Nevirapine Drug Levels in HIV Positive Patients Also Receiving Rifampicin for Tuberculosis

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Makerere University
• Collaborator: University of Liverpool
• Treatments: Nevirapine; Rifampin

Criteria

Inclusion Criteria:

• Ability to provide full informed written consent

• Confirmed diagnosis of HIV infection

• On rifampicin therapy for at least two weeks

• Clinical criteria for commencing antiretroviral therapy

Exclusion Criteria:

• Hemoglobin < 8g/dl

• Liver and renal function tests > 3 times the upper limit of normal

• Pregnancy

• Use of know inhibitors or inducers of Cytochrome P450 or P-glycoprotein.

• Use of herbal medications

• Intercurrent Illness