What side effects are associated with this type of intervention?

Common side effects of HIV treatments, particularly monoclonal antibodies like TMB-365 and TMB-380, include infusion-related reactions such as fever, chills, rash, and low blood pressure. Other common HIV treatments, such as protease inhibitors and combination therapies like lamivudine-zidovudine, often cause nausea, fatigue, and gastrointestinal issues. Serious side effects are less frequent but can include liver toxicity and hypersensitivity reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for HIV, including antiretroviral therapies (ART) that target various stages of the HIV life cycle. While specific monoclonal antibodies like TMB-365 and TMB-380, which target the CD4 receptor and HIV to prevent viral entry, are still under investigation, other monoclonal antibodies such as ibalizumab-uiyk have been approved. Ibalizumab-uiyk is a post-attachment inhibitor that binds to the CD4 receptor, preventing HIV from entering host cells. This approval represents a significant step in the use of monoclonal antibodies for HIV treatment, complementing the broader range of ART options available.

What other types of research exist?

Promising novel alternatives for HIV treatment in 2024 include: 1) Long-acting injectable antiretrovirals such as cabotegravir and rilpivirine, which offer the convenience of less frequent dosing. 2) Broadly neutralizing antibodies (bNAbs) like VRC01, which target multiple sites on the HIV envelope protein, potentially offering a new approach to both treatment and prevention. 3) Lenacapavir, a capsid inhibitor with a novel mechanism of action, showing promise in clinical trials for its long-acting potential. These alternatives provide new mechanisms of action and improved adherence options for HIV patients.

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Monoclonal Antibodies

TMB-365 + TMB-380 for HIV

Phase 1 & 2

Waitlist Available

Led By Jay Lalezari, MD

Research Sponsored by TaiMed Biologics Inc.

Eligibility Criteria Checklist

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

Must have

Male or female at least 18 years of age and no greater than 60 years on the day of Screening.

Females of childbearing potential, sexually active with a male sex partner, must agree to use one effective method of contraception from the time of signing the consent to completion of the study, and agree to pregnancy testing as per the Schedule of Events and Procedures. Females of childbearing potential are female participants who are not surgically sterile (no history of bilateral tubal ligation, hysterectomy, or bilateral salpingo-oophorectomy), are not postmenopausal (at least one year without menses), and are not otherwise sterile by medical evaluation

Must not have

Suppressed subjects receiving cabotegravir and rilpivirine intramuscularly as maintenance therapy for HIV-1 infection

Major psychiatric illness including any history of schizophrenia or severe psychosis, uncontrolled bipolar disorder requiring acute therapy, or suicide attempt in the previous three years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 weeks

Awards & highlights

Summary

This trial tests two special proteins, TMB-365 and TMB-380, in people with HIV who are already managing their condition with regular medication. The proteins work by blocking the virus from entering cells and attaching directly to it. The goal is to see if these proteins can maintain control of HIV without regular medication.

Who is the study for?

Adults aged 18-60 with asymptomatic HIV-1, on stable cART for at least 6 months without interruption, and have undetectable viral loads. They must have a CD4+ T cell count over 350 cells/mm3 and meet certain lab value criteria. Women of childbearing potential must agree to use contraception and undergo pregnancy tests.

What is being tested?

The trial is testing the safety and how the body processes different doses of two monoclonal antibodies, TMB-365 and TMB-380 (VRC-07-523LS), in individuals with suppressed HIV who are on cART. The goal is to find optimal dosing for these drugs as maintenance therapy without oral cART for 24 weeks.

What are the potential side effects?

Potential side effects may include allergic reactions due to sensitivity to components in the study drugs or other monoclonal antibodies, infusion-related reactions, immune system changes, or exacerbation of underlying conditions like allergies or asthma.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

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I agree to use birth control and undergo pregnancy tests if I can still have children.

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I have HIV but do not show symptoms, confirmed by tests.

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I have HIV but do not show symptoms, confirmed by tests.

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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on maintenance therapy for HIV with cabotegravir and rilpivirine injections.

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I do not have a history of severe mental health issues like schizophrenia, uncontrolled bipolar disorder, or recent suicide attempts.

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I have difficulty with IV lines due to poor vein access.

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I haven't been hospitalized or needed treatment for a serious illness in the last 3 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 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

Antiviral activity of the combination of TMB-365 in combination with TMB-380 as maintenance therapy in suppressed HIV infected individuals.

Pharmacokinetics of TMB-365 and TMB-380 given intravenously every 8 weeks or 12 weeks

Safety of TMB-365 and TMB-380 given intravenously every 8 weeks or 12 weeks

Other study objectives

Immunogenicity of TMB-365 and TMB-380 infusions

Resistance to TMB-365 and TMB-380

Trial Design

4Treatment groups

Experimental Treatment

Group I: Sentinel Group 3Experimental Treatment1 Intervention

10 HIV-1 infected subjects will receive one infusion of 4800 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.

Group II: Sentinel Group 2Experimental Treatment1 Intervention

10 HIV-1 infected subjects will receive one infusion of 3200 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.

Group III: Sentinel Group 1Experimental Treatment1 Intervention

10 HIV-1 infected subjects will receive one infusion of 2400 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.

Group IV: Core Group 1Experimental Treatment1 Intervention

20 HIV-1 infected subjects will receive 4800 mg infusions of each antibody, TMB-365 and TMB-380 every 8 weeks and be followed for safety, pharmacokinetics, and ability to maintain antiviral activity. Oral suppressive cART will be discontinued for 24 weeks then resumed at week 24 with follow-up at week 52.

0 / 9Eligibility 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

Monoclonal antibodies like TMB-365 and TMB-380 work by interfering with HIV entry into host cells. TMB-365 targets the CD4 receptor on host cells, and TMB-380 binds directly to the HIV virus. This dual mechanism prevents the virus from attaching to and entering the host cells, thereby inhibiting its replication. This approach is significant for HIV patients as it offers a potential alternative to daily oral antiretroviral therapy, which can improve treatment adherence and reduce side effects.