Pharmacokinetics of Efavirenz in the Presence of Rifampicin and Isoniazid
Status:
Unknown status
Trial end date:
2018-02-01
Target enrollment:
Participant gender:
Summary
The purpose of the study is to measure the drug levels in the blood of HIV-infected
individuals taking anti- HIV medication efavirenz 400 mg once daily in the presence of
anti-TB medication rifampicin and isoniazid. The study is being run in two-stages - London
(Stage 1) and Kampala (Stage 2).
In London (Stage 1): HIV-1 infected patients (without tuberculosis infection) on established
treatment with a combination based on 600 mg efavirenz dose will be recruited.
In Kampala (Stage 2): Patients with both HIV-1 and tuberculosis infection being treated with
600 mg efavirenz combination for HIV AND undergoing TB treatment with a dual therapy regimen
contaning rifampicin and isoniazid will be recruited.
Efavirenz-containing regimens are recommended as first-line therapy for HIV-TB co-infected
patients. It has been shown there is a 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
Phase:
Phase 1
Details
Lead Sponsor:
St Stephens Aids Trust
Collaborators:
Mylan Inc. United States Agency for International Development (USAID)