ADIS, TB
Conditions
Interventions
Main trial -Control group:EFV 400mg, 3TC 300mg, TDF 300mg, 1 tablet each time, once a day (take on an empty stomach before going to bed every day)
Anti-tuberculosis drugs should be taken once daily (including at least 450mg to 600mg of rifampicin and 300mg of isoniazid) (taken on an empty stomach at 8:00 every day).
Main trial - Intervention group:Enomitinib tablets, a compound preparation, each tablet contains 150mg of ANV, 300mg of 3TC, and 300mg of TDF. Take 1 tablet each time, once a day (18:00 with meals dai
Pre-experimental group:Enomitinib tablets, a compound preparation, each tablet contains 150mg of ANV, 300mg of 3TC, and 300mg of TDF. Take 1 tablet each time, once a day (18:00 with meals daily).
Anti
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 65 years; 2.Body weight >= 40 kg with BMI ranging from 18.5 to 30 kg/m^2; 3.Treatment-naïve patients with HIV-1 infection who are planned to initiate antiretroviral therapy; 4.Diagnosed with active Mycobacterium tuberculosis infection and receiving anti-tuberculosis regimen containing rifampicin and isoniazid; 5.CD4? T cell count >= 25 cells/µL; 6.HIV RNA viral load < 500,000 copies/mL; 7.Subjects who can fully understand the nature, methods and potential adverse reactions of this trial, comply with the requirements stated in the informed consent form, and voluntarily sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Subjects with allergic constitution or a history of allergy to the study drugs and excipients; 2.Those with a history of drug addiction, substance abuse, or chronic alcoholism; 3.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; 4.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); 5.Those who are unable to receive oral anti-tuberculosis treatment during antiretroviral therapy; 6.Subjects with baseline drug resistance test results showing resistance to NNRTIs, 3TC or TDF; 7.Those with resistance to one or more anti-tuberculosis drugs; 8.Subjects diagnosed or tentatively diagnosed with tuberculous meningitis; 9.Patients complicated with other severe opportunistic infections besides Mycobacterium tuberculosis infection; 10.Abnormal liver function: alanine transaminase (ALT)/aspartate transaminase (AST) > 3×ULN with clinical symptoms, or > 5×ULN without symptoms; total bilirubin (TBil) > 2×ULN; 11.Impaired renal function: estimated glomerular filtration rate (eGFR) calculated by the CKD-EPI formula < 60 mL/min/1.73 m^2; 12.Subjects complicated with tumors, severe neurological or psychiatric diseases, metabolic disorders, gastrointestinal diseases or other comorbidities that, in the investigator’s judgment, may affect their participation and completion of the study; 13.Any other conditions deemed inappropriate for enrollment by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Viral suppression rates of two ART regimens at week 48;Time to virological failure of two ART regimens;Time to achieve virological suppression of two ART regimens; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunological efficacy (CD4+ T cell count) of two groups at week 12 and week 48;Treatment outcomes of tuberculosis in two groups;Treatment failure rate of ART in two groups;Incidence of all-grade adverse events and grade =3 adverse events in two groups;Types and constituent ratios of grade 1 and above adverse events in two groups; | — |
Countries
China
Contacts
Public ContactChen Jun
Shanghai Public Health Clinical Center
Outcome results
None listed