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NCT03205917 · ClinicalTrials.gov registry record · Phase 1
A Clinical Trial of PGDM1400 and PGT121 and VRC07-523LS Monoclonal Antibodies in HIV-infected and HIV-uninfected Adults
A Phase 1 study, sponsored by International AIDS Vaccine Initiative.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT03205917: Completed Phase 1 study, sponsored by International AIDS Vaccine Initiative.
NCT03205917 is a Phase 1 study that has completed, run by International AIDS Vaccine Initiative. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03205917, a Phase 1 study, has completed, sponsored by International AIDS Vaccine Initiative.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral efficacy of the PGDM1400 and PGT121 and VRC07-523LS mAbs for HIV prevention and therapy.
Primary Outcome
1. Proportion of participants with moderate or greater reactogenicity (e.g., solicited adverse events) for 3 days following IV infusion of PGDM1400 mAb alone, and a combination of PGDM1400 mAb and PGT121 mAb, and a combination of PGDM1400 mAb and PGT121 mAb and VRC07-523LS mAb 2. Proportion of participants with adverse events (AEs), including safety laboratory (biochemical, hematological) parameters, during the first 56 days following IV infusion of PGDM1400 mAb alone and a combination of PGDM14
Interventions
- BIOLOGICAL PGDM1400/Placebo (3mg/kg IV)
- BIOLOGICAL PGDM1400/Placebo (10mg/kg IV)
- BIOLOGICAL PGDM1400/Placebo (30mg/kg IV)
- BIOLOGICAL PGDM1400 + PGT121/Placebo (3mg/kg + 3mg/kg IV)
- BIOLOGICAL PGDM1400 + PGT121/Placebo (10mg/kg + 10mg/kg IV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2017-10-23 |
| Est. Completion | 2020-04-20 |
| Phase | Phase 1 |
What the finished NCT03205917 record still lists
NCT03205917 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 5 interventions - of which PGDM1400/Placebo (3mg/kg IV) is the first listed.
NCT03205917 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03205917 about?
NCT03205917 is a clinical study titled "A Clinical Trial of PGDM1400 and PGT121 and VRC07-523LS Monoclonal Antibodies in HIV-infected and HIV-uninfected Adults". This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral efficacy of the PGDM1400 and PGT121 and VRC07-523LS mAbs for HIV prevention and therapy.
What is the current status of trial NCT03205917?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2017-10-23. Estimated completion is 2020-04-20.
What interventions are being tested in trial NCT03205917?
The interventions under investigation include: PGDM1400/Placebo (3mg/kg IV) (BIOLOGICAL), PGDM1400/Placebo (10mg/kg IV) (BIOLOGICAL), PGDM1400/Placebo (30mg/kg IV) (BIOLOGICAL), PGDM1400 + PGT121/Placebo (3mg/kg + 3mg/kg IV) (BIOLOGICAL), PGDM1400 + PGT121/Placebo (10mg/kg + 10mg/kg IV) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03205917?
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 NCT03205917's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 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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