Plasma pharmacokinetic study of once versus twice daily abacavir as part of combination antiretroviral therapy in children with human immunodeficiency virus-1 infection aged 3 months to <36 months
Can some anti-HIV drugs be given to very young children once a day instead of twice a day?
What was this study about?
PENTA 15 was a study involving young children. It aimed to examine the level of the anti-HIV drug abacavir (and lamivudine if this drug was also being taken) in the blood, to see whether levels remain similar when this medicine is taken once a day rather than twice a day.
This study also investigated whether it is easier for families to remember to give children their medicines once a day rather than twice a day.
What difference did this study make?
The results of PENTA 15 suggested that taking antiretrovirals (abacavir and lamivudine) once daily is equivalent to taking them twice daily in young children.
The results did not show any evidence that taking antiretrovirals once daily increased toxicity, or that it decreased the efficacy of the treatment.
These findings from the PENTA 15 trial are consistent with those from PENTA 13. These results provide support for the option of once daily regimens for children infected with HIV.
Data from PENTA 13, PENTA 15 and the ARROW trial were included in a submission to the US Food and Drug Administration and the European Medicines Agency for licensing of once daily dosing of the drugs 3TC and abacavir. Based on the data, both agencies have now approved this change.
Type of study
Who funded the study?
PENTA 15 was funded by an organisation called PENTA, which is mainly funded by the European Commission. This trial was also supported by GlaxoSmithKline.
When did it take place?
Recruitment was completed in 2008. All children have completed 48 weeks follow-up.
Where did it take place?
This study recruited patients in France, Germany, Italy, Spain, and the UK.
Who was included?
Children who have HIV infection and were between the ages of 3 months and 3 years of age. To be eligible to enter the trial, children must have been taking abacavir for 12 weeks or more and were benefiting from their current treatment by maintaining a low level of the HIV virus in the blood.