Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT04319367
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04319367
Study Brief:
Protocol Section:
NCT04319367