Optimal Dosing of 1st Line Antituberculosis and Antiretroviral Drugs in Children (a Pharmacokinetic Study)
Status:
Completed
Trial end date:
2017-07-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
University of Cape Town
Collaborators:
Liverpool School of Tropical Medicine University of North Carolina Uppsala University