What side effects are associated with this type of intervention?

Common treatments for HIV, such as antiretroviral therapy (ART), can cause side effects including gastrointestinal issues, fatigue, and metabolic changes like lipodystrophy. Gene editing treatments, like CRISPR-Cas9 studied in the EBT-101 trial, are still in early research stages. Preliminary data suggest mild adverse effects, such as transient immune responses, with no serious off-target effects reported.

What prior FDA approvals exist?

The FDA has approved various antiretroviral therapies (ART) for the treatment of HIV, including integrase strand transfer inhibitors (InSTIs) and drugs targeting the CCR5 receptor. While investigational approaches like CRISPR-Cas9 gene editing, as seen in the EBT-101 trial, are being explored to excise HIV-1 proviral DNA, specific FDA approvals for CRISPR-Cas9 in HIV treatment have not been detailed. Current ART regimens remain the cornerstone of HIV management.

What other types of research exist?

Promising alternatives to EBT-101 for HIV treatment include: 1) Long-acting injectable antiretrovirals, which provide sustained drug release and reduce the frequency of dosing. 2) Broadly neutralizing antibodies (bNAbs) that target multiple HIV strains and can be used for both treatment and prevention. 3) Therapeutic vaccines aimed at enhancing the immune response against HIV. 4) RNA interference (RNAi) therapies that target and degrade HIV RNA, reducing viral replication. 5) Latency-reversing agents (LRAs) combined with antiretroviral therapy to target and eliminate latent HIV reservoirs.

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Virus Therapy

Long-Term Follow-Up of 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

Study Summary

This trial is for people who have taken EBT-101 before and are willing to be monitored for long-term effects.

Who is the study for?

This trial is for adults with HIV who have previously received the investigational treatment EBT-101 in an earlier study. They must have signed a consent form agreeing to participate and be monitored over time.Check my eligibility

What is being tested?

The focus of this study is on long-term follow-up of patients who were treated with EBT-101, which is a new intervention for HIV. The goal is to observe the extended effects and outcomes after initial treatment.See study design

What are the potential side effects?

Since this is a follow-up study, specific side effects are not listed here. However, it will monitor any long-term side effects from the previous use of EBT-101 in participants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Long-term safety of EBT-101

Trial Design

1Treatment groups

Experimental Treatment

Group I: Long Term Follow UpExperimental Treatment1 Intervention

Participants who received EBT-101 in a parent study will undergo long term follow up

Do I qualify?Apply below to find out

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 therapy (ART) and integrase strand transfer inhibitors (InSTIs). ART works by using a combination of drugs to suppress the HIV virus, preventing it from replicating and reducing the viral load in the body. InSTIs specifically inhibit the integrase enzyme, which is crucial for the integration of viral DNA into the host genome. Gene editing approaches, such as CRISPR-Cas9, offer a novel mechanism by directly excising HIV-1 proviral DNA from the host genome, potentially providing a functional cure. This matters for HIV patients as it could lead to long-term remission without the need for continuous medication, significantly improving quality of life and reducing the risk of drug resistance.

Advances in antiretroviral therapy.[Resistance to antiretroviral therapy].

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Who is running the clinical trial?

Excision BioTherapeuticsLead Sponsor

1 Previous Clinical Trials

6 Total Patients Enrolled

William Kennedy, MDStudy DirectorExcision BioTherapeutics

1 Previous Clinical Trials

6 Total Patients Enrolled

Study DirectorStudy DirectorExcision BioTherapeutics

1,221 Previous Clinical Trials

499,965 Total Patients Enrolled

Media Library

EBT-101 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05143307 — Phase 1

HIV Research Study Groups: Long Term Follow Up

HIV Clinical Trial 2023: EBT-101 Highlights & Side Effects. Trial Name: NCT05143307 — Phase 1

EBT-101 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05143307 — Phase 1

HIV Patient Testimony for trial: Trial Name: NCT05143307 — Phase 1

~6 spots leftby Jan 2037

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