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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TLE group | Active Comparator | 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. |
|
| ALT group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ainuovirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablets | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunological efficacy (CD4+ T cell count) of the two groups at week 48 | at week 48 | |
| ART treatment failure rate of the two groups | at week 48 | |
| Evaluate the anti-tuberculosis treatment outcomes of two groups, with primary indicators of cure rate and treatment failure rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Chen | Contact | 021-37990333 | chenjun@shaphc.org | |
| Ling Gu | Contact | 021-37990333 | guling@shaphc.org |
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|
| Tenofovir, Lamivudine and Efavirenz Disoproxil Fumarate Tablets | Drug | 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. |
|
| at week 48 |
| Incidence rates of all-grade adverse events and grade ≥3 adverse events in the two groups | through study completion, about 48 weeks |
| Types and constituent ratios of adverse events above grade 1 in the two groups | through study completion, about 48 weeks |
| ID | Term |
|---|---|
| D055985 | Latent Tuberculosis |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000085343 | Latent Infection |
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| ID | Term |
|---|---|
| D019259 | Lamivudine |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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