drugset / Trial / NCT04513379

Efficacy of 400 mg Efavirenz Versus Standard 600 mg Dose in HIV/TB Co-infected Patients

NCT04513379

Phase 3 Unknown 80 enrolled Shanghai Public Health Clinical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

TB is the most common cause of death in patients with HIV worldwide. Rifampicin \[RIF\] is the cornerstone of anti-TB therapy. Current guideline recommend efavirenz (EFV) 600mg per day as the first of choice for HIV/TB co-infection. Co-administration of EFV with RIF decrease the plasma concentration of EFV. Because of better safety profiles, EFV 400mg has replaced the EFV 600mg as the first-line antiretroviral therapy in people living with HIV. However, the efficacy of EFV 400mg when co-administrated with RIF in HIV/TB co-infection is unclear. This study is designed to evaluate the efficacy and safety of EFV 400mg versus EFV 600mg in HIV/TB co-infected patients receiving RIF based anti-TB therapy.

Timeline

Start
2020-11-01
Primary completion
2022-10-30
Completion
2023-01-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Efavirenz Other / unclassified 400 mg Oral
Comparator Efavirenz Other / unclassified 600 mg Oral