To compare the plasma pharmacokinetic (PK) parameters of q24h versus q12h dosing of abacavir in HIV-1-infected infants and children aged 3 months to 36 months The secondary objectives of PENTA15 were: To compare the plasma PK parameters of q24h versus q12h dosing of lamivudine in HIV-1-infected infants and children aged 3 months to 36 months who were receiving lamivudine in combination with abacavir To compare age-related differences in the PK parameters of q24h versus q12h dosing of abacavir and lamivudine infants and children in 3 age groups (≥3 to \<12 months, ≥12 to \<24 months and ≥24 to \<36 months) To describe child and family acceptability of and adherence to q24h compared to q12h dosage regimens of abacavir and lamivudine
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Week 0
Hôpital Port Royal
Paris, France
Hôpital Robert Debré
Paris, France
Immundefekt-Ambulanz, Dr. von Haunersches Kinderspital
Munich, Germany
Clinica Pediatrica, Università di Padova
Padua, Italy
Hospital Universitario
Getafe, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Gregorio Maranon
Madrid, Spain
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Evelina Children's Hospital
London, United Kingdom
St. Mary's Hospital
London, United Kingdom
Area Under Curve (AUC) (0-24) of Abacavir on Twice Daily Dosing
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.
Time frame: Week 0
Cmax of Abacavir on Twice Daily Dosing
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.
Time frame: Week 0
AUC(0-24) of Abacavir on Once Daily Dosing
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication
Time frame: Week 4
Cmax of Abacavir on Once Daily Dosing
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication.
Time frame: Week 4
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