What side effects are associated with this type of intervention?

Common side effects of HIV/AIDS treatments, particularly those involving monoclonal antibodies like Budigalimab and investigational drugs such as ABBV-382, include infusion-related reactions, which may manifest as fever, chills, rash, and fatigue. Other potential side effects can include gastrointestinal issues like nausea and diarrhea, as well as immune-related adverse events such as colitis, hepatitis, and endocrinopathies. Patients may also experience general symptoms like headache, dizziness, and muscle pain. It is important for patients to be closely monitored for these side effects during treatment.

What prior FDA approvals exist?

The FDA has approved numerous antiretroviral therapies (ART) for the treatment of HIV/AIDS, which are the mainstay of managing the disease. These include nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transfer inhibitors (INSTIs), and entry inhibitors. While monoclonal antibodies and immune checkpoint inhibitors are more commonly associated with cancer treatment, their application in HIV is still investigational. Budigalimab, a monoclonal antibody targeting an immune checkpoint, and ABBV-382 are currently being studied for their potential in HIV treatment, representing a novel approach in the ongoing effort to manage and potentially cure HIV/AIDS.

What other types of research exist?

Promising novel alternatives for HIV/AIDS treatment in 2024 include: 1) Lenacapavir, a long-acting capsid inhibitor with potential for both treatment and prevention of HIV. 2) Islatravir, a nucleoside reverse transcriptase translocation inhibitor (NRTTI) with a long half-life, allowing for less frequent dosing. 3) Broadly neutralizing antibodies (bNAbs) like VRC01, which target multiple strains of HIV and are being explored for both treatment and prevention. 4) Gene editing technologies such as CRISPR, which are being investigated for their potential to provide a functional cure by targeting and excising HIV DNA from infected cells.

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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 112 weeks

Summary

This trial is testing two new drugs, Budigalimab and ABBV-382, to treat HIV. It involves adults with stable HIV who will pause their usual treatment. The goal is to see if these new drugs can control the virus better.

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.

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.

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.

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My CD4+ T cell count has been above 500 for the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 112 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 112 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 112 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Adverse Events (AEs)

Percentage of Participants with Viral Control Without Antiretroviral Therapy (ART) Restart

Secondary study objectives

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

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm F: Budigalimab Dose BExperimental Treatment1 Intervention

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).

Group II: Arm E: Budigalimab Dose A + ABBV-382 Dose AExperimental Treatment2 Interventions

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.

Group III: Arm D: Budigalimab Dose A + ABBV-382 Dose BExperimental Treatment2 Interventions

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.

Group IV: 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 V: Arm B: Budigalimab Dose AExperimental Treatment2 Interventions

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.

Group VI: 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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for HIV/AIDS primarily involve antiretroviral therapy (ART), which includes drugs that inhibit various stages of the HIV life cycle, such as reverse transcriptase inhibitors, protease inhibitors, and integrase inhibitors. These drugs work by preventing the virus from replicating, thereby reducing viral load and improving immune function. Budigalimab, a monoclonal antibody targeting an immune checkpoint, works by modulating the immune response to enhance the body's ability to fight HIV. ABBV-382, another investigational drug, is being studied for its potential to further control HIV. These treatments are crucial for HIV/AIDS patients as they help manage the disease, reduce the risk of opportunistic infections, and improve overall quality of life.

CROI 2016: Advances in Antiretroviral Therapy.Rapid urine-based screening for tuberculosis in HIV-positive patients admitted to hospital in Africa (STAMP): a pragmatic, multicentre, parallel-group, double-blind, randomised controlled trial.Lessons learned from HIV treatment interruption: safety, correlates of immune control, and drug sparing.