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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Antiretroviral therapy is initiated 14 days after participants receive anti-tuberculosis treatment with rifampicin and isoniazid. The regimen is Ainuovirine 150mg, Lamivudine 300mg and Tenofovir 300mg, one tablet each time, once daily.
Antiretroviral therapy is initiated 14 days after participants receive anti-tuberculosis treatment consisting of rifampicin and isoniazid. The regimen is Efavirenz 400 mg, Lamivudine 300 mg and Tenofovir Disoproxil Fumarate 300 mg, one tablet of each taken once daily.
Viral suppression rates of two antiretroviral therapy(ART) regimens at week 48
Percentage of HIV RNA virological suppression (HIV RNA viral load \<50 copies/mL) in two groups treated with Ainuovirine-based regimen or TLE regimen for 48 weeks
Time frame: at week 48
Immunological efficacy (CD4+ T cell count) of the two groups at week 48
Time frame: at week 48
ART treatment failure rate of the two groups
Time frame: at week 48
Evaluate the anti-tuberculosis treatment outcomes of two groups, with primary indicators of cure rate and treatment failure rate
Time frame: at week 48
Incidence rates of all-grade adverse events and grade ≥3 adverse events in the two groups
Time frame: through study completion, about 48 weeks
Types and constituent ratios of adverse events above grade 1 in the two groups
Time frame: through study completion, about 48 weeks
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