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

Phase 2

Active, not recruiting

• Conditions: Human Immuno-deficiency Virus (HIV) Disease
• Interventions: Drug: Placebo for Budigalimab; Drug: Budigalimab; Drug: Placebo for ABBV-382; Drug: ABBV-382

• Registration Number: NCT06032546
• Lead Sponsor: AbbVie

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 available

Study Timeline

• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-09-05
• Study First Posted: 2023-09-13
• Study Start: 2023-10-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 163

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Placebo	Placebo for Budigalimab	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.
Arm A: Placebo	Placebo for ABBV-382	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.
Arm B: Budigalimab Dose A	Budigalimab	Participants will receive budigalimab Dose A on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 matching placebo Day 1 and Weeks 4 and 8.
Arm B: Budigalimab Dose A	Placebo for ABBV-382	Participants will receive budigalimab Dose A on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 matching placebo Day 1 and Weeks 4 and 8.
Arm C: ABBV-382 Dose A	Placebo for Budigalimab	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.
Arm C: ABBV-382 Dose A	ABBV-382	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.
Arm D: Budigalimab Dose A + ABBV-382 Dose B	Budigalimab	Participants will receive budigalimab Dose A on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose B on Day 1 and Weeks 4 and 8.
Arm D: Budigalimab Dose A + ABBV-382 Dose B	ABBV-382	Participants will receive budigalimab Dose A on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose B on Day 1 and Weeks 4 and 8.
Arm E: Budigalimab Dose A + ABBV-382 Dose A	Budigalimab	Participants will receive budigalimab Dose A on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose A on Day 1 and Weeks 4 and 8.
Arm E: Budigalimab Dose A + ABBV-382 Dose A	ABBV-382	Participants will receive budigalimab Dose A on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose A on Day 1 and Weeks 4 and 8.
Arm F: Budigalimab Dose B	Budigalimab	Participants will receive open-label budigalimab Dose B on Day 1 and Weeks 2, 4, and 6 (Note, no ABBV-382 or placebo will be administered).

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Viral Control Without Antiretroviral Therapy (ART) Restart	Week 24	Percentage of participants who achieve viral control (viral load \< 1000 copies/mL) without ART restart at Week 24.
Number of Participants with Adverse Events (AEs)	Up to approximately Week 112	An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Secondary Outcome Measures

Name	Time	Method
Median Peak Viral Load (At Rebound) Prior to Re-Starting ART	Up to 112 weeks	The median peak viral load (at rebound) before re-starting ART.
Median Time to First Rebound to >= 1000 Copies/mL During ART Interruption	Up to 112 weeks	The median time to rebound to \>= 1000 copies/mL during ART interruption.

Trial Locations

Locations (80)

University of Alabama at Birmingham, 1917 Research Clinic /ID# 257549; 🇺🇸 Birmingham, Alabama, United States

Franco Felizarta, Md /Id# 256927; 🇺🇸 Bakersfield, California, United States

AHF Research Center /ID# 257025; 🇺🇸 Beverly Hills, California, United States

Long Beach Education and Research Consultants /ID# 257552; 🇺🇸 Long Beach, California, United States

AHF Healthcare Center- Hollywood /ID# 257026; 🇺🇸 Los Angeles, California, United States

Los Angeles LGBT Center /ID# 258407; 🇺🇸 Los Angeles, California, United States

Ruane Clinical Research Group /ID# 256932; 🇺🇸 Los Angeles, California, United States

Palmtree Clinical Research Inc. /Id# 258409; 🇺🇸 Palm Springs, California, United States

Optimus Medical /ID# 257182; 🇺🇸 San Francisco, California, United States

Quest Clinical Research /ID# 256928; 🇺🇸 San Francisco, California, United States

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