Infectious Disease, Johns Hopkins School of Medicine
Johns Hopkins University Center for Clinical Global Health Education
Hair Concentrations of Anti-Tuberculosis Drugs among HIV-Infected and Uninfected Children in India
Tuberculosis is a major cause of mortality among HIV-infected children living in the developing world. Measurement of adherence and drug levels are difficult among children, and thus we propose an innovative therapeutic drug monitoring (TDM) tool by measuring drug concentration in hair samples that estimates an average level of drug exposure over weeks to months. Since hair samples are easy and painless to collect, and can be stored and shipped at room temperature without biohazardous constraints, demonstrating the utility of this form of TDM in pediatric TB would advance the field. We hypothesize that drug concentrations INH and PZA in hair will correlate with reported adherence and plasma drug level assays in children on ATT and will be an acceptable method for TDM in India to evaluate adherence. Therefore, we are proposing to conduct a study to validate hair assay for INH and PZA and to assess the acceptability and utility of hair specimen assays for TDM and as an adherence measure among HIV-infected or uninfected children ≤ 5 years of age diagnosed with TB in India. The study will leverage and be nested within an existing NIH and Indian Council of Medical Research funded pediatric TB diagnostics study and ongoing JHU-BJ Medical College Clinical Trials Unit pediatric HIV/TB studies in Pune, India. Importantly, new collaborations will be established between TB pharmacologists at the National Institute of Research in TB (NIRT), Chennai, India and with the University of California, San Francisco where the novel hair assays for TB drug TDM have been developed.