National Principal Investigator:
Professor Helen McIlleron (Department of Pharmacology, Groote Schuur Hospital)

Site Principal Investigator:
Heather J. Zar (Department of Paediatrics and Child Health, Red Cross War Memorial Children’s Hospital, UCT)

Study profile
HIV and tuberculosis are a major health problem in children. Challenges to treat children with tuberculosis include a lack of knowledge about optimal dosing of the first line antituberculosis drugs across the ages, nutritional status and HIV infection status, the absence of an appropriate regimen to co-administer rifampin and lopinavir/ritonavir, the key first line drugs for tuberculosis and HIV, and uncertainty about NVP exposure in young children during rifampin-based tuberculosis therapy. This specific 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 a 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.

Study Co-Ordinator
Sr Margaretha Prins
Tel:  021-658-5524 or 021-658-5518