HIV-1 Specific T -Cells (HST-NEETs) for HIV-Infected Individuals
NCT03485963 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2025-04-29
Summary
This is a phase I, multi-site, study of the safety, immunologic and virologic responses of ex vivo expanded HIV-1 multi-antigen specific T-cell therapy (HST-NEET) as a therapeutic strategy in HIV-infected individuals suppressed on antiretroviral therapy (ART).
Conditions
- HIV Infections
Interventions
- BIOLOGICAL
-
HST-NEETs
The primary objective of this study is to evaluate the safety and tolerability of expanded HIV-specific T cell therapy (HST-NEETs) in HIV-infected individuals suppressed on cART. Patients with a partial response or stable disease 8 weeks after T-cell infusion were eligible to receive additional T-cells, consisting of the same number of cells as their second injection.
Sponsors & Collaborators
-
Catherine Bollard
lead OTHER
Principal Investigators
-
Michael Keller, MD · CNMC
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-21
- Primary Completion
- 2021-09-15
- Completion
- 2022-06-21
- FDA Drug
- Yes
Countries
- United States
Study Locations
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