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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: Completed study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Time required for neonatal plasma concentration to decrease by one-half. T1/2 was estimated using the terminal 3 concentration-time points for each infant when available.
Interventions
- DRUG Raltegravir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2011-05-19 |
| Est. Completion | 2018-04-23 |
What the finished NCT01828073 record still lists
NCT01828073 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Raltegravir is the first listed.
NCT01828073 does not publish any study locations in the registry export this page uses.
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.
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