At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 33 enrolled
Drug / intervention
PGT121.414.LS +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of the Monoclonal Antibody PGT121.414.LS Administered Alone and in Combination With VRC07-523LS Via Intravenous or Subcutaneous Infusions in Healthy, HIV-uninfected Adult Participants
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Dec 26, 2019·Updated Dec 13, 2024
In Brief
A Phase 1 clinical trial evaluating PGT121.414.LS and VRC07-523LS for HIV Infections. Completed, enrolled 33 participants across 5 sites.
Detailed Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of the monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS via intravenous or subcutaneous infusions in healthy, HIV-uninfected adult participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
CollaboratorsHIV Vaccine Trials Network, HIV Prevention Trials Network
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedDec 2019
Enrollment StartNov 2020
Primary CompletionJan 2023
TodayJul 2026
First PostedDec 26, 2019
Enrollment StartNov 10, 2020
Primary CompletionJan 18, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 6.5 years ago
Interventions
PGT121.414.LSbiological
Administered via IV infusion or SC infusion, depending on the arm
VRC07-523LSbiological
Administered via IV infusion or SC infusion, depending on the arm