Pharmacology and immuno-virologic efficacy of once-a-day HAART in African HIV-infected children: ANRS 12103 phase II trial

• Main Authors: Boubacar Nacro (Author), Emmanuelle Zoure (Author), Hervé Hien (Author), Hassane Tamboura (Author), François Rouet (Author), Adama Ouiminga (Author), Ali Drabo (Author), Souleymane Yameogo (Author), Alain Hien (Author), Hélène Peyriere (Author), Olivier Mathieu (Author), Deborah Hirt (Author), Jean-Marc Treluyer (Author), Joëlle Nicolas (Author), Vincent Foulongne (Author), Michel Segondy (Author), Philippe van de Perre (Author), Serge Diagbouga (Author), Philippe Msellati (Author)
• Format: Book
• Published: The World Health Organization, 2011-06-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Summary

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. FINDINGS: 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 log10 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%). CONCLUSION: 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.

Item Description

0042-9686
10.2471/BLT.10.081646