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NCT02256631 · ClinicalTrials.gov registry record · Phase 1

Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants

A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
83
Enrollment target
14
Study locations

NCT02256631 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 83 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (81% lower). The trial reports 14 study locations across 10 states.

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The verdict

NCT02256631, 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
83 participants
Enrollment target
14
Study locations

Study Summary

The purpose of this study was to assess the safety and pharmacokinetics (PK) of three monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at increased risk of mother-to-child HIV transmission.

Conditions Studied

HIV Infections

Interventions

  • BIOLOGICAL VRC07-523LS
  • BIOLOGICAL VRC01
  • BIOLOGICAL VRC01LS

Study Locations (14)

Florida

  • South Florida CDTC Ft Lauderdale NICHD CRS - Fort Lauderdale
  • Univ. of Florida Jacksonville NICHD CRS - Jacksonville
  • Pediatric Perinatal HIV Clinical Trials Unit CRS - Miami

New York

  • Bronx-Lebanon Hospital Center NICHD CRS - The Bronx
  • Jacobi Med. Ctr. Bronx NICHD CRS - The Bronx

Other

  • University of Puerto Rico Pediatric HIV/AIDS Research Program CRS - San Juan
  • Harare Family Care CRS - Harare

California

  • David Geffen School of Medicine at UCLA NICHD CRS - Los Angeles

Colorado

  • Univ. of Colorado Denver NICHD CRS - Aurora

Georgia

  • Emory University School of Medicine NICHD CRS - Atlanta

Maryland

  • Johns Hopkins Univ. Baltimore NICHD CRS - Baltimore

Texas

  • Texas Children's Hospital CRS - Houston

Trial Details

FieldValue
Enrollment Target 83 participants
Start Date 2015-06-30
Est. Completion 2021-12-16
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02256631

The ClinicalTrials.gov registry entry for NCT02256631 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 83 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 (81% 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 3 interventions - of which VRC07-523LS is the first listed.

NCT02256631 reports 14 study locations spanning 10 distinct geographic areas - top geographies include Florida, New York, Other.

Frequently Asked Questions

What is clinical trial NCT02256631 about?

NCT02256631 is a clinical study titled "Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants". The purpose of this study was to assess the safety and pharmacokinetics (PK) of three monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at increased risk of mother-to-child HIV transmission.

What is the current status of trial NCT02256631?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2015-06-30. Estimated completion is 2021-12-16.

What conditions does trial NCT02256631 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT02256631?

The interventions under investigation include: VRC07-523LS (BIOLOGICAL), VRC01 (BIOLOGICAL), VRC01LS (BIOLOGICAL).

Who is sponsoring clinical trial NCT02256631?

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 NCT02256631 being conducted?

This trial has 14 study locations across California, Colorado, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.