Cohort profile of a study on outcomes related to tuberculosis and antiretroviral drug concentrations in Uganda: design, methods and patient characteristics of the SOUTH study
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Date
2017
Journal Title
Journal ISSN
Volume Title
Publisher
BMJ open
Abstract
Tuberculosis (TB) is a leading cause of death
among people living with HIV in sub-Saharan Africa.
Several factors influence the efficacy of TB treatment
by leading to suboptimal drug concentrations and
subsequently affecting treatment outcome. The aim of this
cohort is to determine the association between anti-TB
drug concentrations and TB treatment outcomes.
Participants Patients diagnosed with new pulmonary
TB at the integrated TB-HIV outpatient clinic in Kampala,
Uganda, were enrolled into the study and started on firstline
anti-TB treatment.
Findings to date Between April 2013 and April 2015,
the cohort enrolled 268 patients coinfected with TB/HIV
; 57.8% are male with a median age of 34 years (IQR
29–40). The median time between the diagnosis of HIV and
the diagnosis of TB is 2 months (IQR 0–22.5). The majority
of the patients are antiretroviral therapy naive (75.4%). Our
population is severely immunosuppressed with a median
CD4 cell count at enrolment of 163 cells/μL (IQR 46–298).
Ninety-nine per cent of the patients had a diagnosis of
pulmonary TB confirmed by sputum microscopy, Xpert/RIF
or culture and 203 (75.7%) have completed TB treatment
with 5099 aliquots of blood collected for pharmacokinetic
analysis.
Future plans This cohort provides a large database of
well-characterised patients coinfected with TB/HIV which
will facilitate the description of the association between
serum drug concentrations and TB treatment outcomes as
well as provide a research platform for future substudies
including evaluation of virological outcomes.
Description
Keywords
Cohort profile, Tuberculosis, Antiretroviral drug concentrations, Design
Citation
Sekaggya-Wiltshire C, Castelnuovo B, von Braun A, et al. Cohort profile of a study on outcomes related to tuberculosis and antiretroviral drug concentrations in Uganda: design, methods and patient characteristics of the SOUTH study. BMJ Open 2017;7:e014679. doi:10.1136/ bmjopen-2016-014679