At a glance
ClinicalIndex Comparison RecordN/ACompleted· 40 enrolled
Drug / intervention
Raltegravirdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Raltegravir Pharmacokinetics and Safety in Neonates
National Institute of Allergy and Infectious Diseases (NIAID)·observational·Posted Apr 10, 2013·Updated Nov 8, 2021
In Brief
An observational study evaluating Raltegravir for HIV Infections. Completed, enrolled 40 participants across 19 sites in 5 countries.
Detailed 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).
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesBrazil, South Africa, Tanzania, Thailand, United States
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2011
First PostedApr 2013
Primary CompletionApr 2018
TodayJul 2026
First PostedApr 10, 2013
Enrollment StartMay 19, 2011
Primary CompletionApr 23, 2018
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 13.2 years ago
Interventions
Raltegravirdrug
No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.