A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion of Budigalimab and/or ABBV-382

• ClinicalTrials.gov Identifier: NCT06032546
• Recruitment Status: Recruiting
• First Posted: September 13, 2023
• Last Update Posted: May 14, 2024
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Tracking Information

• First Submitted Date: September 5, 2023
• First Posted Date: September 13, 2023
• Last Update Posted Date: May 14, 2024
• Actual Study Start Date: October 12, 2023
• Estimated Primary Completion Date: April 28, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 5, 2023)

Percentage of Participants with Viral Control Without Antiretroviral Therapy (ART) Restart [ Time Frame: Week 24 ]

Percentage of participants who achieve viral control (viral load < 1000 copies/mL) without ART restart at Week 24.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 5, 2023)

• Median Peak Viral Load (At Rebound) Prior to Re-Starting ART [ Time Frame: Up to 52 weeks ]
  The median peak viral load (at rebound) before re-starting ART.
• Median Time to First Rebound to >= 1000 Copies/mL During ART Interruption [ Time Frame: Up to 52 weeks ]
  The median time to rebound to >= 1000 copies/mL during ART interruption.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion of Budigalimab and/or ABBV-382
• Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Budigalimab and/or ABBV-382 in People Living With HIV on Stable Antiretroviral Therapy Undergoing Analytical Treatment Interruption

Brief Summary

Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency Syndrome (AIDS). HIV disease is considered to be a chronic disease requiring lifelong therapy. The purpose of this study is to assess change in disease activity, adverse events, tolerability, and how the drug moves through the body.

Budigalimab and ABBV-382 are investigational drugs being developed for the treatment of HIV disease. Participants are placed in 1 of 5 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 7 chance that participants will be assigned to placebo (A placebo is not a drug and it is not expected to have any chemical effects on your body and it is not designed to treat any disease or illness). Approximately 140 adult participants living with HIV disease on stable antiretroviral therapy (ART) willing to undergo Analytical Treatment Interruption (ATI) will be enrolled at approximately 90 sites worldwide.

Participants will receive 4 doses of IV budigalimab or placebo combined with 3 doses of IV ABBV-382 or placebo for an 8 week dosing period. Participants need to be stable on antiretroviral therapy to participate in the study. If participant qualifies to the study, on the day they receive the first injection, participants will be asked to stop antiretroviral medications (also referred to as analytical treatment interruption or ATI) for 52 weeks or until meeting specific criteria to restart antiretroviral medications. Participants will undergo a closely monitored ART interruption. Protocol-defined ART restart criteria includes participant's request. Participants will be followed for up to approximately 52 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. There will be an option for virtual or home health visits for some of the follow-up visits. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Human Immuno-deficiency Virus (HIV) Disease

Intervention

• Drug: Budigalimab
  IV
  Other Name: ABBV-181
• Drug: Placebo for Budigalimab
  IV
• Drug: ABBV-382
  IV
• Drug: Placebo for ABBV-382
  IV

Study Arms

• Placebo Comparator: Arm A: Placebo
  Participants will receive budigalimab placebo on Day 1, and Weeks 2, 4, and 6 in combination with ABBV-382 matching placebo on Day 1 and Weeks 4 and 8.
  Interventions:

  • Drug: Placebo for Budigalimab
  • Drug: Placebo for ABBV-382
• Experimental: Arm B: Budigalimab
  Participants will receive budigalimab on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 matching placebo Day 1 and Weeks 4 and 8.
  Interventions:

  • Drug: Budigalimab
  • Drug: Placebo for ABBV-382
• Experimental: Arm C: ABBV-382 Dose A
  Participants will receive budigalimab placebo on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose A on Day 1 and Weeks 4 and 8.
  Interventions:

  • Drug: Placebo for Budigalimab
  • Drug: ABBV-382
• Experimental: Arm D: Budigalimab + ABBV-382 Dose B
  Participants will receive budigalimab on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose B on Day 1 and Weeks 4 and 8.
  Interventions:

  • Drug: Budigalimab
  • Drug: ABBV-382
• Experimental: Arm E: Budigalimab + ABBV-382 Dose A
  Participants will receive budigalimab on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose A on Day 1 and Weeks 4 and 8.
  Interventions:

  • Drug: Budigalimab
  • Drug: ABBV-382

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 5, 2023): 140
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 7, 2026
• Estimated Primary Completion Date: April 28, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• A condition of general good health in the opinion of the investigator, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
• Must be 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 (current ART regimen cannot include an Non-nucleoside reverse transcriptase inhibitor [NNRTI]).
• Negative human immuno-deficiency virus (HIV)-2 antibody (Ab)
• CD4+ T cell count >= 500 cells/μL at screening and no known evidence of CD4+ T cell count < 500 cells/μL in the last 12 months prior to screening
• Participant must have plasma HIV-1 ribonucleic acid (RNA) below the lower limit of quantitation (LLOQ) at screening and for at least 12 months prior to screening

Exclusion Criteria:

• Prior exposure to long acting antiretrovirals within 24 weeks or within a period defined by 5 half-lives, whichever is longer, prior to randomization and prior to the first dose of study drug.
• History of cluster of differentiation 4 (CD4+) T cell nadir of <= 200 cells/μL during chronic HIV infection.
• History of medical disorders (other than HIV-1 infection) that, in the opinion of the investigator, might expose the participant to undue risk of harm, confound study outcomes or prevent the participant from completing the study.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: ABBVIE CALL CENTER; 844-663-3742; abbvieclinicaltrials@abbvie.com

• Listed Location Countries: Belgium, Canada, France, Germany, Japan, Puerto Rico, Spain, United States

Administrative Information

• NCT Number: NCT06032546
• Other Study ID Numbers: M19-965; 2023-505900-53-00 ( Other Identifier: EU CT )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• URL: https://vivli.org/ourmember/abbvie/

• Current Responsible Party: AbbVie
• Original Responsible Party: Same as current
• Current Study Sponsor: AbbVie
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: ABBVIE INC.; AbbVie

• PRS Account: AbbVie
• Verification Date: May 2024