NCT00483054

Efavirenz-based Versus Nevirapine-based Antiretroviral Therapy Among HIV-infected Patients Receiving Rifampin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Bamrasnaradura Infectious Diseases Institute · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections
• Tuberculosis

Interventions

Type	Name	Description
DRUG	efavirenz	efavirenz 600 mg/day + stavudine + lamivudine
DRUG	nevirapine	nevirapine 400 mg/day + stavudine +lamivudine

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-12-01
• Completion: 2010-12-01
• First posted: 2007-06-06
• Last updated: 2011-11-22

Locations

1 site across 1 country: Thailand