Nevirapine Drug Levels in HIV Positive Patients Also Receiving Rifampicin for Tuberculosis
Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
Participant gender:
Summary
Triomune is the most commonly prescribed treatment for HIV infection in Uganda. Triomune is
manufactured by a generic drug company and consists of three drugs combined in a single pill
given twice daily (stavudine 30mg plus lamivudine 150mg plus nevirapine 200mg).
It is known that the levels of nevirapine in a patient's blood are highest in the first two
weeks of treatment. Therefore it is recommended that patients starting on nevirapine should
undergo dose escalation i.e start on 200mg once daily for two weeks and then increase to full
dose of 200mg twice daily in order to avoid nevirapine related rash. It is not possible to do
dose escalation with a fixed dose combination pill like Triomune and for the two weeks of the
dose escalation patients either can buy stavudine plus lamivudine plus nevirapine as separate
pills or take Triomune in the morning and then take stavudine plus lamivudine as separate
pills in the evening.
Rifampicin is used to treat TB and lowers the levels of nevirapine in a patient's blood. This
raises two questions in routine clinical practice for patients who are co-infected with HIV
and TB (1) Do we need to put our patients to the trouble of dose escalation of nevirapine if
they are already on rifampicin? and (2) If we dose escalate nevirapine in patients on
rifampicin, are we putting them at risk of low drug levels and development of resistance? The
aim of this study is to compare the plasma concentrations of nevirapine in HIV infected
patients who are commencing antiretroviral therapy with and without a lead in dose of
nevirapine and who are also receiving concomitant treatment with antituberculous therapy
which includes rifampicin to assess whether dose escalation of nevirapine is appropriate in
this patient population