BridgeMD
RIO Trial
EU CTIS ID: 2024-514564-13-00
What this study is testing
To determine the efficacy of dual bNAb infusion of 10-1074-LS and 3BNC117-LS at sustaining virological control within 20 weeks following initial ATI compared with placebo infusion.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged ≥18 to ≤60 years old at screening
- Current CD4 count > 500 cells/μl or CD4: CD8 ratio >1.0
- On integrase inhibitor (INSTI) or boosted protease inhibitor (bPI) based regimen at time of randomisation, if previously on non-nucleoside reverse transcriptase inhibitor (NNRTI) has switched at least 4 weeks prior to randomisation
- Adequate haemoglobin (Hb≥12 g/dL for males, ≥11 g/dL for females)
- Weight ≥ 50kg
- Have been vaccinated against coronavirus (COVID-19), at least 4 weeks prior to enrolment
You likely can't join if
- Previous ischaemic heart disease (ST or non-ST myocardial infarction, Q3-risk > 20, stable angina, unstable angina, stroke)
- History of anaphylaxis or severe adverse reaction to antibody infusions, or hypersensitivity to 3BNC117-LS or 10-1074-LS or to any constituent products or excipients thereof
- Treatment with IV immunoglobulin or other monoclonal antibody treatments planned during the duration of the trial
- Clinically significant abnormal blood test results at screening including a. Moderate to severe hepatic impairment as defined by significant liver impairment with evidence of advanced fibrosis or cirrhosis with decompensation b. ALT >5 x ULN c. eGFR <60 d. uPCR >30 mg/mmol e. INR >1.5
- Physical examination findings: Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination and/or vital signs that the investigator believes is a preclusion from enrolment into the study
- Active alcohol or substance use that, in the Investigator’s opinion, will prevent adequate adherence with study requirements
See the full eligibility criteria
Who can join
- Aged ≥18 to ≤60 years old at screening
- Current CD4 count > 500 cells/μl or CD4: CD8 ratio >1.0
- On integrase inhibitor (INSTI) or boosted protease inhibitor (bPI) based regimen at time of randomisation, if previously on non-nucleoside reverse transcriptase inhibitor (NNRTI) has switched at least 4 weeks prior to randomisation
- Adequate haemoglobin (Hb≥12 g/dL for males, ≥11 g/dL for females)
- Weight ≥ 50kg
- Have been vaccinated against coronavirus (COVID-19), at least 4 weeks prior to enrolment
- Females capable of becoming pregnant must agree to use hormonal contraception, intrauterine device, intrauterine hormone-releasing system, or to complete abstinence from at least two weeks before the first bNAb/placebo infusion and for 20 months after the last bNAb/placebo infusion
- 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 or Early stage infection. Estimated time of primary infection will be based on one of the following six criteria: a. Positive HIV-1 serology within a maximum of 24 weeks of a documented negative HIV-1 serology test result (can include point of care test (POCT) using blood for both tests) – The estimated time of infection is taken as the midpoint between the dates of the negative HIV-1 serology or POCT test and positive HIV test at diagnosis. b. The date of a positive p24 antigen result with or without a negative HIV antibody test depending on local lab reporting c. The date of a negative antibody test with either detectable HIV RNA or proviral DNA d. PHE RITA test algorithm reported as “Incident” confirming the HIV-1 antibody avidity is consistent with recent infection (within the preceding 16 weeks). The estimated date of infection is assumed to be two months prior to the date of the incident test result. Asanté™ HIV-1 Rapid Recency® Assay can also be used for recency testing. e. The date of a weakly reactive or equivocal 4th generation HIV antibody antigen test f. The date of an equivocal or reactive antibody test with <4 bands on western blot
- OR, started ART in early stage infection, with nadir CD4 > 500 cells and stable on ART with suppressed undetectable HIV VL ‘target not detected’ (TND) using local assays for >= 1 years (a single viral load measurement > 50 but < 500 copies/mL during this time period is allowable)
- No evidence of viral insensitivity to either 10-1074 or 3BNC117 antibodies based on proviral sequencing algorithm
- HBV sAg or HBV DNA, HCV Ag or HCV RNA negative or anti core antibody negative
- No significant co-morbidities
- Nadir CD4 > 250 cells/μl for those diagnosed with confirmed PHI
What rules you out
- Previous ischaemic heart disease (ST or non-ST myocardial infarction, Q3-risk > 20, stable angina, unstable angina, stroke)
- History of anaphylaxis or severe adverse reaction to antibody infusions, or hypersensitivity to 3BNC117-LS or 10-1074-LS or to any constituent products or excipients thereof
- Treatment with IV immunoglobulin or other monoclonal antibody treatments planned during the duration of the trial
- Clinically significant abnormal blood test results at screening including a. Moderate to severe hepatic impairment as defined by significant liver impairment with evidence of advanced fibrosis or cirrhosis with decompensation b. ALT >5 x ULN c. eGFR <60 d. uPCR >30 mg/mmol e. INR >1.5
- Physical examination findings: Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination and/or vital signs that the investigator believes is a preclusion from enrolment into the study
- Active alcohol or substance use that, in the Investigator’s opinion, will prevent adequate adherence with study requirements
- Insufficient venous access that will allow scheduled blood draws as per protocol
- Concern regarding likelihood of participant not taking precautions to prevent HIV transmission during treatment interruption period
- Pregnancy or breastfeeding
- Any current or past history of malignancy, excluding squamous cell skin cancers
- Concurrent opportunistic infection or other comorbidity or comorbidity likely to occur during the trial e.g. malabsorption syndromes, autoimmune disease
- Any contraindication to receipt of BHIVA recommended combination antiretrovirals
- HTLV-1 co-infection
- SARS-Cov-2 infection confirmed by SARS-Cov-2 RT-PCR positive result from nasopharyngeal swab up to 72 hours prior to randomisation/dosing visit (as per current local NHS guidelines or until such guidelines/practices are no longer applicable/relevant)
- Individuals at high risk from severe COVID-19 disease who may be defined in accordance with NHSE guidance as vulnerable and shielded (as per the view of participant’s physician)
- Current or planned systemic immunosuppressive therapy (inhaled and topical corticosteroids are allowed)
- Participation in any other clinical trial of an experimental agent or any non-interventional study where additional blood draws are required; participation in observational studies is permitted
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.