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NCT04212091 · ClinicalTrials.gov registry record · Phase 1
Evaluating 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
A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 5
- Study locations
NCT04212091: Completed Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04212091 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 33 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04212091, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Conditions Studied
Interventions
- BIOLOGICAL VRC07-523LS
- BIOLOGICAL PGT121.414.LS
Study Locations (5)
California
- UCLA CARE Center CRS - Los Angeles
District of Columbia
- George Washington Univ. CRS - Washington D.C.
Georgia
- The Hope Clinic of the Emory Vaccine Center CRS - Decatur
Massachusetts
- Brigham and Women's Hospital Vaccine CRS (BWH VCRS) - Boston
New York
- Columbia P&S CRS - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2020-11-10 |
| Est. Completion | 2023-01-18 |
| Phase | Phase 1 |
What the finished NCT04212091 record still lists
NCT04212091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which VRC07-523LS is the first listed.
NCT04212091 lists 5 locations in 5 states (California, District of Columbia, Georgia).
Frequently Asked Questions
What is clinical trial NCT04212091 about?
NCT04212091 is a clinical study titled "Evaluating 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". 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.
What is the current status of trial NCT04212091?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2020-11-10. Estimated completion is 2023-01-18.
What conditions does trial NCT04212091 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT04212091?
The interventions under investigation include: VRC07-523LS (BIOLOGICAL), PGT121.414.LS (BIOLOGICAL).
Who is sponsoring clinical trial NCT04212091?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04212091 being conducted?
This trial has 5 study locations across California, District of Columbia, Georgia, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04212091's enrollment target sits among peer trials
33 417th of 542 higher than 123 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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