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Abacavir and Lamivudine PK in Children

NCT01656122 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-02-22

No results posted yet for this study

Summary

The purpose of this study is to assess the pharmacokinetic parameters for ABC and 3TC in HIV-infected children younger than 18 years old with body weight ≥ 14 kgs.

Conditions

Interventions

DRUG

abacavir

Dosing of ABC will be according to the WHO guidelines by weight band for twice daily dosing. The once daily dosing will use the same mg/day as the twice daily dosing for that weight band

DRUG

3TC

Dosing of 3TC will be according to the WHO guidelines by weight band for twice daily dosing. The once-daily dosing will use the same mg/day as the twice-daily dosing for that weight band

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • amfAR, The Foundation for AIDS Research

    collaborator OTHER

  • PHPT/AMS Laboratory, Faculty of Associated Medical Sciences, Chiang Mai University

    collaborator UNKNOWN

  • Chulalongkorn University

    collaborator OTHER

  • ViiV Healthcare

    collaborator INDUSTRY

  • The HIV Netherlands Australia Thailand Research Collaboration

    lead OTHER

Principal Investigators

  • Jintanat Ananworanich, MD, PhD · The HIV Netherlands Australia Thailand Research Collaboration

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

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 NCT01656122 on ClinicalTrials.gov