Abacavir, zidovudine, or stavudine as paediatric tablets for African HIV-infected children (CHAPAS-3): an open-label, parallel-group, randomised controlled trial

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dc.contributor.authorMulenga, Veronica
dc.contributor.authorMusiime, Victor.
dc.contributor.authorKekitiinwa, Adeodata
dc.contributor.authorCook, Adrian D
dc.contributor.authorAbongomera, George
dc.contributor.authorKenny, Julia
dc.contributor.authorChabala, Chisala
dc.contributor.authorMirembe, Grace
dc.contributor.authorAsiimwe, Alice
dc.contributor.authorOwen-Powell, Ellen
dc.contributor.authorBurger, David
dc.contributor.authorMcIlleron, Helen
dc.contributor.authorKlein, Nigel.
dc.contributor.authorChintu, Chifumbe
dc.contributor.authorThomason, Margaret J.
dc.contributor.authorKityo, Cissy.
dc.contributor.authorWalker, Sarah A.
dc.contributor.authorGibb, Diana M
dc.date.accessioned2021-12-10T10:37:22Z
dc.date.available2021-12-10T10:37:22Z
dc.date.issued2016
dc.description.abstractBackground WHO 2013 guidelines recommend universal treatment for HIV-infected children younger than 5 years. No paediatric trials have compared nucleoside reverse-transcriptase inhibitors (NRTIs) in first-line antiretroviral therapy (ART) in Africa, where most HIV-infected children live. We aimed to compare stavudine, zidovudine, or abacavir as dual or triple fi xed-dose-combination paediatric tablets with lamivudine and nevirapine or efavirenz. Methods In this open-label, parallel-group, randomised trial (CHAPAS-3), we enrolled children from one centre in Zambia and three in Uganda who were previously untreated (ART naive) or on stavudine for more than 2 years with viral load less than 50 copies per mL (ART experienced). Computer-generated randomisation tables were incorporated securely within the database. The primary endpoint was grade 2–4 clinical or grade 3/4 laboratory adverse events. Analysis was intention to treat. This trial is registered with the ISRCTN Registry number, 69078957. Findings Between Nov 8, 2010, and Dec 28, 2011, 480 children were randomised: 156 to stavudine, 159 to zidovudine, and 165 to abacavir. After two were excluded due to randomisation error, 156 children were analysed in the stavudine group, 158 in the zidovudine group, and 164 in the abacavir group, and followed for median 2·3 years (5% lost to follow-up). 365 (76%) were ART naive (median age 2·6 years vs 6·2 years in ART experienced). 917 grade 2–4 clinical or grade 3/4 laboratory adverse events (835 clinical [634 grade 2]; 40 laboratory) occurred in 104 (67%) children on stavudine, 103 (65%) on zidovudine, and 105 (64%), on abacavir (p=0·63; zidovudine vs stavudine: hazard ratio [HR] 0·99 [95% CI 0·75–1·29]; abacavir vs stavudine: HR 0·88 [0·67–1·15]). At 48 weeks, 98 (85%), 81 (80%) and 95 (81%) ART-naive children in the stavudine, zidovudine, and abacavir groups, respectively, had viral load less than 400 copies per mL (p=0·58); most ART-experienced children maintained suppression (p=1·00). Interpretation All NRTIs had low toxicity and good clinical, immunological, and virological responses. Clinical and subclinical lipodystrophy was not noted in those younger than 5 years and anaemia was no more frequent with zidovudine than with the other drugs. Absence of hypersensitivity reactions, superior resistance profi le and oncedaily dosing favours abacavir for African children, supporting WHO 2013 guidelines.en_US
dc.identifier.citationMulenga, V., Musiime, V., Kekitiinwa, A., Cook, A. D., Abongomera, G., Kenny, J., ... & CHAPAS-3 Trial Team. (2016). Abacavir, zidovudine, or stavudine as paediatric tablets for African HIV-infected children (CHAPAS-3): an open-label, parallel-group, randomised controlled trial. The Lancet Infectious Diseases, 16(2), 169-179.en_US
dc.identifier.urihttps://www.sciencedirect.com/science/article/pii/S1473309915003199
dc.identifier.urihttps://nru.uncst.go.ug/xmlui/handle/123456789/242
dc.language.isoenen_US
dc.publisherThe Lancet Infectious Diseasesen_US
dc.subjectpaediatric tabletsen_US
dc.subjectzidovudineen_US
dc.subjectHIVen_US
dc.subjectinfected childrenen_US
dc.titleAbacavir, zidovudine, or stavudine as paediatric tablets for African HIV-infected children (CHAPAS-3): an open-label, parallel-group, randomised controlled trialen_US
dc.typeArticleen_US
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