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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

A Randomised Placebo Controlled Trial of ART Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs). (NCT04319367) is a Phase 2 interventional studying HIV/AIDS and Infections, sponsored by Imperial College London. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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).

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against HIV/AIDS and Infections and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 72 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused HIV/AIDS and Infections subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 infection will be based on one of the following six criteria 1. 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 2. The date of a positive p24 antigen result with or without a negative HIV antibody test depending on local laboratory reports 3. The date of a negative antibody test with either detectable HIV RNA or proviral DNA 4. 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. 5. The date of a weakly reactive or equivocal 4th generation HIV antibody antigen test 6. 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 infection will be based on one of the following six criteria 1. 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 2. The date of a positive p24 antigen result with or without a negative HIV antibody test depending on local laboratory reports 3. The date of a negative antibody test with either detectable HIV RNA or proviral DNA 4. 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. 5. The date of a weakly reactive or equivocal 4th generation HIV antibody antigen test 6. 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 * Current CD4 count \> 500 cells/µL or CD4:CD8 ratio \>1 * On integrase inhibitor (INSTI) or boosted protease inhibitor (PI) 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 ≥50 kg * 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 infusion. Exclusion Criteria: * Previous ischaemic heart disease (ST or non-ST myocardial infarction, Q3-risk \> 20, stable angina, unstable angina, stroke) * 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 maybe 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 or 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 an observational studies is permitted * History of anaphylaxis or severe adverse reaction to antibody infusions, or hypersensitivity to 3BNC117-LS or 10-1074-LS or to or 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 1. Moderate to severe hepatic impairment as defined by significant liver impairment with evidence of advanced fibrosis or cirrhosis with decompensation 2. ALT \>5 x ULN 3. eGFR \<60 4. uPCR \>30 mg/mmol 5. 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

Treatments Being Tested

DRUG

Investigational Medicinal Product

Recombinant human monoclonal antibody (mAb) or placebo

Locations (12)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04319367), the sponsor (Imperial College London), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04319367 clinical trial studying?

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). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04319367?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04319367?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04319367. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04319367. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.