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Evaluating the Safety and Pharmacokinetics of Raltegravir in Infants

NCT01828073 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2021-11-08

Study results available
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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).

Conditions

  • HIV Infections

Interventions

DRUG

Raltegravir

No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Diana F. Clarke, PharmD · Boston Medical Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-19
Primary Completion
2018-04-23
Completion
2018-04-23

Countries

  • United States
  • Brazil
  • South Africa
  • Tanzania
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01828073 on ClinicalTrials.gov