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Once-a-day pediatric HAART with DDI+3TC+EFV in Burkina Faso - a phase II Trial (ANRS 12103 trial)
Presented by Philippe Msellati, France.
P. Msellati1, B. Nacro2, E. Zoure2, H. Hien3, H. Tamboura4, F. Rouet3, S. Diagbouga3, A. Ouiminga3, A. Drabo3, S. Yameogo5, H. Peyriere6, O. Mathieu6, J. Nicolas7, P. Van de Perre8
1IRD, CReCSS, UMR 145, Aix en Provence, France, 2CHU Bobo-Dioulasso, Department of Pediatrics, Bobo Dioulasso, Burkina Faso, 3Centre Muraz, Bobo-Dioulasso, Burkina Faso, 4CHU Bobo-Dioulasso, Department of Pediatrics, Bobo-Dioulasso, Burkina Faso, 5CHU Bobo-Dioulasso, Pharmacie, Bobo-Dioulasso, Burkina Faso, 6Montpellier University Hospital, Laboratory of Medical Pharmacology, Montpellier, France, 7Montpellier University Hospital, Department of Paediatrics, Montpellier, France, 8Montpellier University Hospital, Laboratory of Virology, 5 EA 4205 'Transmission, pathogenesis and prevention of HIV', Montpellier, France
Background: The ANRS 12103 trial is a phase II on pharmacokinetics, tolerance and compliance of a once-a-day paediatric 3TC + DDI + EFV in Burkina Faso.
Methods: Open Phase II Trial. HIV-1 infected children eligible for HAART recruited. Inclusion criteria were: weight ³ 10 kg, aged 30 months to 15 years, and naive of ARV treatment. Children received 3TC (8mg/kg) + DDI (240mg/m2) + EFV. Clinical examination was performed monthly, pharmacokinetics (plasma Cmin and Cmax) at day 15 and HIV-1 RNA, CD4 counts, haematology and biochemistry quaterly.
Results: Enrolment February - November 2006 : 98 HIV-infected children screened, 45 were excluded, one died before inclusion. Among the 52 included children, 21 girls/31 boys, mean age was 6.8 years, Z score Weight for Age (W/A) and Height for Age (H/A) were respectively -1.91 and -1.99 at inclusion. Mean CD4 was 355/µl (mean percentage 9%), and median HIV-1 RNA 5.50 Log10 cp/ml. 50 samples were obtained for pharmacokinetics of EFV. For minimum concentrations, 30 children (60%) were in the expected ranges, 11 (22%) below therapeutic levels and 9 (18%) above. Maximum concentrations were in the expected ranges in 23/49 children (47%), below therapeutic levels in 3/49 (6%) and over in 23. Dosages of 3TC and DDI are pending. At 12 months of follow-up, 2 children had died, Z score W/A and H/A were respectively -1.5 and -1.69, and mean CD4 811/µl (mean percentage 23%). HIV-1 RNA was below detectable level in 38/49 children (78%) and <1000 copies/ml in 39/49(80%).Two HAART-related adverse effects occurred: one cutaneous eruption and one increase in liver enzymes.
Conclusions: Preliminary data of this phase II trial suggest that once-a-day 3TC + DDI + EFV in children provides satisfactory plasma concentration for EFV, and is associated with virological success and immune reconstitution
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