NCT04513379

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

Efficacy and Safety of 400 mg Efavirenz Versus Standard 600 mg Dose in HIV/TB Co-infected Patients Receiving Rifampicin Based Anti-TB Therapy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Shanghai Public Health Clinical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections
• Tuberculosis

Interventions

Type	Name	Description
DRUG	Efavirenz 600mg	EFV 600 mg per day given orally
DRUG	Efavirenz 400mg	2 tablets of EFV 200 mg per day given orally

Timeline

• Start date: 2020-11-01
• Primary completion: 2022-10-30
• Completion: 2023-01-31
• First posted: 2020-08-14
• Last updated: 2020-08-14