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NCT01828073 · ClinicalTrials.gov registry record

Evaluating the Safety and Pharmacokinetics of Raltegravir in Infants

A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
40
Enrollment target

NCT01828073 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 40 participants.

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The verdict

NCT01828073 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
40 participants
Enrollment target

Study Summary

The purpose of this study was to determine the washout pharmacokinetics (PK) and safety of in utero/intrapartum exposure to maternal raltegravir (RAL) in infants born to pregnant women with HIV infection who received RAL 400 mg twice daily. The study also provided data for the development of an infant RAL starting dosing regimen for IMPAACT P1110 (NCT01780831).

Interventions

  • DRUG Raltegravir

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2011-05-19
Est. Completion 2018-04-23

What the Registry Record Tells You About NCT01828073

The ClinicalTrials.gov registry entry for NCT01828073 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 0 conditions, and to 1 intervention - of which Raltegravir is the first listed.

NCT01828073 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01828073 about?

NCT01828073 is a clinical study titled "Evaluating the Safety and Pharmacokinetics of Raltegravir in Infants". The purpose of this study was to determine the washout pharmacokinetics (PK) and safety of in utero/intrapartum exposure to maternal raltegravir (RAL) in infants born to pregnant women with HIV infection who received RAL 400 mg twice daily. The study also provided data for the development of an infa...

What is the current status of trial NCT01828073?

This trial is currently completed. The enrollment target is 40 participants. The study started on 2011-05-19. Estimated completion is 2018-04-23.

What interventions are being tested in trial NCT01828073?

The interventions under investigation include: Raltegravir (DRUG).

Who is sponsoring clinical trial NCT01828073?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

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.