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NCT02140255 · ClinicalTrials.gov registry record · Phase 1

Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission

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

Recruiting
Registry status
Phase 1
Development phase
1,120
Enrollment target
20
Study locations

NCT02140255 is a Phase 1 study of HIV Infection that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,120 participants, above the 227-participant average among 73 other HIV Infection trials with a reported enrollment target (393% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT02140255, a Phase 1 study of HIV Infection, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

RECRUITING
Registry status
Phase 1
Development phase
1,120 participants
Enrollment target
20
Study locations

Study Summary

The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.

Conditions Studied

Interventions

  • DRUG Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
  • DRUG Nevirapine (NVP)
  • DRUG Lopinavir/Ritonavir (LPV/r)
  • DRUG Raltegravir (RAL)
  • DRUG VRC01

Study Locations (20)

Florida

  • 5055, South Florida CDTC Fort Lauderdale Clinical Research Site - Fort Lauderdale
  • 5051, University of Florida Center for HIV/AIDS Research, Education and Service (UF CARES) Clinical Research Site - Jacksonville
  • 5127, Pediatric Perinatal HIV Clinical Research Site - Miami
  • University of Miami CRS - Miami

California

  • 4601, University of California, San Diego Clinical Research Site - La Jolla
  • 5048, University of Southern California Clinical Research Site - Los Angeles
  • 5112, David Geffen School of Medicine at UCLA Clinical Research Site - Los Angeles

New York

  • 5040, SUNY Stony Brook Clinical Research Site - Stony Brook
  • 5114, Bronx Lebanon Hospital Center Clinical Research Site - The Bronx
  • 5013, Jacobi Medical Center Clinical Research Site - The Bronx

Illinois

  • 5083, Rush University Cook County Hospital Clinical Research Site - Chicago
  • 4001, Lurie Children's Hospital of Chicago Clinical Research Site - Chicago

Texas

  • Texas Children's Hospital CRS - Houston
  • 5128, Baylor College of Medicine/Texas Children's Hospital Clinical Research Site - Houston

Colorado

  • 5052, University of Colorado, Denver Clinical Research Site - Aurora

Georgia

  • Emory University School of Medicine NICHD CRS - Atlanta

Maryland

  • 5092, Johns Hopkins Clinical Research Site - Baltimore

Trial Details

FieldValue
Enrollment Target 1,120 participants
Start Date 2015-01-23
Est. Completion 2031-12-31
Phase Phase 1

What the Registry Record Tells You About NCT02140255

The ClinicalTrials.gov registry entry for NCT02140255 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 1,120 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 227-participant average among 73 other HIV Infection trials with a reported enrollment target (393% higher). 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 Infection appearing as the primary indexed condition, and to 5 interventions - of which Nucleoside Reverse Transcriptase Inhibitors (NRTIs) is the first listed.

NCT02140255 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, California, New York.

Frequently Asked Questions

What is clinical trial NCT02140255 about?

NCT02140255 is a clinical study titled "Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission". The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.

What is the current status of trial NCT02140255?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 1,120 participants. The study started on 2015-01-23. Estimated completion is 2031-12-31.

What conditions does trial NCT02140255 study?

This clinical trial studies the following conditions: HIV Infection.

What interventions are being tested in trial NCT02140255?

The interventions under investigation include: Nucleoside Reverse Transcriptase Inhibitors (NRTIs) (DRUG), Nevirapine (NVP) (DRUG), Lopinavir/Ritonavir (LPV/r) (DRUG), Raltegravir (RAL) (DRUG), VRC01 (DRUG).

Who is sponsoring clinical trial NCT02140255?

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 NCT02140255 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. 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 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.