HIV/AIDS Paediatrics
Conditions
Interventions
ePGT121v1LS
Saline
Sponsors
SERMAS Fundacion Hospital 12 de Octubre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Infants from 1 to 365 days old at the time of enrolment. • Living with HIV-1, diagnosed with an approved assay detecting HIV nucleic acids in blood. • Weight > 2.5 kg at enrolment. • ART-naïve or = 30 days of triple ART at screening (not including prophylaxis in HIV-exposed). • Clinically stable and can be managed as outpatient (participants identified in-hospital can start the trial at their first routine visit). • Parent or legal guardian provides Informed consent (IC).
Exclusion criteria
Exclusion criteria: • Participation in other concurrent research studies that, in the opinion of the principal investigator and central team, would interfere with the objectives of this study. • Previous receipt of bNAbs against HIV. • Serious Adverse Reactions (SARs) to the investigational medicinal product (IMP) or its components. • Intravenous (IV) immunoglobulins received within 90 days before IMP administration. • Any clinically significant acute or chronic illness or condition at screening that, in the opinion of the principal investigator/designee, renders the participant unfit to participate in the study or jeopardizes the safety or rights of the participant. Including, but not restricted to: • Evidence of active tuberculosis (TB) disease at the time of enrolment. • Life-threatening condition associated with a high risk of death within 30 days of enrolment, as determined by the study clinician. • Severe acute malnutrition with complications. • Severe neurological illness. • Hemodynamically significant severe congenital heart disease. • Active malignancies. • Life-threatening bleeding disorder. • Use of systemic immunosuppressive drugs within 30 days before first IMP administration. Not exclusionary: nasal steroid spray, inhaled steroids, topical steroids, a single course of oral/parenteral prednisone or equivalent at 2 mg/kg/day, and length of therapy <14 days. • Unwillingness to have blood drawn • Unable to receive SC medications. • Chronic or recurrent urticaria or any other chronic dermatological condition that may be confused with local Adverse Reactions (ARs). • Any social or medical condition in the caregivers that, in the judgement of the investigator, would interfere with protocol adherence, completion of the trial or assessment of safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (Serious adverse events) Proportion of participants experiencing SAEs throughout the whole trial.;Virological suppression (snapshot) • Proportion of infants achieving virological suppression (plasma HIV-1 RNA < 40 copies/mL) at week 48, as well as over the 48 week follow-up period.;Time to virological suppression • Time to first virological suppression, defined as the time from randomization to the first post-baseline measurement of plasma HIV-1 RNA < 40 copies/mL.;Tolerability of the treatment (participants who discontinue) • Proportion of participants who discontinue due to toxicity or tolerability issues.;Tolerability of the injection • Median score of pain assessment scale after administration of bNAb (FLACC scale). | — |
Secondary
| Measure | Time frame |
|---|---|
| PK profile of ePGT121v1-LS Half-life;Time to sustained virological suppression Time from randomization to the first scheduled post-baseline visit at which HIV-1 RNA is < 40 copies/mL, provided that all subsequent scheduled HIV-1 RNA measurements through week 48 also remain < 40 copies/mL.;Longitudinal virological response Proportion of participants with HIV-1 RNA < 40 copies/mL at weeks 12, 24, 36, and 48 will be recorded as the endpoint and log change in plasma HIV-1 RNA levels relative to baseline and subsequent pre-dose measurements.;Acceptability The acceptability will be assessed through a series of qualitative interviews and limited quantitative assessments.;Adverse events Number of and proportion of participants with solicited adverse event (AEs) and laboratory-related AEs. | — |
Countries
South Africa
Contacts
Public ContactAnnabelle Gachet
Project Manager
Outcome results
None listed