Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    M19-939
Previous Study | Return to List | Next Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04223804
Recruitment Status : Recruiting
First Posted : January 10, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
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 HIV-1 infected participants undergoing ART interruption.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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

Experimental: Stage 2: Arm F
Participants will receive ABBV-181 dose D.
Drug: ABBV-181
Intravenous (IV) infusion
Other Name: Budigalimab




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 28 weeks ]
    Maximum Observed Concentration (Cmax) of ABBV-181.

  5. Time to Cmax (Tmax) [ Time Frame: Up to approximately 28 weeks ]
    Time to Cmax (Tmax) of ABBV-181.

  6. Observed Concentration (Ctrough) [ Time Frame: Up to approximately 28 weeks ]
    Observed Concentration (Ctrough) at the end of the 4-week dosing interval for ABBV-181.

  7. Area Under the Curve (AUCtau) [ Time Frame: Up to approximately 28 weeks ]
    Area Under the Curve (AUCtau) during the 4-week dosing interval for ABBV-181.

  8. Half-life (t1/2) [ Time Frame: Up to approximately 28 weeks ]
    Half-life (t1/2) of ABBV-181 for the second dose.



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.


Layout table for eligibility information
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) >= 18.0 to <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 >= 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 6 months 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).
  • 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.

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


Contacts
Layout table for location contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
Show Show 21 study locations
Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie
Layout table for additonal information
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: September 7, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
Layout table for MeSH terms
HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases