drugset / Trial / NCT07631897
Comparative Trial Between Ainuovirine(ANV)/Lamivudine(3TC)/Tenofovir(TDF) and Efavirenz(EFV)/Lamivudine/Tenofovir Regimens
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective, multicenter, open-label, parallel-controlled study. The primary objective is to prospectively explore and compare the virological efficacy of Ainuovirine/Lamivudine/Tenofovir and Efavirenz/Lamivudine/Tenofovir regimens combined with rifampicin and isoniazid-based anti-tuberculosis therapy in HIV-infected patients with active tuberculosis. Participants are divided into two groups to compare the virological suppression rate and immunological efficacy between the two antiretroviral regimens. All subjects will receive continuous antiretroviral medication and anti-tuberculosis drugs under medical supervision throughout the study.
Timeline
- Start
- 2026-06
- Primary completion
- 2028-06
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Efavirenz | Other / unclassified | 400 mg | — |
| Subject | KM-023 | Unknown | 150 mg | — |
| Background | Lamivudine | Other / unclassified | 300 mg | — |
| Background | Tenofovir disoproxil fumarate | Small molecule | 300 mg | — |