PENTA 15: 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 is this study about?
PENTA 15 is a study involving young children. It aims to examine the level of the anti-HIV drug abacavir (and lamivudine if this drug is 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 will also investigate whether it is easier for families to remember to give children their medicines once a day rather than twice a day.
Who is included?
Children who have HIV infection and are 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 should be benefiting from their current treatment by maintaining a low level of the HIV virus in the blood.
When is it taking place?
Recruitment was completed in 2008. All children have completed 48 weeks follow-up.
Where is it taking place?
This study recruited patients in France, Germany, Italy, Spain, and the UK.
Who is funding the study?
PENTA 15 is funded by an organisation called PENTA, which is mainly funded by the European Commission. This trial is being supported by GlaxoSmithKline.
|Type of study:||Non-randomised trial|
|Study start date:||Jun-06|
|Study end date:||Apr-08|
|Registrations achieved:||10, as of September 2007|
|Also included in this study:|
Quality of life outcomes
|Chief investigator:||Dr. David Burger|
|Inclusion criteria:||1. Infants and children with confirmed presence of HIV-1 infection (see CDC definition, Appendix 7). 2. Infants and children aged 3 to <36 months. 3. Parents/guardians able and willing to give written, informed consent. 4. Currently on combination ART including ABC oral solution with or without 3TC oral solution, for at least 12 weeks and expected to stay on this regimen for at least a further 12 weeks. 5. HIV-1 RNA viral load either; suppressed HIV-1 RNA viral load (i.e. <400 copies/ml) or non-suppressed, but low, HIV-1 RNA viral load (i.e. 400-20 000 copies/ml). The non-suppressed children should have had a stable or decreasing HIV-1 RNA viral load prior to study entry and should be considered to be still gaining benefit from the current regimen. 6. Stable or rising CD4+ cell percent prior to study entry and should not be expected to fall within the next 12 weeks. |
|Exclusion criteria:||1. Intercurrent illness 2. Receiving concomitant therapy except prophylactic antibiotics 3. Abnormal renal or liver function (grade 3 or above)|
|Intervention and control groups:||Antiretroviral therapy|
|Method of randomisation:||n/a|
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