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Study of EBT-101 in Aviremic HIV-1 Infected Adults on Stable ART | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study of EBT-101 in Aviremic HIV-1 Infected Adults on Stable ART

A Phase 1/2a, Sequential Cohort, Single Ascending Dose Study of the Safety, Tolerability, Biodistribution, and Pharmacodynamics of EBT 101 in Aviremic HIV-1 Infected Adults on Stable Antiretroviral Therapy

NCT05144386•Excision BioTherapeutics

View on ClinicalTrials.gov

Summary

This is a First in Human (FIH) study of EBT-101 administered IV to aviremic HIV-1 infected adults on stable antiretroviral therapy (ART).

Detailed Description

This is a FIH, open-label, sequential cohort, single ascending dose (SAD) study of EBT-101 administered IV to aviremic HIV-1 infected adults on stable ART. Participants will be asked to attend several visits for screening to determine eligibility. On Day 1, eligible participants will receive a single IV dose of EBT-101. All participants will be assessed for eligibility for an analytical treatment interruption (ATI) of their background ART at Week 12. All participants will be followed through Week 48 (end of study). Participants are required to attend multiple study visits at the clinical site including daily visits for the first 14 days, followed by weekly visits after Week 12 for ATI participants. Non-ATI participants are followed monthly after Week 12. Eligible participants who are enrolled in the FIH study (EBT-101-001) will also be enrolled in a separate Long Term Follow Up (LTFU) study (EBT-101-002) for safety monitoring. The duration of the LTFU study is 15 years.

Eligibility

Age

18 - 70 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Willing to enroll and sign the written informed consent for EBT-101-001 (current study) and EBT-101-002, the LTFU study.
•Age between 18 and 70 years (both inclusive).
•Weight: Cohort A ≥55 and ≤110 kg, Cohort B ≥55 and ≤90 kg.
•Cohorts A and B will only enroll male subjects (sex at birth).
•Chronic HIV-1 with known subtype B infection
•On stable regimen defined as continuous ART suppressive treatment with HIV RNA level below the level of quantitation for \>1 years prior to screening
•Plasma HIV-1 RNA levels below the limit of quantitation during screening.
•Peripheral blood CD4 T cell count ≥500 cells/mm3 for at least 2 years prior to screening
•Willing and able to comply, as assessed by the Investigator, with all study-related procedures.
•Have previously been vaccinated for N. meningitidis with documented history and/or received a N. meningitidis vaccination prior to dosing.
+3 more criteria

Exclusion Criteria

•Documented prior HIV-1 drug resistance to ≥2 or more classes of ART defined as single key mutations or an accumulation of minor mutations that result in resistance to entire respective drug classes within the past 5 years.
•History of \>1 change in ART due to virologic failure during preceding 2 years prior to screening.
•Received in the preceding 12 months or HCP plans to prescribe long-acting injectable ART.
•History of HIV dementia.
•History of progressive multifocal leukoencephalopathy.
•History of significant cardiac disease in last 2 years.
•History of HIV-related kidney disease with abnormal renal function.
•Known history and/or documented: pre-HIV treatment nadir CD4+ T cell count \<200 cells/mm3 or post-suppressive HIV treatment confirmed CD4+ T cell \<200 cells/mm3 prior to screening
•History of AIDS-defining opportunistic infection prior to screening.
•Evidence of acute or chronic hepatitis B and/or hepatitis C.
+8 more criteria

Locations (3)

Quest Clinical Research

San Francisco, California, United States

Washington University

St Louis, Missouri, United States

Cooper Health

Camden, New Jersey, United States

Key Dates

Start Date

January 24, 2022

Primary Completion Date

November 14, 2024

Completion Date

November 14, 2024

Last Updated

December 2, 2024

Enrollment

ACTUAL participants

Conditions

HIV-1-infection

Interventions

EBT-101

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of EBT-101 in Aviremic HIV-1 Infected Adults on Stable ART

Inclusion Criteria

Exclusion Criteria

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