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.
Aged between 18 and 65 years;
Body weight ≥ 40 kg with BMI ranging from 18.5 to 30 kg/m²;
Treatment-naïve patients with HIV-1 infection who are planned to initiate antiretroviral therapy;
Diagnosed with active Mycobacterium tuberculosis infection and receiving anti-tuberculosis regimen containing rifampicin and isoniazid;
Subjects with allergic constitution or a history of allergy to the study drugs and excipients;
Those with a history of drug addiction, substance abuse, or chronic alcoholism;
Pregnant or lactating women; women of childbearing potential who cannot adopt effective contraceptive measures (e.g., contraceptive diaphragm, condom, intrauterine device, partner vasectomy), or whose sexual partners fail to implement effective contraception;
Subjects who have used drugs with moderate to high drug drug interaction potential with the study drugs (excluding anti tuberculosis drugs) within 2 weeks prior to formal enrollment and ART initiation (only applicable to the pre trial phase);
Parallel
Ainuovirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablets
DrugAntiretroviral 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.
Tenofovir, Lamivudine and Efavirenz Disoproxil Fumarate Tablets
DrugAntiretroviral 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
Immunological efficacy (CD4+ T cell count) of the two groups at week 48
ART treatment failure rate of the two groups
Evaluate the anti-tuberculosis treatment outcomes of two groups, with primary indicators of cure rate and treatment failure rate
Incidence rates of all-grade adverse events and grade ≥3 adverse events in the two groups
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