At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Investigational Medicinal Product (drug)
- How long the study runs
- Study runs about 74 months (dates as stated)
- About the drug or intervention
- Investigational Medicinal Product — drug: Recombinant human monoclonal antibody (mAb) or placebo
- Patient visit burden
- Not specified by the sponsor
In plain English
This trial, run by Imperial College London, is testing whether two long-acting laboratory-made antibodies against HIV (called broadly neutralising antibodies, or bNAbs) can help people living with HIV when added to their standard HIV treatment (antiretroviral therapy, or ART). People who join are chosen at random (by chance) to receive either the antibodies or a placebo (a dummy infusion with no active medicine). The placebo-controlled design means neither the researchers nor participants choose which group they go into.
Who can take part
- Adults aged 18 to 60
- Able to give written informed consent, including agreeing to long-term follow-up
- Willing and able to attend visits and give blood samples
- Started HIV treatment within six months of when they were first estimated to have caught HIV, based on specific test results — or started treatment early in infection, have never had a CD4 count (a type of immune cell) below 500, and have had an undetectable HIV viral load for at least one year on stable treatment (one reading between 50 and 500 copies/mL in that time is allowed)
- No signs that the virus is insensitive to the two antibodies used (10-1074 or 3BNC117), based on a gene-sequencing test
- Negative tests for hepatitis B and hepatitis C
- No major other health conditions
- Lowest-ever CD4 count above 250 for those diagnosed with early (primary) HIV infection
- Current CD4 count above 500, or a CD4 to CD8 ratio above 1
- On certain types of standard HIV treatment (an integrase inhibitor or boosted protease inhibitor based regimen); if previously on a different type (an NNRTI), must have switched at least 4 weeks before joining
- Good enough haemoglobin (iron) levels in the blood (at least 12 g/dL for males, 11 g/dL for females)
- Weigh at least 50 kg
- Vaccinated against COVID-19 at least 4 weeks before joining
- If able to become pregnant, must use contraception (hormonal, a coil, or complete abstinence) from 2 weeks before the first infusion until 20 months after the last infusion
Who may not be able to
- Past heart disease such as heart attack, angina, or stroke
- Any current or past cancer, apart from certain skin cancers (squamous cell skin cancers are allowed)
- An ongoing infection or other health condition likely to cause problems during the trial, such as malabsorption syndromes or autoimmune disease
- Any reason they cannot take standard recommended HIV combination medicines
- Infection with HTLV-1 (another virus)
- A positive COVID-19 test within 72 hours before joining
- Being at high risk of severe COVID-19, as defined by NHS England guidance (per the participant's doctor)
- Current or planned treatment that suppresses the immune system (inhaled or skin steroid treatments are allowed)
- Taking part in another trial of an experimental medicine, or any study needing extra blood draws (observational studies are allowed)
- Past severe allergic reactions (anaphylaxis) or bad reactions to antibody infusions, or allergy to the trial antibodies or their ingredients
- Planned treatment with IV immunoglobulin or other monoclonal antibody treatments during the trial
- Certain abnormal blood test results at screening, including serious liver problems, raised liver enzymes (ALT over 5 times the normal limit), reduced kidney function (eGFR under 60), protein in the urine, or abnormal clotting (INR over 1.5)
- Physical examination findings that, in the researcher's view, should prevent joining
- Alcohol or drug use that, in the researcher's view, would stop the person following the study requirements
- Veins not suitable for the scheduled blood draws
- Concern that the person may not take precautions to prevent passing HIV to others during a treatment interruption period
- Pregnancy or breastfeeding
What taking part involves
- • Random assignment (by chance) to receive either two long-acting HIV-specific broadly neutralising antibodies (bNAbs) or a placebo (dummy infusion)
- • Receiving the study medicine or placebo by infusion (drip) into a vein
- • Continuing or adjusting standard HIV treatment (ART) — participants must be on an integrase inhibitor or boosted protease inhibitor based regimen
- • A period of treatment interruption is mentioned as part of the study; further details of what happens during it: Not stated — ask the trial team
Time commitment: Taking part involves attending scheduled visits, regular blood sampling, receiving infusions of the antibodies or placebo, and long-term follow-up; the total trial duration and number of visits: Not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 60 Years
- Who
- All
- Number of participants
- 72
- Started
- 2021-05-17
- Last checked
- 2024-04
Plain English Summary
What is this study?
- • Testing a new treatment for hiv/aids and infections
- • Phase2 - 72 participants
- • RIO is a placebo-controlled double-blinded two arm prospective phase II randomised controlled trial
Who can take part?
- • Ages 18 Years to 60 Years
- • Diagnosed with hiv/aids and infections
Where?
- • Brighton - University Hospitals Sussex NHS Foundation Trust
- • Edinburgh - Western General Hospital
- • London - Imperial College NHS Healthcare Trust
- • London - Barts Health NHS Trust
- • +7 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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).
More detail
This study proposes a trial of a novel combination of long-acting broadly neutralising antibodies in participants initiating ART early after HIV acquisition, during primary HIV infection (PHI). The aim of this study is to investigate the effect of dual long-acting versions of bNABs (3BNC117-LS and 10-1074-LS) in a randomised clinical trial powered to answer the question whether these bNAbs are effective at controlling HIV replication in the absence of ART. The study aims to enrol 72 individuals across multiple UK collaborating clinical centres. Participants will have been previously diagnosed with primary HIV-1 infection, will have started ART during early phase of Primary HIV infection, and who have remained on suppressive ART without interruption for at least 12 months. Study duration will vary by participant, depending on the time to viral rebound. The results from this trial will demonstrate whether or not the combination of two long-acting (LS) broadly neutralising antibodies, 3BNC117-LS and 10-1074-LS, will prevent HIV viral rebound after stopping antiretroviral therapy for an extended period of time in adults living with HIV who initiated ART during early HIV infection.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 60 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓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. Estimated time of primary...
- ✓The date of a positive p24 antigen result with or without a negative HIV antibody test depending on local laboratory...
Who cannot take part
- ✗Previous ischaemic heart disease (ST or non-ST myocardial infarction, Q3-risk \> 20, stable angina, unstable angina,...
- ✗Any current or past history of cancer, excluding squamous cell skin cancers
- ✗Concurrent opportunistic infection or other other health condition or other health condition likely to occur during the trial e.g....
- ✗Any safety concern to receipt of BHIVA recommended combination antiretrovirals
- ✗HTLV-1 co-infection
See the full criteria
Where Is This Study? (11 UK sites)
University Hospitals Sussex NHS Foundation Trust
Brighton, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
Imperial College NHS Healthcare Trust
London W2 1NY, 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
How to Get in Touch
Stephen Fletcher
Sponsor contactCONTACT
