Phase
Condition
N/ATreatment
Investigational Medicinal Product
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
- Positive HIV-1 serology within a maximum of 24 weeks of a documented negativeHIV-1 serology test result (can include point of care test (POCT) using blood forboth tests) - The estimated time of infection is taken as the midpoint betweenthe dates of the negative HIV-1 serology or POCT test and positive HIV test atdiagnosis
- The date of a positive p24 antigen result with or without a negative HIV antibodytest depending on local laboratory reports
- The date of a negative antibody test with either detectable HIV RNA or proviralDNA
- PHE RITA test algorithm reported as "Incident" confirming the HIV-1 antibodyavidity is consistent with recent infection (within the preceding 16 weeks). Theestimated date of infection is assumed to be two months prior to the date of theincident test result. Asanté™ HIV-1 Rapid Recency® Assay can also be used forrecency testing.
- The date of a weakly reactive or equivocal 4th generation HIV antibody antigentest
- 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 ARTwith 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 timeperiod is allowable)
- No evidence of viral insensitivity to either 10-1074 or 3BNC117 antibodies based onproviral 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 attime 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 toenrolment
- Females capable of becoming pregnant* must agree to use hormonal contraception,intrauterine device, intrauterine hormone-releasing system, or to completeabstinence** from at least two weeks before the first bNAb/placebo infusion and for 20months after the last bNAb infusion.
Exclusion
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 occurduring 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 fromnasopharyngeal swab up to 72 hours prior to randomisation/dosing visit (as per currentlocal NHS guidelines or until such guidelines/practices are no longerapplicable/relevant)
- Individuals at high risk from severe COVID-19 disease who maybe defined in accordancewith NHSE guidance as vulnerable and shielded (as per the view of participant'sphysician)
- Current or planned systemic immunosuppressive therapy (inhaled or topicalcorticosteroids are allowed)
- Participation in any other clinical trial of an experimental agent or anynon-interventional study where additional blood draws are required; participation inan observational studies is permitted
- History of anaphylaxis or severe adverse reaction to antibody infusions, orhypersensitivity to 3BNC117-LS or 10-1074-LS or to or any constituent products orexcipients thereof
- Treatment with IV immunoglobulin or other monoclonal antibody treatments plannedduring the duration of the trial
- Clinically significant abnormal blood test results at screening including
- Moderate to severe hepatic impairment as defined by significant liver impairmentwith 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 clinicallysignificant deviation from normal in physical examination and/or vital signs that theinvestigator believes is a preclusion from enrolment into the study.
- Active alcohol or substance use that, in the Investigator's opinion, will preventadequate 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 HIVtransmission during treatment interruption period
- Pregnancy or breastfeeding
Study Design
Study Description
Connect with a study center
Aarhus University Hospital
Aarhus,
DenmarkActive - Recruiting
University Hospitals Sussex NHS Foundation Trust
Brighton,
United KingdomActive - Recruiting
Western General Hospital
Edinburgh,
United KingdomActive - Recruiting
Barts Health NHS Trust
London,
United KingdomActive - Recruiting
Chelsea And Westminster Hospital NHS Foundation Trust
London,
United KingdomActive - Recruiting
Guy's and St Thomas' NHS Foundation Trust
London,
United KingdomActive - Recruiting
Imperial College NHS Healthcare Trust
London, W2 1NY
United KingdomActive - Recruiting
Mortimer Market CNWL Hospital NHS Foundation Trust
London,
United KingdomActive - Recruiting
Royal Free London NHS Foundation Trust
London,
United KingdomActive - Recruiting
St Georges Hospital NHS Foundation Trust
London,
United KingdomActive - Recruiting
Manchester University NHS Foundation Trust
Manchester,
United KingdomActive - Recruiting
Oxford University Hospitals
Oxford,
United KingdomActive - Recruiting


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