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.

← Back to Search

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

Must not have

Participants who did not receive EBT-101 in a parent study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial involves follow-up for participants who received the EBT-101 treatment in an earlier study. The goal is to monitor their health and the treatment's effects over time.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

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

Select...

I have not previously received EBT-101 in any study.

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

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

Primary study objectives

Long-term safety of EBT-101

Awards & Highlights

No Placebo-Only Group

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

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

0 / 1Eligibility 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 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].