A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV
Phase 1
18–65
1 site in MD
What this study is about
This Phase 1 study is focused on people with hiv. The primary outcome being measured is Part B - Change from baseline in HIV log10 plasma viral load prior to cART initiation.
Simplified from trial records by PatientMatch.
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Assignment is predetermined by the study protocol.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Part B - Change from baseline in HIV log10 plasma viral load prior to cART initiation, Part B - Maximum decrease from baseline in HIV log10 plasma viral load prior to cART initiation, Part B - Time from dosing to lowest viral load prior to cART initiation, Part B - Time from dosing to viral rebound defined as HIV-1 RNA viral load increase >0.75 log10 copies/mL from nadir (i.e., lowest HIV-1 RNA viral load from 7 days post-dose (Visit 3) and through pre-cART initiation), Parts A and B (except for Cohort A1) - Occurrence of infusion-related reactions (IRRs) Grade ≥2 (graded based on National Cancer Institute Common Terminology Criteria for AEs [NCI CTCAE] version 5.0 as specified in the protocol), Parts A and B - Occurrence of at least one adverse event (AE), Parts A and B - Occurrence of at least one serious AE (SAE), Parts A and B - Occurrence of at least one solicited local reaction (pain/tenderness, erythema/redness, induration/swelling) at the investigational medicinal product administration site
Secondary: Parts B - Change from baseline in CD4+ T cell count
Immune, Infectious