drugset / Trial / NCT04513379
Efficacy of 400 mg Efavirenz Versus Standard 600 mg Dose in HIV/TB Co-infected Patients
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Efavirenz | Other / unclassified | 400 mg | Oral |
| Comparator | Efavirenz | Other / unclassified | 600 mg | Oral |