3BNC117 and 10-1074 in ART-treated Individuals
NCT03526848 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2025-10-01
Summary
The proposed study is a phase 1, open label, randomized study to evaluate the safety and antiretroviral activity of seven infusions of 3BNC117 and 10-1074, administered intravenously at 30 mg/kg dose level, in human immunodeficiency virus (HIV)-infected individuals on combination antiretroviral therapy (ART) and during an analytical interruption of ART.
Conditions
- Human Immunodeficiency Virus
Interventions
- DRUG
-
3BNC117
Intravenous infusion of 3BNC117
- DRUG
-
10-1074
Intravenous infusion of 3BNC117
- OTHER
-
Analytical treatment interruption
Analytical treatment interruption
Sponsors & Collaborators
-
National Institute of Allergy and Infectious Diseases (NIAID)
collaborator NIH -
Ragon Institute of MGH, MIT and Harvard
collaborator OTHER -
Montefiore Medical Center
collaborator OTHER -
Rockefeller University
lead OTHER
Principal Investigators
-
Marina Caskey, MD · The Rockefeller University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-06-05
- Primary Completion
- 2021-09-30
- Completion
- 2022-02-11
- FDA Drug
- Yes
Countries
- United States
Study Locations
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