What side effects are associated with this type of intervention?

Common treatments for HIV, such as antiretroviral therapy (ART), can cause a range of side effects including gastrointestinal issues, liver toxicity, metabolic complications, and cardiovascular problems. Gene-editing therapies like EBT-101, which are still experimental, may pose risks such as off-target genetic modifications and immune reactions. Patients should discuss these potential side effects with their healthcare provider to make informed decisions about their treatment options.

What prior FDA approvals exist?

The FDA has approved various treatments for HIV, primarily focusing on antiretroviral therapies (ART) that inhibit the virus's replication. 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 traditional ARTs have been the mainstay of HIV treatment, gene-editing therapies like EBT-101, which aim to target and potentially eradicate HIV-1 at the genetic level, represent a novel approach. As of now, there are no FDA-approved gene-editing therapies for HIV, but ongoing research and clinical trials, such as those involving CRISPR technology, are exploring this promising avenue.

What other types of research exist?

Promising novel alternatives to EBT-101 for HIV patients include: 1) Long-acting injectable antiretrovirals like cabotegravir and rilpivirine, which offer less frequent dosing schedules. 2) Broadly neutralizing antibodies (bNAbs) that target multiple HIV strains and can be used for both treatment and prevention. 3) Other gene-editing therapies such as CRISPR-Cas9 targeting HIV proviral DNA. 4) Therapeutic vaccines aimed at enhancing the immune response against HIV. These alternatives are in various stages of clinical development and offer potential benefits in terms of efficacy, convenience, and reduced side effects.

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Virus Therapy

EBT-101 for HIV

Phase 1

Waitlist Available

Research Sponsored by Excision BioTherapeutics

Eligibility Criteria Checklist

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

Must have

Body weight ≥55 and ≤110 kg

Must have received a COVID-19 vaccination series and boosters as specified by current federal (CDC) recommendations, with the last dose ≥30 days prior to dosing

Must not have

Diagnosis of nonalcoholic fatty liver or advanced nonalcoholic steatohepatitis

Known history or diagnosis of liver cirrhosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests EBT-101, a new treatment given through a vein, in adults with HIV who have undetectable virus levels. The goal is to see if EBT-101 can help eliminate the virus, potentially allowing patients to stop their regular medication.

Who is the study for?

This trial is for aviremic HIV-1 infected males, aged 18-60, on stable ART for over 2 years with no breaks or changes in the last year. Participants must have undetectable viral loads, CD4 counts >500 cells/mm3, be vaccinated against N. meningitidis and COVID-19, and willing to potentially stop ART.

What is being tested?

EBT-101 is being tested as a new treatment option for HIV. It's given intravenously to adults who are already on antiretroviral therapy (ART) that keeps their virus levels low. The study will monitor how well EBT-101 works and its safety.

What are the potential side effects?

As this is a first-in-human study of EBT-101, specific side effects are not yet known but may include typical reactions related to IV administration such as pain at the injection site, fever or chills.

Eligibility Criteria

Inclusion Criteria

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

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My weight is between 55 and 110 kg.

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I have completed the COVID-19 vaccination series and boosters as recommended, with the last dose taken at least 30 days ago.

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I have been vaccinated against N. meningitidis.

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My CD4 T cell count has been 500 or more for the last 2 years.

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I am a male by birth.

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I have chronic HIV-1 subtype B.

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I am willing to pause my HIV treatment for a study.

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I am between 18 and 70 years old.

Exclusion Criteria

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

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I have been diagnosed with a severe form of fatty liver disease not caused by alcohol.

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I have been diagnosed with liver cirrhosis.

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I have had HIV-related memory or thinking problems.

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I have kidney problems due to HIV.

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I've changed my HIV treatment due to failure at least once in the last 2 years.

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I have never received any gene therapy products.

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I have had an AIDS-related infection before screening.

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I have had progressive multifocal leukoencephalopathy in the past.

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I have had serious heart problems in the last 2 years.

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I have been on or am planned to be on long-acting injectable ART in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 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

Safety and Tolerability of EBT-101

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: EBT-101 Dose-Level 2Experimental Treatment1 Intervention

Cohort B: Participants will be administered dose-level 2 of EBT-101

Group II: EBT-101 Dose-Level 1Experimental Treatment1 Intervention

Cohort A: Participants will be administered dose-level 1 of EBT-101

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EBT-101

2022

Completed Phase 1

~10

0 / 18Eligibility 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 include antiretroviral drugs such as integrase strand transfer inhibitors (InSTIs), which prevent the integration of viral DNA into the host genome, and reverse transcriptase inhibitors (RTIs), which block the reverse transcription of viral RNA into DNA. Protease inhibitors (PIs) prevent the maturation of viral proteins, and entry inhibitors block the virus from entering host cells. These mechanisms are crucial as they reduce viral load, improve immune function, and prevent the progression to AIDS. Gene-editing therapies like EBT-101, which target and disrupt the HIV-1 genome, offer a potential for a functional cure by permanently inactivating the virus, representing a significant advancement over traditional therapies.

Modeling Favipiravir Antiviral Efficacy Against Emerging Viruses: From Animal Studies to Clinical Trials.New Antiretroviral Treatment for HIV.Advances in antiretroviral therapy.