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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04212091
The ClinicalTrials.gov registry entry for NCT04212091 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 5 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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