BridgeMD
New treatment option for HIV/AIDS and Infections
Official title A Randomised Placebo Controlled Trial of ART Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs).
ClinicalTrials.gov ID: NCT04319367
What this study is testing
What is Investigational Medicinal Product?
Investigational Medicinal Product is an investigational medicine, being studied as a potential treatment for hiv/aids and infections.
Also referred to as 10-1074-LS and 3BNC117-LS.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- 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...
See the full eligibility 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
- 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 date of a positive p24 antigen result with or without a negative HIV antibody test depending on local laboratory reports
- The date of a negative antibody test with either detectable HIV RNA or proviral DNA
- 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...
- The date of a weakly reactive or equivocal 4th generation HIV antibody antigen test
- 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...
- 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...
- 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...
- 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...
- 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-treatment 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
- Moderate to severe hepatic impairment as defined by significant liver impairment with evidence of advanced fibrosis or cirrhosis with decompensation
- ALT \>5 x ULN
- eGFR \<60
- uPCR \>30 mg/mmol
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Denmark
- Brighton, United Kingdom
- Edinburgh, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- Oxford, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Denmark; Brighton, United Kingdom; Edinburgh, United Kingdom; London, United Kingdom; Manchester, United Kingdom; Oxford, 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 ClinicalTrials.gov; the study team decides eligibility.