SSAT062 - PK of EFV 400mg once daily in presence of RIF/INH
Research type
Research Study
Full title
Steady-state pharmacokinetics of efavirenz (Sustiva/Stocrin) 400 mg once daily in the presence of rifampicin and isoniazid (Rifinah or the local generics)
IRAS ID
161311
Contact name
Marta Boffito
Contact email
Sponsor organisation
St Stephen's AIDS Trust
Eudract number
2014-002608-26
Duration of Study in the UK
0 years, 9 months, 17 days
Research summary
The ENCORE-1 study showed the lack of a significant difference between efavirenz 400 mg and efavirenz 600 mg, indicating that 400 mg efavirenz is non-inferior to the standard dose.
The advantages of antiretroviral dose reductions may translate into greater benefits for more individuals infected by HIV globally, since they may allow access programs to reach higher numbers of infected patients and compensate for the finite global manufacturing capacity and increasing demand. For efavirenz, significant price reductions have been achieved through elimination of trade, logistics and manufacturing capacity barriers, and further price reductions could be achieved with a significant reduction in the cost of pharmaceutical ingredients. However, no data on the PK and effectiveness of efavirenz 400 mg once daily during TB treatment has been produced. Given that many patients on Efavirenz- based ART will need to be treated for TB during their lifetime and rifampicin is one of the most commonly used treatment for tuberculosis, it is important to study the reduced dose under carefully monitored conditions prior to roll out of a lower dose standard treatment. Therefore, we aim to investigate the PK of efavirenz 400 mg once daily in HIV-infected individuals in the presence of rifampicin and isoniazid in London, UK and in HIV/TB-co-infected individuals on dual anti-TB treatment in Kampala, Uganda.REC name
London - Central Research Ethics Committee
REC reference
16/LO/1357
Date of REC Opinion
15 Sep 2016
REC opinion
Further Information Favourable Opinion