What side effects are associated with this type of intervention?

Broadly neutralizing antibodies (bNAbs) such as Teropavimab and Zinlirvimab, and the capsid inhibitor Lenacapavir, are being studied for their effectiveness in treating HIV. Common side effects of bNAbs can include infusion-related reactions such as fever, chills, and rash. Lenacapavir, as a capsid inhibitor, may cause gastrointestinal issues, injection site reactions, and potential liver enzyme elevations. General side effects of antiretroviral therapies (ART) include headache, fatigue, nausea, and potential long-term effects like lipid abnormalities and insulin resistance.

What prior FDA approvals exist?

The FDA has approved several antiretroviral drugs for the treatment of HIV infection, including various classes such as nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transfer inhibitors (INSTIs), and entry inhibitors. Broadly neutralizing antibodies (bNAbs) like teropavimab and zinlirvimab are a newer approach under investigation, aiming to target multiple strains of HIV. Lenacapavir, a capsid inhibitor, represents another innovative treatment strategy by interfering with the HIV capsid, a protein shell essential for viral replication. These novel therapies are part of ongoing research to improve efficacy and tolerability in virologically suppressed adults with HIV-1 infection.

What other types of research exist?

Promising alternatives to the combination of teropavimab, zinlirvimab, and lenacapavir for HIV treatment in 2024 include the use of other broadly neutralizing antibodies such as VRC01 and 3BNC117, which have shown potential in clinical trials. Additionally, long-acting injectable antiretrovirals like cabotegravir and rilpivirine, as well as new classes of drugs like maturation inhibitors and attachment inhibitors, are being explored as effective treatment options for HIV patients.

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Capsid Inhibitor

Combination Antiretroviral Therapy for HIV

Q: What is the mechanism of action of this treatment?

Broadly neutralizing antibodies (bNAbs) like Teropavimab and Zinlirvimab target multiple sites on the HIV virus, preventing it from entering and infecting host cells. Capsid inhibitors like Lenacapavir disrupt the HIV capsid, which is essential for viral replication and assembly. These mechanisms are crucial for HIV patients as they offer a targeted approach to suppress the virus, potentially reducing the need for daily medication and improving adherence and outcomes.

Phase 2

Waitlist Available

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first dose date up to end of study (up to approximately 6 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new combination treatment for adults with HIV-1 who are already keeping the virus under control. The treatment uses special proteins to block the virus and a new medication to stop it from making more copies. Researchers want to see if this new approach works better than current treatments.

Who is the study for?

This trial is for adults with HIV-1 who've had a stable viral load under 50 copies/mL for at least a year, no significant resistance to their current ART regimen, and CD4+ T-cell count over 200 cells/μL. They shouldn't have hepatitis B or C infections, require ongoing immunosuppression, or have had Stage 3 HIV illnesses.

What is being tested?

The study tests the effectiveness of switching from standard oral ART to a new regimen combining lenacapavir (LEN) with two antibodies, teropavimab and zinlirvimab. It measures if participants maintain low HIV RNA levels (<50 copies/mL) after this switch.

What are the potential side effects?

Potential side effects may include reactions at injection sites for LEN and infusion-related reactions for bNAbs. Other common side effects can be fatigue, headache, gastrointestinal issues like nausea or diarrhea, and possible changes in liver enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose date up to end of study (up to approximately 6 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose date up to end of study (up to approximately 6 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose date up to end of study (up to approximately 6 years) for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

PK Parameter: AUClast for GS-5423, GS-2872, and LEN

PK Parameter: Cmax for GS-5423, GS-2872, and LEN

PK Parameter: Tmax for GS-5423, GS-2872, and LEN

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Randomized Phase: Lenacapavir (LEN) + Teropavimab Dose A + Zinlirvimab Dose BExperimental Treatment4 Interventions

Participants will receive oral LEN 600mg, subcutaneous (SC) LEN 927 mg, teropavimab Dose A, and zinlirvimab Dose B on Day 1. Participants will self-administer oral LEN 600 mg on Day 2. The last treatment regimen will include SC LEN + teropavimab Dose A + zinlirvimab Dose B.

Group II: Randomized Phase: Antiretroviral Therapy (ART)Experimental Treatment1 Intervention

Participants will continue their baseline oral ART through Week 52.

Group III: Extension Phase: LEN + Teropavimab Dose A + Zinlirvimab Dose BExperimental Treatment3 Interventions

At Week 52, participants who receive the study drug of LEN, teropavimab, zinlirvimab, and complete study through Week 52 with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \< 50 copies/mL will be given the option to participate in the study extension phase, where they will continue to receive their randomized study drugs treatment regimen until after completion of the primary analysis (unless modified based on the data monitoring committee (DMC) analysis), up to approximately 5 years.

Group IV: Extension Phase: ARTExperimental Treatment4 Interventions

Participants who complete study through Week 52 with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound (VR) throughout the randomized phase of the study will be given the option to participate in the extension phase and receive the study drugs of LEN, teropavimab, and zinlirvimab at the dose specified for randomized phase until after completion of the primary analysis (unless modified based on the data monitoring committee (DMC) analysis), up to approximately 5 years. Treatment with study drug will begin at Week 52 and at that time the baseline oral ART will be discontinued.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Teropavimab

2021

Completed Phase 1

~40

Zinlirvimab

2021

Completed Phase 1

~40

Antiretroviral Therapy

2016

Completed Phase 2

~240

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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

Broadly neutralizing antibodies (bNAbs) like Teropavimab and Zinlirvimab target multiple sites on the HIV virus, preventing it from entering and infecting host cells. Capsid inhibitors like Lenacapavir disrupt the HIV capsid, which is essential for viral replication and assembly. These mechanisms are crucial for HIV patients as they offer a targeted approach to suppress the virus, potentially reducing the need for daily medication and improving adherence and outcomes.

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