RecruitingPhase 2NCT04319367

A Randomised Placebo Controlled Trial of ART Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs).

A Randomised Placebo Controlled Trial of ART Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs) vs ART Plus Placebo in Treated Primary or Early Stage HIV Infection on Viral Control Off ART


Sponsor

Imperial College London

Enrollment

72 participants

Start Date

May 17, 2021

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving two broadly neutralizing antibodies (bNAbs — laboratory-made proteins that can block HIV) along with standard HIV treatment (ART) can help people who were treated very early after HIV infection achieve long-term HIV control, potentially reducing reliance on daily pills. **You may be eligible if...** - You are between 18 and 60 years old - You started HIV treatment (ART) within 6 months of your estimated time of infection - You can provide evidence of recent HIV infection (such as a recent negative test followed by a positive test) - You are willing to attend regular follow-up visits and provide blood samples **You may NOT be eligible if...** - You started HIV treatment more than 6 months after estimated infection - You have a documented resistance to the antibodies being tested - You have significant other health conditions that would make participation unsafe - You are pregnant or planning to become pregnant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInvestigational Medicinal Product

Recombinant human monoclonal antibody (mAb) or placebo


Locations(12)

Aarhus University Hospital

Aarhus, Denmark

University Hospitals Sussex NHS Foundation Trust

Brighton, United Kingdom

Western General Hospital

Edinburgh, United Kingdom

Imperial College NHS Healthcare Trust

London, United Kingdom

Barts Health NHS Trust

London, United Kingdom

Chelsea And Westminster Hospital NHS Foundation Trust

London, United Kingdom

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Mortimer Market CNWL Hospital NHS Foundation Trust

London, United Kingdom

Royal Free London NHS Foundation Trust

London, United Kingdom

St Georges Hospital NHS Foundation Trust

London, United Kingdom

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Oxford University Hospitals

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04319367


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