title: Isoniazid preventive therapy in HIV-infected children on antiretroviral therapy: a pilot study.
abstract: METHODS
  Tuberculosis (TB) is a common cause of mortality and morbidity in children infected with the human immunodeficiency virus (HIV). Data on isoniazid preventive therapy (IPT) efficacy in HIV-infected children receiving antiretroviral therapy (ART) are inconclusive.
  
  
  OBJECTIVE
  To assess the efficacy, tolerability and safety of isoniazid (INH) in HIV-infected children on ART.
  
  
  METHODS
  A pilot randomised controlled study of INH was undertaken in HIV-infected children on ART. The primary outcome measure was TB disease or death.
  
  
  RESULTS
  A total of 167 children were randomised to receive INH (n = 85) or placebo (n = 82), and followed for a median of 34 months (interquartile range [IQR] 24-52). The median age was 35 months (IQR 15-65). There was one death in a child on INH and none in the placebo group. Eleven (6.6%) cases of TB occurred, 4 (5%) in the INH and 7 (9%) in the placebo group. Among the TB cases, 5 were culture confirmed-2 in the INH group and 3 in the placebo group, all susceptible to INH. Severe adverse events occurred rarely (n = 6; 2%).
  
  
  CONCLUSIONS
  IPT is safe and well tolerated in HIV-infected children on concomitant ART. This study supports the need for a larger study to assess efficacy in HIV-infected children living in TB-endemic areas.
authors.affiliation: Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, University of Cape Town, Cape Town, South Africa.
authors.forename: D M
authors.initials: DM
authors.lastname: Gray
authors.affiliation: Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, University of Cape Town, Cape Town, South Africa.
authors.forename: L J
authors.initials: LJ
authors.lastname: Workman
authors.affiliation: Biostatistics Unit, Medical Research Council, Cape Town, South Africa.
authors.forename: C J
authors.initials: CJ
authors.lastname: Lombard
authors.affiliation: Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, University of Cape Town, Cape Town, South Africa.
authors.forename: T
authors.initials: T
authors.lastname: Jennings
authors.affiliation: Department of Paediatrics and Child Health, Stellenbosch University, Stellenbosch, South Africa.
authors.forename: S
authors.initials: S
authors.lastname: Innes
authors.affiliation: Anova Health Institute, TC Newman Hospital, Paarl, South Africa.
authors.forename: C J
authors.initials: CJ
authors.lastname: Grobbelaar
authors.affiliation: Department of Paediatrics and Child Health, Stellenbosch University, Stellenbosch, South Africa.
authors.forename: M F
authors.initials: MF
authors.lastname: Cotton
authors.affiliation: Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, University of Cape Town, Cape Town, South Africa.
authors.forename: H J
authors.initials: HJ
authors.lastname: Zar
mesh_terms: D000367:Age Factors; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D000995:Antitubercular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D046688:Child Mortality; D002675:Child, Preschool; D060085:Coinfection; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D007538:Isoniazid / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies; D013019:South Africa / Q000453:epidemiology; D013997:Time Factors; D016896:Treatment Outcome; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis / Q000401:mortality / Q000517:prevention & control*
chemical_list: D019380:Anti-HIV Agents; D000995:Antitubercular Agents; D007538:Isoniazid