Marseille 2007
| Abstract #475 - Once-a-day paediatric HAART with DDI+3TC+EFV in Burkina Faso, a phase II Trial; virology and immunologic success (ANRS 12103 trial). | ||||
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Session: 26.1: Posters B (Poster) on Tuesday in Chaired by Authors: Presenting Author: Dr Herv HIEN - Centre Muraz, Burkina Faso |
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| Additional Authors: | ||||
| Aim: Background Simplification of the administration of HAART in children should improve compliance and efficacy of these treatments. Combination of 3TC + DDI + EFV in a single daily oral administration is one of such options. However, pharmacokinetics, tolerance and efficacy of such once-a-day HAART have not been assessed in children. The ANRS 12103 trial is a phase II on virological and immunological efficacy, pharmacokinetics, tolerance and compliance of a once-a-day pediatric DDI+3TC+EFV in Burkina Faso. | ||||
| Method / Issue: ANRS 12103 is an ongoing Open Phase II Trial with a 12 months follow up. 50 HIV-1 infected children eligible for HAART should be included. Inclusion criteria are: weight 12 kg and aged 30 months to 15 years, naive of ARV treatment and eligible for HAART. HAART regime is 3TC (8mg/kg), DDI (240 mg/m2) and EFV (posology of reference). Clinical examination is performed weekly until M3, then monthly. 3TC/DDI/EFV pharmacokinetics (plasma Cmin and Cmax) is scheduled at day 15. Quaterly RNA HIV-1, CD4 counts, haematology and biochemistry are performed. | ||||
| Results / Comments: Enrolment started from February 2006, end in November 2006. 100 HIV-infected children have been screened for eligibility criteria: 47 were excluded, one died before inclusion and 52 were included. Among included children, there was 21 girls and 31 boys, means age was 6.8 years, and Zscore Weight for Age (W/A) and Height for Age (H/A) were respectively -1,91 and -1,99 at inclusion. Mean CD4 was 355/l (mean CD4 percentage: 9%), and median HIV-1 RNA was 5.5 Log10 cp/ml. Among the first 23 children tested, minimum and maximum plasma concentrations of EFV (measured by HPLC) were in the expected therapeutic ranges in 16 (70%) children, below therapeutic levels in two children (9%) and above therapeutic levels in 5 (21%). At 3 months of follow-up, one child has died, Zscore W/A and H/A were -1.57 and -2, respectively, and mean CD4 was 694/l (mean CD4 percentage: 17%). HIV-1 RNA was below detectable level (300 copies/ml) in 26/34 children (76%). At 6 months of follow-up, Zscore W/A and H/A were - 1,44 and -1,80 respectively , and mean CD4 was 738/l (mean CD4 percentage: 25%). HIV-1 RNA was below detectable level in 15/22 children (68%). One adverse effect possibly attributed to HAART was observed with a temporary stop and uneventful reintroduction of the drugs. | ||||
| Discussion: Preliminary data of this phase II trial suggest that once-a-day DDI+3TC+EFV in children provides satisfactory plasma concentration, at least for EFV, and is associated with virological success and immune restauration. At 3and 6 month follow up, once a day pediatric HAART is effective and well tolerated. | ||||
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