title: Detecting virological failure in HIV-infected Tanzanian children.
abstract: BACKGROUND
  The performance of clinical and immunological criteria to predict virological failure in HIV-infected children receiving antiretroviral therapy (ART) is not well documented.
  
  
  OBJECTIVE
  To determine the validity of clinical and immunological monitoring in detecting virological failure in children on ART.
  
  
  METHODS
  A total of 218 children were included in the study. All were from care and treatment clinics in Dar es Salaam, Tanzania. Their mean age was 10.6 years, 122 (56.0%) were males, and the mean time on ART was 40.9 months. The study was conducted from August 2011 to March 2012. Data on sociodemographic and clinical characteristics and immunological and virological failure were based on World Health Organization definitions. Blood samples were collected for CD4+ T-cell count and viral load tests.
  
  
  RESULTS
  Of 217 children with available viral load results, 124 (57.1%) had virological failure (>400 copies/mL), 25.0% immunological failure and 11.5% clinical failure. The sensitivity, specificity, positive predictive value and negative predictive value of clinical criteria were 12.9%, 90.3%, 64.0% and 43.8%, respectively, those for immunological criteria 22.6%, 73.1%, 53.3% and 41.4%, and those for the combination of clinical and immunological monitoring 25.8%, 69.9%, 53.3% and 41.4%. Children who received nevirapine (NVP)-based regimens were two times more likely (odds ratio 2.0; 95% confidence interval 1.20 - 3.64) to have virological failure than those on efavirenz and protease inhibitor-based regimens.
  
  
  CONCLUSIONS
  The study demonstrated poor performance of currently recommended clinical and immunological criteria for monitoring HIV-infected children on ART. Moreover, children on NVP-based regimens had a higher risk of developing virological failure than those on other regimens.
authors.affiliation: Department of Paediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania. drmgelea@gmail.com.
authors.forename: Edward Machage
authors.initials: EM
authors.lastname: Mgelea
authors.forename: R
authors.initials: R
authors.lastname: Kisenge
authors.forename: S
authors.initials: S
authors.lastname: Aboud
mesh_terms: D000480:Alkynes; D044966:Anti-Retroviral Agents / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods / Q000706:statistics & numerical data; D048588:Benzoxazines / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D002648:Child; D003430:Cross-Sectional Studies; D003521:Cyclopropanes; D016903:Drug Monitoring / Q000379:methods / Q000706:statistics & numerical data; D024921:Drug Resistance, Multiple, Viral; D005188:False Negative Reactions; D005189:False Positive Reactions; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000453:epidemiology / Q000276:immunology / Q000821:virology; D006801:Humans; D008297:Male; D015166:Monitoring, Immunologic / Q000379:methods / Q000706:statistics & numerical data; D019829:Nevirapine / Q000627:therapeutic use*; D011237:Predictive Value of Tests; D013636:Tanzania / Q000453:epidemiology; D017211:Treatment Failure; D019562:Viral Load / Q000187:drug effects
chemical_list: D000480:Alkynes; D044966:Anti-Retroviral Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D019829:Nevirapine; C098320:efavirenz