Actively Recruiting
A Randomised Placebo Controlled Trial of ART Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs).
Led by Imperial College London · Updated on 2024-04-17
72
Participants Needed
12
Research Sites
323 weeks
Total Duration
On this page
Sponsors
I
Imperial College London
Lead Sponsor
B
Bill and Melinda Gates Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Randomised Placebo Controlled Trial of ART Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 60 years old at screening
- Able to give informed written consent including consent to long-term follow-up
- Willing and able to comply with visit schedule and provide blood sampling
- Started ART within a maximum of six months of estimated time of primary infection based on defined criteria
- OR started ART in early stage infection with nadir CD4 > 500 cells and stable on ART with suppressed undetectable HIV viral load for at least 1 year
- No evidence of viral insensitivity to either 10-1074 or 3BNC117 antibodies based on proviral sequencing
- Negative for HBV and HCV markers
- No significant co-morbidities
- Nadir CD4 > 250 cells/µL for those with confirmed PHI
- Current CD4 count > 500 cells/µL or CD4:CD8 ratio >1
- On integrase inhibitor or boosted protease inhibitor based regimen at randomisation, with prior NNRTI switched at least 4 weeks before randomisation
- Adequate haemoglobin (≥12 g/dL for males, ≥11 g/dL for females)
- Weight ≥50 kg
- Vaccinated against COVID-19 at least 4 weeks prior to enrolment
- Females capable of becoming pregnant must agree to use effective contraception or abstinence from two weeks before first infusion until 20 months after last infusion
You will not qualify if you...
- Previous ischemic heart disease or stroke
- Any current or past malignancy except squamous cell skin cancers
- Current opportunistic infection or significant comorbidity likely to occur during trial
- Contraindication to BHIVA recommended antiretrovirals
- HTLV-1 co-infection
- SARS-Cov-2 infection confirmed within 72 hours prior to randomisation
- High risk for severe COVID-19 disease as defined by physician
- Current or planned systemic immunosuppressive therapy (inhaled or topical corticosteroids allowed)
- Participation in other clinical trials requiring blood draws
- History of severe allergic reactions to antibody infusions or components
- Planned treatment with IV immunoglobulin or other monoclonal antibodies during trial
- Significant abnormal blood tests including moderate to severe liver impairment, ALT >5x ULN, eGFR <60, uPCR >30 mg/mmol, INR >1.5
- Organ dysfunction or abnormal physical exam findings precluding enrolment
- Active alcohol or substance use preventing adherence
- Insufficient venous access for blood draws
- Concerns about not taking precautions to prevent HIV transmission during treatment interruption
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 12 locations
1
Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
2
University Hospitals Sussex NHS Foundation Trust
Brighton, United Kingdom
Actively Recruiting
3
Western General Hospital
Edinburgh, United Kingdom
Actively Recruiting
4
Imperial College NHS Healthcare Trust
London, United Kingdom, W2 1NY
Actively Recruiting
5
Barts Health NHS Trust
London, United Kingdom
Actively Recruiting
6
Chelsea And Westminster Hospital NHS Foundation Trust
London, United Kingdom
Actively Recruiting
7
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Actively Recruiting
8
Mortimer Market CNWL Hospital NHS Foundation Trust
London, United Kingdom
Actively Recruiting
9
Royal Free London NHS Foundation Trust
London, United Kingdom
Actively Recruiting
10
St Georges Hospital NHS Foundation Trust
London, United Kingdom
Actively Recruiting
11
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Actively Recruiting
12
Oxford University Hospitals
Oxford, United Kingdom
Actively Recruiting
Research Team
S
Stephen Fletcher
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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