17th International AIDS Conference Mexico City, Mexico - August 13 - 18, 2008

ONCE-A-DAY PEDIATRIC HAART WITH DDI+3TC+EFV IN BURKINA FASO - A PHASE II TRIAL (ANRS 12103 TRIAL)

Int Conf AIDS. 2008 Aug 13-18;17 Abstract No. MoAb0105

P. Msellati ¹, 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 Perre^8
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 ≥10 kg, aged 30 months to 15 years, and naïve of ARV treatment. Children received 3TC (8 mg/kg) + DDI (240 mg/m²) + EFV. Clinical examination was performed monthly, pharmacokinetics (plasma C_min and C_max) 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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2008-08-13
MoAb0105

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