Clinical Trials Logo
  1. Home
  2. HIV-1 Infection
  3. NCT05143307
  4. Details
NCT05143307 Clinical Trial

Long-Term Follow-Up Study of HIV-1 Infected Adults Who Received EBT-101

HIV-1-infection Clinical Trial

Official title:
Long-Term Follow-Up Study of HIV-1 Infected Adults Exiting a Parent Study Where EBT-101 Was Administered

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05143307
Other study ID # EBT-101-002
Secondary ID
Status Enrolling by invitation
Phase Phase 1
First received
Last updated
Start date July 11, 2023
Est. completion date April 2037

Study information
Verified date November 2023
Source Excision BioTherapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Participants who receive EBT-101 in a parent protocol will be eligible to participate in this long-term follow-up (LTFU) study (EBT-101-002).

Description:

Participants who receive EBT-101 in a parent protocol will be eligible to participate in this LTFU study (EBT-101-002). All participants will have follow-up visits every six months until Year 5 post EBT-101. Thereafter, all participants will have follow-up visits annually on the anniversary of EBT-101 administration until study completion at Year 15.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 9
Est. completion date April 2037
Est. primary completion date January 2037
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Willing and able to provide written, signed informed consent - Participants who received the investigational study intervention EBT-101 in a parent study Exclusion Criteria: • Participants who did not receive EBT-101 in a parent study

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• EBT-101
Long term follow up of participants who received EBT-101

Locations
Country Name City State
United States Cooper Health Camden New Jersey
United States Washington University Saint Louis Missouri
United States Quest Clinical Research San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Excision BioTherapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Long-term safety of EBT-101 Long-term safety of EBT-101 will be assessed based on incidence and severity of clinically significant adverse events (AEs) according to Division of AIDS (DAIDS) 2017 over 15 years 15 years
See also
  Status Clinical Trial Phase
Recruiting NCT03940521 - Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment
Completed NCT03227731 - Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women Phase 2/Phase 3
Completed NCT03570918 - MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy Phase 1
Not yet recruiting NCT06336434 - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy Phase 1/Phase 2
Active, not recruiting NCT04022967 - ANRS 12372 MODERATO Study Phase 3
Not yet recruiting NCT06282783 - Studying Topiramate for Re-Activating the HIV-1 Reservoir Phase 1/Phase 2
Not yet recruiting NCT06337032 - A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments Phase 4
Completed NCT04711265 - Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys
Recruiting NCT03536234 - Efficacy and Safety of GnRH Analogue Triptorelin for HIV-1 Reservoir Reduction in ART Treated HIV-1 Infected Patients Phase 2
Completed NCT04340388 - Contribution of Dolutegravir to Obesity and Cardiovascular Disease Phase 4
Withdrawn NCT05769569 - Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission Phase 1
Enrolling by invitation NCT05584397 - Comparing Immune Activation and Latent HIV Reservoir Size Between People Living With HIV on Tenofovir-containing Versus NRTI-free ART
Completed NCT04963712 - Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder Early Phase 1
Completed NCT04388904 - Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza® in HIV-1 Infected Treatment-Experienced Patients Off Therapy. (ReSTART) Phase 4
Not yet recruiting NCT04894357 - Impact of V106I on Resistance to Doravirine
Not yet recruiting NCT04311957 - Continuation of Protease-Inhibitor Based Second-Line Therapy vs. Switch to B/F/TAF in Virologically Suppressed Adults Phase 4
Not yet recruiting NCT04311944 - Early Fast-Track Versus Standard Care for Persons With HIV Initiating TLD N/A
Not yet recruiting NCT04513496 - Telemedicine in HIV Care in Buenos Aires
Completed NCT04568239 - Impact of M184V on the Virological Efficacy to 3TC/DTG (LAMRES)
Completed NCT03998176 - Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE Phase 4