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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 is a Phase 1 study that has completed, run by International AIDS Vaccine Initiative. The registered enrollment target is 48 participants.

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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.

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

FieldValue
Enrollment Target 48 participants
Start Date 2016-11
Est. Completion 2019-07-08
Phase Phase 1

What the Registry Record Tells You About NCT02960581

The ClinicalTrials.gov registry entry for NCT02960581 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is International AIDS Vaccine Initiative, which has 16 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which PGT121 3mg/kg IV is the first listed.

NCT02960581 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.