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Call Career Development Fellowship (CDF)
Programme EDCTP2
Start Date 2018-06-01
End Date 2021-05-31
Project Code TMA2016CDF1580
Status Completed

Title

Safety and Efficacy of High Dose Rifampicin in TB-HIV co-infected patients on Efavirenz-based Antiretroviral therapy

Objectives

Primary objective 1. To determine the effect of a high dose of rifampicin (35 mg/kg orally) on the pharmacokinetics of first-line antiretroviral drugs (efavirenz and dolutegravir) in TB-HIV co-infected patients on TB treatment. Secondary objectives 1. To investigate the safety/tolerability of a high dose of rifampicin in TB-HIV co-infected patients on TB treatment and first-line antiretroviral therapies. 2. To determine if TB-HIV co-infected patients on a high dose of rifampicin are more likely to have negative sputum cultures by the end of the intensive phase of TB treatment than patients on standard-dose rifampicin. 3. To explore the relationships between exposure to rifampicin, efavirenz and dolutegravir and the tolerability and efficacy of these drugs.

Host Organisation

Institution Country
Makerere University - IDI Uganda

Study Design

Randomized four-arm open label clinical trial (Phase IIb) High dose rifampicin will be administered for the first 8 weeks (intensive phase) of TB treatment. All other anti-TB drugs will be administered at the standard dose using fixed-dose combinations (FDC). All participants will receive standard dose rifampicin during the continuation phase (weeks 9 -24)

Phd Study

Title University Start Date End Date
Correlating rifampcin and isoniazid concentrations with treatment outcomes in TB/HIV co-infected patients Makerere University/University of Zurich 2015-07-15 2019-05-05

Results & Outcomes

Sub-therapeutic rifampicin and isoniazid concentrations in up to 84% of population which was associated with delayed sputum conversion No association between drug concentrations and sputum smear conversion is not surprising Efavirenz associated with 20% increase in isoniazid clearance

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