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Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.

NCT00825929 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 176

Last updated 2025-01-13

No results posted yet for this study

Summary

Due to the potential for pregnancy-induced changes in the pharmacokinetics of medication, one cannot assume that the currently licensed doses of the medication to be tested under this protocol lead to adequate exposure in an HIV-infected pregnant woman. For the agents under study no or limited pharmacokinetic data during pregnancy are available. As the changes in pharmacokinetics during pregnancy are most prominent in the third trimester a pharmacokinetic curve will be recorded in the third trimester after attaining steady state.

Conditions

  • HIV Infections

Sponsors & Collaborators

  • PENTA Foundation

    collaborator NETWORK

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Janssen Pharmaceutica

    collaborator INDUSTRY

  • ViiV Healthcare

    collaborator INDUSTRY

  • Gilead Sciences

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • David M Burger, PharmD PhD · Radboud University Medical Centre Nijmegen

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Belgium
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Entities

Companies

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 NCT00825929 on ClinicalTrials.gov