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NCT02960581 · ClinicalTrials.gov registry record · Phase 1
Safety, PK and Antiviral Activity of PGT121 Monoclonal Antibody in HIV-uninfected and HIV-infected Adults
A Phase 1 study, sponsored by International AIDS Vaccine Initiative.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT02960581: Completed Phase 1 study, sponsored by International AIDS Vaccine Initiative.
NCT02960581 is a Phase 1 study that has completed, run by International AIDS Vaccine Initiative. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02960581, a Phase 1 study, has completed, sponsored by International AIDS Vaccine Initiative.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral efficacy of the PGT121 monoclonal antibody for HIV prevention and therapy.
Primary Outcome
The investigators will measure the following endpoints to evaluate the safety and tolerability of PGT121 mAb in HIV-uninfected and HIV-infected adults: 1. Proportion of participants with moderate or greater reactogenicity (e.g., solicited adverse events) for 3 days following IV infusion of PGT121 mAb. 2. Proportion of participants with moderate or greater and/or PGT121 mAb-related unsolicited adverse events (AEs), including safety laboratory (biochemical, hematological) parameters, following IV
Interventions
- BIOLOGICAL PGT121 3mg/kg IV
- BIOLOGICAL PGT121 10mg/kg IV
- BIOLOGICAL PGT121 30mg/kg IV
- BIOLOGICAL PGT121 3mg/kg SC
- BIOLOGICAL Placebo (0.9% Sodium Chloride Injection USP (Saline))
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2016-11 |
| Est. Completion | 2019-07-08 |
| Phase | Phase 1 |
What the finished NCT02960581 record still lists
NCT02960581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 5 interventions - of which PGT121 3mg/kg IV is the first listed.
NCT02960581 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02960581 about?
NCT02960581 is a clinical study titled "Safety, PK and Antiviral Activity of PGT121 Monoclonal Antibody in HIV-uninfected and HIV-infected Adults". This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral efficacy of the PGT121 monoclonal antibody for HIV prevention and therapy.
What is the current status of trial NCT02960581?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2016-11. Estimated completion is 2019-07-08.
What interventions are being tested in trial NCT02960581?
The interventions under investigation include: PGT121 3mg/kg IV (BIOLOGICAL), PGT121 10mg/kg IV (BIOLOGICAL), PGT121 30mg/kg IV (BIOLOGICAL), PGT121 3mg/kg SC (BIOLOGICAL), Placebo (0.9% Sodium Chloride Injection USP (Saline)) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02960581?
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 NCT02960581's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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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