CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 52 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.

Search/NCT01780831
NCT01780831Phase 1Completed
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A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Raltegravir in HIV-1-Exposed Neonates at Risk of Acquiring HIV-1 Infection

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jan 31, 2013·Updated Nov 5, 2021

In Brief

A Phase 1 clinical trial evaluating Raltegravir for HIV Infections. Completed, enrolled 52 participants across 15 sites in 5 countries.

Detailed Summary

The purpose of this study was to evaluate the safety and pharmacokinetics (PK) of raltegravir (RAL) when given to HIV-1-exposed, normal birth weight newborn infants at risk of acquiring HIV-1 infection. (PK is the study of the time course of absorption, distribution, metabolism, and excretion of drugs in the body.) The primary goal of this study was to determine a dose of RAL that was safe and met the PK targets for infants when administered during the first 6 weeks of life in addition to standard of care antiretroviral (ARV) agents for prevention of perinatal transmission.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesBrazil, Puerto Rico, South Africa, Thailand, United States
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 31, 2013
Enrollment StartJan 28, 2014
Primary CompletionDec 14, 2017
Study CompletionApr 20, 2018
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 13.4 years ago

Interventions

Raltegravirdrug

RAL was given as oral granules for suspension.