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Monoclonal Antibodies

Budigalimab + ABBV-382 for HIV/AIDS

Phase 2
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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]).
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 52 weeks
Awards & highlights

Study Summary

This trial is testing investigational drugs for the treatment of HIV. 140 people with HIV will receive 4 doses of IV budigalimab or placebo and 3 doses of IV ABBV-382 or placebo for 8 weeks. They will be monitored for up to 52 weeks.

Who is the study for?
Adults living with HIV on stable ART for at least a year, with CD4+ T cell counts >= 500 cells/μL and undetectable viral load for 6 months can join. They must be in good health as determined by medical exams. Those with significant health risks, a history of low CD4+ counts (<=200 cells/μL), or other conditions that may risk their safety or study integrity cannot participate.Check my eligibility
What is being tested?
The trial is testing Budigalimab and ABBV-382, potential new treatments for HIV. Participants will stop their usual ART and receive either the investigational drugs or placebos via IV over an 8-week period, followed by monitoring without ART for up to 52 weeks to assess changes in disease activity and drug behavior in the body.See study design
What are the potential side effects?
Specific side effects are not listed but participants will be closely monitored for any adverse reactions during the trial due to stopping standard ART and receiving new treatments. Regular medical assessments, blood tests, and questionnaires will help track any negative effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been on HIV medication for over a year and my current treatment does not include NNRTIs.
Select...
My CD4+ T cell count has been above 500 for the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with Viral Control Without Antiretroviral Therapy (ART) Restart
Secondary outcome measures
Median Peak Viral Load (At Rebound) Prior to Re-Starting ART
Median Time to First Rebound to >= 1000 Copies/mL During ART Interruption

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm E: Budigalimab + ABBV-382 Dose AExperimental Treatment2 Interventions
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.
Group II: Arm D: Budigalimab + ABBV-382 Dose BExperimental Treatment2 Interventions
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.
Group III: Arm C: ABBV-382 Dose AExperimental Treatment2 Interventions
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.
Group IV: Arm B: BudigalimabExperimental Treatment2 Interventions
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.
Group V: Arm A: PlaceboPlacebo Group2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo for ABBV-382
2021
Completed Phase 1
~60
Budigalimab
2021
Completed Phase 1
~170
ABBV-382
2021
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,250 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,969 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Budigalimab attained regulatory authorization from the FDA?

"While there is supporting evidence about the safety of Arm B: Budigalimab, no data exists that provides any support for its efficacy. Therefore we have rated it 2/3 on our scale."

Answered by AI

Is this research protocol enrolling individuals aged 20 and over?

"Patients that meet the requirements of this trial must be between 18 to 70 years old. Additionally, 153 trials are available for minors and 364 studies target seniors above 65."

Answered by AI

Is recruitment into this experiment still ongoing?

"Yes, according to the clinicaltrials.gov website activity log, this trial which was originally made public on December 10th 2023 is still recruiting participants for a total of 140 volunteers across 16 different sites."

Answered by AI

What is the total enrollment for this medical experiment?

"The trial's sponsor, AbbVie must recruit 140 eligible patients to ensure the success of this experiment. These participants can be found at AHF Research Center /ID# 257025 in Beverly Hills, Florida and Long Beach Education and Research Consultants / ID# 257552 in Long Beach, Texas."

Answered by AI

Are there several medical facilities administering this trial in the metropolitan area?

"This study is currently underway in 16 different locations, including AHF Research Center /ID# 257025 in Beverly Hills, Long Beach Education and Research Consultants /ID# 257552 in Long Beach, and AHF Healthcare Centre- Hollywood ID# 257026 situated within Los Angeles."

Answered by AI

What are the qualifications for participating in this clinical experiment?

"This trial seeks to recruit 140 HIV/AIDS patients aged 18-70 who meet the following medical requirements: general good health, negative human immuno-deficiency virus (HIV)-2 antibody (Ab), must be on antiretroviral therapy (ART) for at least 12 months prior to screening and 8 weeks before enrollment begins, CD4+ T cell count >= 500 cells/μL in the past year, plasma HIV-1 ribonucleic acid (RNA) that is below a certain limit of quantitation."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
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
2023. "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. https://clinicaltrials.gov/ct2/show/NCT06032546.
All > Paid Studies Las Vegas > Hiv
~86 spots leftby Apr 2025
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