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Optimal Dosing of 1st Line Antituberculosis and Antiretroviral Drugs in Children (a Pharmacokinetic Study)

NCT01637558 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-10-27

No results posted yet for this study

Summary

The aims of this project are to:

1. To evaluate the pharmacokinetics of first line antituberculosis drugs (isoniazid, rifampicin, pyrazinamide and ethambutol) when applying the 2010 WHO/IUATLD dosing guidelines across pediatric populations (0-12 years of age, HIV infected and uninfected, and with varied nutritional status) in Cape Town, South Africa and Blantyre, Malawi.
2. To evaluate an 8-hourly weight band-based dosing strategy for lopinavir/ritonavir using the commercially available lopinavir/ritonavir (4:1 ratio) in children in South Africa receiving rifampicin-based antituberculosis treatment.
3. To evaluate the pharmacokinetics of nevirapine in children in Malawi receiving rifampicin-based antituberculosis treatment.

Conditions

Interventions

DRUG

8 hourly LPV/r during TB treatment

8 hourly LPV/r during TB treatment

DRUG

Nevirapine

DRUG

Lopinavir/Ritonavir

Sponsors & Collaborators

  • Liverpool School of Tropical Medicine

    collaborator OTHER

  • Uppsala University

    collaborator OTHER

  • University of North Carolina

    collaborator OTHER

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Helen M McIlleron, PhD · University of Cape Town

  • Heather Zar, PhD · University of Cape Town

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • Malawi
  • South Africa

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 NCT01637558 on ClinicalTrials.gov