About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Ainuovirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablets
- Tenofovir, Lamivudine and Efavirenz Disoproxil Fumarate Tablets