title: Acceptability of lopinavir/r pellets (minitabs), tablets and syrups in HIV-infected children.
abstract: Lopinavir/ritonavir 'pellets' were recently tentatively approved for licensing. We describe their acceptability for infants and children up to 48 weeks.
  
  
  
  CHAPAS-2 was a randomized, two-period crossover trial comparing syrup and pellets in HIV-infected infants (n=19, group A, aged 3-<12 months) and children (n=26, group B, 1-<4 years) and tablets and pellets in older children (n=32, group C, 4-<13 years) from two clinics ('JCRC', 'PIDC') in Uganda. At week 8, all groups chose which formulation to continue. Acceptability data were collected at weeks 0, 4, 8, 12 and 48.
  
  
  
  For groups A and B overall, the proportion preferring pellets increased between week 0 and week 12 and decreased at week 48 (group A 37%, 72%, 44%; group B 12%, 64% and 36%, respectively), although there were marked differences between clinics. For group C, pellets were progressively less preferred to tablets over time: 41%, 19% and 13% at weeks 0, 12 and 48, respectively. During follow-up unpleasant taste was similarly reported among young children taking pellets and syrups (37%/43% group A; 29%/26% group B), whereas among older children, pellets tasted worse than tablets (40%/2%). No participants reported problems with storage/transportation for pellets (0%/0%) unlike syrups (23%/13%).
  
  
  
  For children <4 years, pellets were more acceptable at week 12 but not week 48. Clinic differences could reflect bias among health-care workers for different formulations. Pellets taste similar to syrup, are easier to store and transport than syrup and represent an alternative formulation for young children unable to swallow tablets; improvements in taste and support for health-care workers may help sustain acceptability.
authors.affiliation: Department of Pediatrics and Adolescent Health, Baylor College of Medicine Children's Foundation Uganda, Paediatric Infectious Diseases Clinic, Mulago Hospital Kampala, Kampala, Uganda.
authors.forename: Adeodata
authors.initials: A
authors.lastname: Kekitiinwa
authors.affiliation: Department of Paediatrics, Joint Clinical Research Centre, Kampala, Uganda.|Department of Paediatrics and Child Health, Makerere University College of Health Sciences, Kampala, Uganda.
authors.forename: Victor
authors.initials: V
authors.lastname: Musiime
authors.affiliation: Medical Research Council Clinical Trials Unit, University College London, London, UK.
authors.forename: Margaret J
authors.initials: MJ
authors.lastname: Thomason
authors.affiliation: Department of Paediatrics, Joint Clinical Research Centre, Kampala, Uganda.
authors.forename: Grace
authors.initials: G
authors.lastname: Mirembe
authors.affiliation: HCV and Paediatric HIV Program, Drugs for Neglected Diseases initiative, Geneva, Switzerland.
authors.forename: Marc
authors.initials: M
authors.lastname: Lallemant
authors.affiliation: Department of Pediatrics and Adolescent Health, Baylor College of Medicine Children's Foundation Uganda, Paediatric Infectious Diseases Clinic, Mulago Hospital Kampala, Kampala, Uganda.
authors.forename: Sarah
authors.initials: S
authors.lastname: Nakalanzi
authors.affiliation: Medical Research Council Clinical Trials Unit, University College London, London, UK.
authors.forename: David
authors.initials: D
authors.lastname: Baptiste
authors.affiliation: Medical Research Council Clinical Trials Unit, University College London, London, UK.
authors.forename: A Sarah
authors.initials: AS
authors.lastname: Walker
authors.affiliation: Medical Research Council Clinical Trials Unit, University College London, London, UK.
authors.forename: Diana M
authors.initials: DM
authors.lastname: Gibb
authors.affiliation: Medical Research Council Clinical Trials Unit, University College London, London, UK.
authors.forename: Ali
authors.initials: A
authors.lastname: Judd
mesh_terms: D019380:Anti-HIV Agents / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007223:Infant; D061466:Lopinavir / Q000008:administration & dosage*; D010342:Patient Acceptance of Health Care; D013607:Tablets; D013649:Taste; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D013607:Tablets; D061466:Lopinavir