At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 27 enrolled
Drug / intervention
PGT121 +3 morebiological
Likely dose
PGT121 20 mg/kgfrom 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 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Combinations of Monoclonal Antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS Administered Via Intravenous Infusion in Healthy, HIV-uninfected Adult Participants
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Apr 26, 2019·Updated Jul 11, 2022
In Brief
A Phase 1 clinical trial evaluating PGT121, PGDM1400, and 2 other interventions for HIV Infections. Completed, enrolled 27 participants across 4 sites.
Detailed Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS administered via intravenous infusion in healthy, HIV-uninfected adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedApr 2019
Enrollment StartJul 2019
Primary CompletionMar 2021
TodayJul 2026
First PostedApr 26, 2019
Enrollment StartJul 17, 2019
Primary CompletionMar 25, 2021
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.2 years ago
Interventions
PGT121biological
20 mg/kg administered intravenously
PGDM1400biological
20 mg/kg administered intravenously
10-1074biological
20 mg/kg administered intravenously
VRC07-523LSbiological
20 mg/kg administered intravenously