Skip to content
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Pharmacokinetics of generic and trade formulations of lamivudine, stavudine and nevirapine in HIV-infected Malawian children
Antiviral Therapy, Volume 15, No. 1, Year 2010
Notification
URL copied to clipboard!
Description
Background: The aim of this study was to evaluate the pharmacokinetics of lamivudine (3TC), stavudine (d4T) and nevirapine (NVP) in HIV-infected Malawian children receiving quartered tablet multiples of Triomune 40™ (generic tablet [GT]) compared with individual generic liquid (GL) and trade liquid (TL). Methods: This was a prospective randomized three-way crossover study. Patients (8-<12 kg, 18-<22 kg or 28-<32 kg body weight) taking Triomune 40™ were recruited and randomized to receive GT twice daily (one-quarter, one-half or three-quarter tablets using Malawi treatment guidelines), GL twice daily (in the equivalent dose of GT) or TL twice daily (dosed using weight and age from US Department of Health and Human Services paediatric treatment guidelines). After 10 days of one formulation, 6-h pharmacokinetic sampling was performed, and patients were crossed over to subsequent formulations. Baseline concentration (C0 h), area under the curve (AUC)0-6 h, maximum plasma concentration (Cmax) and time to Cmax were generated for each antiretroviral treatment. Results: A total of 7 males and 11 females (6 in each GT dosing group) with a median (range) age of 7.2 years (1.3- 13.6), weight of 19 kg (9.0-30.5) and height of 109 cm (75-132) were recruited. Combining all patients, no difference in pharmacokinetics was noted among the formulations for all drugs. However, patients in the onequarter GT dosing group (8-<12 kg) had lower 3TC exposures than with the GL or TL (3TC AUC0-6 h 1,102, 1,720 and 2,060 h·ng/ml, respectively; P<0.005) and had more subtherapeutic NVP C0 h (10 of 13 occasions versus the one-half and three-quarter tablet groups). Compared with Western paediatric cohorts, Malawians had concentrations 30-40% lower for 3TC and d4T and 50% higher for NVP. Conclusions: Quartered multiples of Triomune 40™ are appropriate for children 18-<22 kg and 28-<32 kg in weight; however, alternative formulations are suggested in children weighing 8-<12 kg. ©2010 International Medical Press.
Authors & Co-Authors
Corbett, Amanda H.
United States, Chapel Hill
The University of North Carolina at Chapel Hill
Hosseinipour, Mina C.
United States, Chapel Hill
The University of North Carolina at Chapel Hill
Malawi, Lilongwe
Unc Project-malawi
Nyirenda, Jean
Malawi, Lilongwe
Unc Project-malawi
Kanyama, Cecilia C.
Malawi, Lilongwe
Unc Project-malawi
Rezk, Naser L.
United States, Chapel Hill
The University of North Carolina at Chapel Hill
Mkupani, Pax
Malawi, Lilongwe
Unc Project-malawi
Sichali, Dorothy S.
Malawi, Lilongwe
Unc Project-malawi
Tien, Hsiaochuan
United States, Chapel Hill
The University of North Carolina at Chapel Hill
Kashuba, Angela D.M.
United States, Chapel Hill
The University of North Carolina at Chapel Hill
Mwansambo, Charles C.V.
Malawi, Lilongwe
Kamuzu Central Hospital
Weigel, Ralf
Malawi, Lilongwe
Lighthouse Trust
Kazembe, Peter Nicholas
Malawi, Lilongwe
Baylor College of Medicine Children's Foundation Malawi
Statistics
Citations: 17
Authors: 12
Affiliations: 5
Identifiers
Doi:
10.3851/IMP1488
ISSN:
13596535
Research Areas
Infectious Diseases
Maternal And Child Health
Study Design
Cohort Study
Study Locations
Malawi
Participants Gender
Female