Isoniazid preventive therapy in HIV-infected children on antiretroviral therapy: a pilot study

Int J Tuberc Lung Dis. 2014 Mar;18(3):322-7. doi: 10.5588/ijtld.13.0354.


Setting: 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.

Design: 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%).

Conclusion: 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.

Trial registration: NCT00330304.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Age Factors
  • Anti-HIV Agents / therapeutic use*
  • Antitubercular Agents / adverse effects
  • Antitubercular Agents / therapeutic use*
  • Child Mortality
  • Child, Preschool
  • Coinfection*
  • Double-Blind Method
  • Female
  • HIV Infections / diagnosis
  • HIV Infections / drug therapy*
  • HIV Infections / mortality
  • Humans
  • Infant
  • Infant Mortality
  • Isoniazid / adverse effects
  • Isoniazid / therapeutic use*
  • Male
  • Pilot Projects
  • Prospective Studies
  • South Africa / epidemiology
  • Time Factors
  • Treatment Outcome
  • Tuberculosis, Pulmonary / diagnosis
  • Tuberculosis, Pulmonary / mortality
  • Tuberculosis, Pulmonary / prevention & control*


  • Anti-HIV Agents
  • Antitubercular Agents
  • Isoniazid

Associated data