EBT-101 for HIV

Recruiting at 6 trial locations

Overseen By William Kennedy, MD

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Excision BioTherapeutics

Must be taking: Antiretrovirals

Must not be taking: Injectable ART

Disqualifiers: HIV dementia, Cardiac disease, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

6 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires participants to be on a stable antiretroviral therapy (ART) regimen before joining, and they must be willing to stop ART if eligible for a treatment interruption. The protocol does not specify stopping other medications.

What safety data exists for EBT-101 or similar treatments for HIV?

The available research discusses adverse events (unwanted side effects) related to antiretroviral treatments for HIV, but does not specifically mention EBT-101. These studies highlight that while antiretroviral treatments can be effective, they may also cause serious side effects, which vary by drug and patient characteristics. ^{1 2 3 4 5}

Research Team

William Kennedy, MD

Principal Investigator

Excision BioTherapeutics

Eligibility Criteria

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.

Inclusion Criteria

My weight is between 55 and 110 kg.

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

I am a male by birth.

Exclusion Criteria

I have been diagnosed with liver cirrhosis.

I have had HIV-related memory or thinking problems.

Evidence of acute or chronic hepatitis B and/or hepatitis C

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Several visits

Treatment

Participants receive a single IV dose of EBT-101 on Day 1

1 day

1 visit (in-person)

Initial Follow-up

Participants are monitored daily for the first 14 days post-treatment

2 weeks

Daily visits (in-person)

Analytical Treatment Interruption (ATI) Follow-up

Participants eligible for ATI are monitored weekly after Week 12

36 weeks

Weekly visits (in-person)

Non-ATI Follow-up

Non-ATI participants are followed monthly after Week 12

36 weeks

Monthly visits (in-person)

Long Term Follow Up (LTFU)

Participants are enrolled in a separate LTFU study for safety monitoring

15 years

Treatment Details

Interventions

• EBT-101

Trial Overview 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.

Participant Groups

Group I: EBT-101 Dose-Level 2 Experimental Treatment 1 Intervention

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

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

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

Who Is Running the Clinical Trial?

Excision BioTherapeutics

Lead Sponsor

Trials

2

Recruited

20+

Findings from Research

In a study of 1301 HIV-infected participants over a median follow-up of 5 years, significant differences in the risk of specific adverse events were observed based on gender and race, with black participants showing higher risks for cardiovascular and renal events, and women having a greater risk for anemia.

Despite these differences in specific adverse events, the overall rates of adverse events, all-cause mortality, and treatment discontinuations due to toxicity were similar across gender and racial groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethnicity, race, and gender. Differences in serious adverse events among participants in an antiretroviral initiation trial: results of CPCRA 058 (FIRST Study). Tedaldi, EM., Absalon, J., Thomas, AJ., et al.[2022]

In a study of 1160 patients on antiretroviral treatment for HIV-1, 47% experienced clinical adverse events and 27% had laboratory adverse events linked to their treatment, highlighting a significant prevalence of side effects.

The research found that more complex treatment regimens, such as dual-PI and three-class antiretroviral treatments, were associated with a higher likelihood of adverse events compared to simpler single-PI treatments, indicating the need for careful monitoring of patients on these regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of adverse events associated with potent antiretroviral treatment: Swiss HIV Cohort Study. Fellay, J., Boubaker, K., Ledergerber, B., et al.[2022]

The SCOLTA project has enrolled 1184 patients to monitor adverse reactions to new antiretroviral drugs, with a significant focus on lopinavir/ritonavir (LPV/r), which reported 73 out of 100 severe adverse events (grades III and IV).

The rate of adverse events in the LPV/r cohort was 14.2 per 100 person-years, indicating that this system provides valuable real-time data for assessing the safety and long-term toxicity of antiretroviral treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Italian approach to postmarketing monitoring: preliminary results from the SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals) project on the safety of lopinavir/ritonavir. Bonfanti, P., Martinelli, C., Ricci, E., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Ethnicity, race, and gender. Differences in serious adverse events among participants in an antiretroviral initiation trial: results of CPCRA 058 (FIRST Study). [2022]

2. England pubmed.ncbi.nlm.nih.gov

Prevalence of adverse events associated with potent antiretroviral treatment: Swiss HIV Cohort Study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A new era of antiretroviral drug toxicity. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

An Italian approach to postmarketing monitoring: preliminary results from the SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals) project on the safety of lopinavir/ritonavir. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Prevalence and Patterns of Adverse Drug Events Among Adult Patients with Human Immune Virus Infection on Dolutegravir-Based Antiretroviral Drug Regimens in Amhara Comprehensive Specialized Hospitals, Northwest Ethiopia: A Multicenter Retrospective Follow-Up Study. [2023]