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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
Study Summary
This trial will test a new drug, EBT-101, on people with HIV who are taking antiretroviral therapy.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and Tolerability of EBT-101
Trial Design
3Treatment groups
Experimental Treatment
Group I: EBT-101 Dose-Level 3Experimental Treatment1 Intervention
Cohort C: Participants will be administered dose-level 3 of EBT-101
Group II: EBT-101 Dose-Level 2Experimental Treatment1 Intervention
Cohort B: Participants will be administered dose-level 2 of EBT-101
Group III: EBT-101 Dose-Level 1Experimental Treatment1 Intervention
Cohort A: Participants will be administered dose-level 1 of EBT-101
Find a Location
Who is running the clinical trial?
Excision BioTherapeuticsLead Sponsor
1 Previous Clinical Trials
9 Total Patients Enrolled
Study DirectorStudy DirectorExcision BioTherapeutics
1,211 Previous Clinical Trials
489,500 Total Patients Enrolled
William Kennedy, MDStudy DirectorExcision BioTherapeutics
1 Previous Clinical Trials
9 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 60 years old.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 have been diagnosed with liver cirrhosis.I have had HIV-related memory or thinking problems.I have kidney problems due to HIV.I am a male by birth.I've changed my HIV treatment due to failure at least once in the last 2 years.I have never received any gene therapy products.I have been vaccinated against N. meningitidis.My CD4 T cell count has been 500 or more for the last 2 years.I have been on a stable HIV treatment for over 2 years without major changes.I have been diagnosed with a severe form of fatty liver disease not caused by alcohol.I have had an AIDS-related infection before screening.I am a male by birth.I have been on a stable HIV treatment for over a year with undetectable viral levels.My HIV has shown resistance to two or more types of treatment in the last 5 years.I have been on a stable HIV treatment for over 2 years with undetectable viral load.I have had progressive multifocal leukoencephalopathy in the past.I have had serious heart problems in the last 2 years.I have chronic HIV-1 subtype B.I am willing to pause my HIV treatment for a study.I have been on or am planned to be on long-acting injectable ART in the last year.I am between 18 and 70 years old.My weight is between 45 and 90 kg.You are willing to enroll in the study and sign the informed consent.
Research Study Groups:
This trial has the following groups:- Group 1: EBT-101 Dose-Level 1
- Group 2: EBT-101 Dose-Level 2
- Group 3: EBT-101 Dose-Level 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is this clinical trial being implemented in medical facilities across North America?
"Presently, this experiment is going on at 7 locations around the USA, including Saint Louis, Camden and Orlando. It is recommended to choose a site closest to you in order to lessen travel burdens should you decide to join."
Answered by AI
How extensive is the patient cohort in this research effort?
"Affirmative, the clinicaltrials.gov database states that this medical trial is still recruiting patients. It has been live since January 24th 2022 and was recently modified on October 17th 2022. Recruitment of 9 individuals from 7 sites is needed to complete the study's requirements."
Answered by AI
What is the regulatory status of EBT-101?
"Due to the limited data available, our team at Power rated EBT-101's safety as a 1 on a scale from 1 to 3. This is because this trial is in its preliminary stage, so only basic information about efficacy and safety are known."
Answered by AI
Is enrollment open into this research endeavor at the present time?
"According to clinicaltrials.gov, this experimental trial is currently enrolling patients. The listing was first published on January 24th 2022 and the description of the study has been modified as recently as October 17th 2022."
Answered by AI
Are octogenarians being included in the recruitment for this research project?
"All participants must be over 18 and beneath 65 years of age in order to qualify for this research."
Answered by AI
What criteria must a person fulfill to be eligible to participate in this exploration?
"To be eligible for the trial, participants must have HIV-1 and be between 18 to 65 years old. Currently 9 patients are needed to complete the study."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
Washington University
Clinical Trial Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have been managing my HIV infection since 1992. At that time it was a death sentence and I watched many people die from AIDs but I am a survivor and I don't let this disease control my life. I have been on HIV medicine since 1994 and have always been faithful about taking care of my body, taking my medicine, eating right and exercising. I stay active in my free time by helping others online with my knowledge and experience. I have been in a stable relationship for 26 years with a negative partner and I am proud parent of two children and four grand children. I take care of my body and work full time. I feel now after so many years of a life with this disease that it is finally time to put this disease behind me. I am ready to take the next step to show the world that together we can beat this illness.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Can you schedule my visits on Wednesdays and Thursdays?
PatientReceived 2+ prior treatments
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