Correlating anti-TB drug pharmacokinetics with clinical outcomes in TB/HIV co-infected patients
“SOUTH” is an ongoing study on the evaluation of the pharmacokinetics of anti-tuberculosis (TB) drugs and TB treatment outcomes in HIV/TB co-infected Ugandan adults. Worldwide this is one of the largest prospective trial looking into this topic. It has the potential to answer a number of burning research questions related to TB.
The main aim of this study is to determine the association between anti-TB drug concentration s and sputum smear and culture conversion in TB/HIV co-infected patients in Uganda . This study is currently ongoing in Kampala where patients diagnosed with TB are initiated on the standard TB treatment and followed up in the TB clinic at the Infectious Diseases Institute (IDI).
During the exchange visit in Zurich, data analysis will be done to determine the serum concentrations of anti-TB drugs in the Ugandan population and to correlate these concentrations with treatment outcomes.
The objectives of the proposed study are:
1. To investigate the association between the pharmacokinetic (PK) parameters of isoniazid and rifam picin and time to sputum smear conversion in TB/HIV co-infected individuals.
2. To investigate the association between the PK parameters of isoniazid and rifampicin and time to sputum culture conversion in TB/HIV co-infected individuals.
3. To assess the relationship between the liver safety parameters, peripheral neuropathy and PK parameters of isoniazid and rifampicin at different time points during the course of tuberculosis treatment in TB/HIV co-infected individuals.
4. To determine the pharmacokinetic predictors of mortality at 12 months in TB/HIV co infected individuals.
5. To investigate the association between the pharmacokinetic parameters of isoniazid and rifampicin and radiological changes in TB/HIV co-infected individuals.
–Dr Fehr Jan, Male Swiss University Hospital of Zurich (USZ)
–Christine Sekaggy, Infectious Diseases Institute, Makerere University, Kampala, Uganda