Volume 5 Supplement 1

Fourth Dominique International Conference. Maternal chronic viral infections transmitted to infants: from mechanisms to prevention and care

Open Access

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

  • Philippe Msellati1,
  • Boubacar Nacro2,
  • Emmanuelle Zoure2,
  • Hervé Hien3,
  • Hassane Tamboura2,
  • François Rouet3,
  • Serge Diagbouga3,
  • Adama Ouiminga3,
  • Ali Drabo3,
  • Souleymane Yaméogo3,
  • Hélène Peyrière4,
  • Olivier Mathieu4,
  • Joëlle Nicolas4 and
  • Philippe Van de Perre4
Retrovirology20085(Suppl 1):O26

DOI: 10.1186/1742-4690-5-S1-O26

Published: 9 April 2008

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.

Authors’ Affiliations

(1)
UMR 145 IRD, Bobo-Dioulasso
(2)
Department of Pediatrics, CHU de Bobo-Dioulasso
(3)
Centre Muraz, Bobo-Dioulasso
(4)
Laboratory of Medical Pharmacology and Laboratory of Virology, Montpellier University Hospital

Copyright

© Msellati et al.; licensee BioMed Central Ltd. 2008

This article is published under license to BioMed Central Ltd.

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