Efavirenz-based Versus Nevirapine-based Antiretroviral Therapy Among HIV-infected Patients Receiving Rifampin
Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
Participant gender:
Summary
The randomized controlled trial is conducted among antiretroviral naive co-infected HIV and
tuberculosis patients who receiving rifampicin-based antituberculous regimen fro at least 4
weeks butt not exceed 16 weeks before enrolment. All patients receive the same backbone
regimen of stavudine (30 mg/40 mg twice daily)+ lamivudie 150 mg twice daily. They are
randomized to receive nevirapine 400 mg/day twice daily vs efavirenz 600 mg/day at bed time.
All patients are followed through 144 weeks after initiation of antiviral therapy. The
primary objective are to compare the proportion of patient who achieve undetectable plasma
HIV-1RNA<50 copies/ml at week 48. The previous reports demonstrated that the standard doses
of both nevirapine and efavirenz coulde be used among co-infected HIV and tuberculosis
patients who receiving rifampicin even though plasma levels are somewhat reduced by
rifampicin. However, there have been not been a randomized control trial to compare these two
regimens. Thus, this trial will provide the efficacy data between these two regimens.