799353    
Other Study ID Numbers: M19-972
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: April 29, 2022
Last Verified: April 2022
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.: No
Keywords provided by AbbVie:
Human Immunodeficiency Virus (HIV)
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases