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NCT03721510 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2a Study of PGT121, VRC07-523LS and PGDM1400 Monoclonal Antibodies in HIV-uninfected and HIV-infected Adults
A Phase 1 study, sponsored by International AIDS Vaccine Initiative.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT03721510: Completed Phase 1 study, sponsored by International AIDS Vaccine Initiative.
NCT03721510 is a Phase 1 study that has completed, run by International AIDS Vaccine Initiative. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03721510, a Phase 1 study, has completed, sponsored by International AIDS Vaccine Initiative.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
This is a Phase 1/2a open label study to evaluate the safety, tolerability, pharmacokinetics and anti-viral activity of PGT121, VRC07-523LS and PGDM1400 for HIV prevention and therapy.
Primary Outcome
Proportion of volunteers with moderate or greater reactogenicity (i.e., solicited adverse events) for 3 days following each IV infusion of PGT121, VRC07-523LS and PGDM1400 as assessed using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017, or the Common Terminology Criteria for Adverse Events (CTCAE,) Version 5.0 27 November 2017 (for reactogenicity observed within the first 24 hours post-infusion.)
Interventions
- BIOLOGICAL PGT121 + VRC07-523LS
- BIOLOGICAL PGT121 + VRC07-523LS + PGDM1400
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2018-12-03 |
| Est. Completion | 2022-05-02 |
| Phase | Phase 1 |
What the finished NCT03721510 record still lists
NCT03721510 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which PGT121 + VRC07-523LS is the first listed.
NCT03721510 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03721510 about?
NCT03721510 is a clinical study titled "A Phase 1/2a Study of PGT121, VRC07-523LS and PGDM1400 Monoclonal Antibodies in HIV-uninfected and HIV-infected Adults". This is a Phase 1/2a open label study to evaluate the safety, tolerability, pharmacokinetics and anti-viral activity of PGT121, VRC07-523LS and PGDM1400 for HIV prevention and therapy.
What is the current status of trial NCT03721510?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2018-12-03. Estimated completion is 2022-05-02.
What interventions are being tested in trial NCT03721510?
The interventions under investigation include: PGT121 + VRC07-523LS (BIOLOGICAL), PGT121 + VRC07-523LS + PGDM1400 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03721510?
This trial is sponsored by International AIDS Vaccine Initiative, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03721510's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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