A Randomised Placebo Controlled Trial of ART Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs).
NCT04319367 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2024-04-17
Summary
RIO is a placebo-controlled double-blinded two arm prospective phase II randomised controlled trial . This study will test the use of broadly neutralising antibodies (bNAbs) in participants with treated primary HIV infection (PHI).
Conditions
- HIV/AIDS and Infections
Interventions
- DRUG
-
Investigational Medicinal Product
Recombinant human monoclonal antibody (mAb) or placebo
Sponsors & Collaborators
-
Bill and Melinda Gates Foundation
collaborator OTHER -
University of Oxford
collaborator OTHER -
Rockefeller University
collaborator OTHER -
Imperial College London
lead OTHER
Principal Investigators
-
Sarah Fidler, MBBS, Ph.D · Imperial College London
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-17
- Primary Completion
- 2027-07-31
- Completion
- 2027-07-31
Countries
- Denmark
- United Kingdom
Study Locations
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