title: Pharmacology and immuno-virologic efficacy of once-a-day HAART in African HIV-infected children: ANRS 12103 phase II trial.
abstract: OBJECTIVE
  To assess 12-month survival, pharmacokinetics, immunologic and virologic efficacy, tolerance, compliance and drug resistance in HIV-infected children in Bobo-Dioulasso, Burkina Faso, receiving once-daily highly-active antiretroviral therapy as a combination of didanosine (DDI), lamivudine (3TC) and efavirenz (EFV).
  
  
  METHODS
  In the ANRS 12103 open phase II trial, HIV-infected children were examined at inclusion and monthly thereafter. CD4+ T-lymphocyte (CD4) count, plasma concentration of ribonucleic acid (RNA) of human immunodeficiency virus type 1 (HIV-1) and haematologic and biochemical parameters were measured at baseline and every trimester. HIV-1 resistance testing was performed in case of viral escape. Drug plasma concentrations were determined with high-performance liquid chromatography.
  
  
  RESULTS
  From February 2006 to November 2007, 51 children (39% girls) with a mean age of 6.8 years were enrolled and treated for 12 months. At baseline, Z scores for mean weight-for-age and mean height-for-age were -2.01 and -2.12, respectively. Mean CD4% was 9.0. Median plasma HIV-1 RNA viral load was 5.51 log(10) copies per millilitre (cp/ml). Two children (3.9%) died and another 11 (22%) suffered 13 severe clinical events. At month 12, mean WAZ had improved by 0.63 (P < 0.001) and mean HAZ by 0.57 (P < 0.001). Mean CD4% had risen to 24 (P < 0.001). Viral load was below 300 RNA cp/ml in 81% of the children; HIV resistance mutations were detected in 11 (21.6%).
  
  
  CONCLUSIONS
  The once-a-day combination of DDI + 3TC + EFV is an alternative first-line treatment for HIV-1-infected children. Dose adjustment should further improve efficacy.
authors.affiliation: Department of Paediatrics, Centre hospitalier universitaire Souro Sanou, Bobo-Dioulasso, Burkina Faso.
authors.forename: Boubacar
authors.initials: B
authors.lastname: Nacro
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Zoure
authors.forename: Hervé
authors.initials: H
authors.lastname: Hien
authors.forename: Hassane
authors.initials: H
authors.lastname: Tamboura
authors.forename: François
authors.initials: F
authors.lastname: Rouet
authors.forename: Adama
authors.initials: A
authors.lastname: Ouiminga
authors.forename: Ali
authors.initials: A
authors.lastname: Drabo
authors.forename: Souleymane
authors.initials: S
authors.lastname: Yameogo
authors.forename: Alain
authors.initials: A
authors.lastname: Hien
authors.forename: Hélène
authors.initials: H
authors.lastname: Peyriere
authors.forename: Olivier
authors.initials: O
authors.lastname: Mathieu
authors.forename: Deborah
authors.initials: D
authors.lastname: Hirt
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Treluyer
authors.forename: Joëlle
authors.initials: J
authors.lastname: Nicolas
authors.forename: Vincent
authors.initials: V
authors.lastname: Foulongne
authors.forename: Michel
authors.initials: M
authors.lastname: Segondy
authors.forename: Philippe
authors.initials: P
authors.lastname: van de Perre
authors.forename: Serge
authors.initials: S
authors.lastname: Diagbouga
authors.forename: Philippe
authors.initials: P
authors.lastname: Msellati
mesh_terms: D000293:Adolescent; D000349:Africa / Q000453:epidemiology; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000494:pharmacology* / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D019540:Area Under Curve; D002050:Burkina Faso / Q000453:epidemiology; D018791:CD4 Lymphocyte Count; D002648:Child; D002675:Child, Preschool; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000401:mortality; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D008297:Male; D016019:Survival Analysis
chemical_list: D019380:Anti-HIV Agents