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Once-a-day pediatric HAART with DDI+3TC+EFV in Burkina Faso. A phase II trial (ANRS 12103 trial)

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 option. 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 pharmacokinetics, tolerance and compliance of a once-a-day pediatric DDI+3TC+EFV in Burkina Faso.

Material and methods

ANRS 12103 is an ongoing Open Phase II Trial with a 12 months follow up. 50 HIV-1 infected children eligible for HAART had to be included. Inclusion criteria were: weight ≥ 10 kg and aged 30 months to 15 years, naive of ARV treatment and eligible for HAART. Children received efavirenz + 3TC (8mg/kg) + DDI (240mg/m2). Clinical examination was performed weekly until M3, then monthly. Pharmacokinetics (plasma Cmin and Cmax) was done at day 15. Quaterly RNA HIV-1, CD4 counts, haematology and biochemistry are performed.

Results

Enrolment was from February to November 2006 and 98 HIV-infected children have been screened for eligibility criteria: 45 were excluded, one died before inclusion and 52 were included. Among included children there was 21 girls and 31 boys, mean age was 6.8 years, 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/µl (mean CD4 percentage 9%), and median HIV-1 RNA 5.50 Log10 cp/ml. Among the 52 expected samples for minimum concentration of efavirenz, 50 were obtained. Thirty children were in the expected ranges (60.1%), 11 (22%) below therapeutic levels and 9 (18%) above therapeutic levels. Maximum concentrations were in the expected ranges in 23/49 children (47%), below therapeutic levels in 3/49 children (6%) and over in 23/49 children. Dosages of 3TC and DDI are ongoing.

At 9 months of follow-up, two children had died, Zscore W/A and H/A were respectively -1.37 and -1.62, and mean CD4 was 893/µl (mean CD4 percentage 20%). HIV-1 RNA was below detectable level (300 copies/ml) in 39 children (76%) and below 1000 copies/ml in two children (4%).Two HAART adverse effect occurred. One cutaneous eruption with a temporary stop and successful reintroduction and one increase in liver enzymes.

Conclusion

Preliminary data of this phase II trial suggest that once-a-day DDI+3TC+EFV in children provides satisfactory plasma concentration for EFV, and is associated with virological success and immune restoration. At 9-month follow up, it is effective and well tolerated.

Author information

Correspondence to Philippe Msellati.

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Open Access This article is published under license to BioMed Central Ltd. This is an Open Access article is distributed under the terms of the Creative Commons Attribution 2.0 International License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Msellati, P., Nacro, B., Zoure, E. et al. Once-a-day pediatric HAART with DDI+3TC+EFV in Burkina Faso. A phase II trial (ANRS 12103 trial). Retrovirology 5, O26 (2008). https://doi.org/10.1186/1742-4690-5-S1-O26

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Keywords

  • Efavirenz
  • Minimum Concentration
  • Infected Child
  • Therapeutic Level
  • Open Phase