HIV/AIDS co-infected with tuberculosis
Conditions
Interventions
Control group:After 2 weeks of anti-tuberculosis treatment, antiviral treatment began. The triple antiviral treatment regimen consisted of tenofovir (300mg per dose, once daily), lamivudine (300mg per
Experimental group:After 2 weeks of anti-tuberculosis treatment, antiviral therapy was initiated with a dual antiviral treatment regimen consisting of dotiravir (50mg per dose, once daily) and lamivud
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients need to meet all the conditions listed below: (1) Age = 18 years old; (2) Confirmed HIV-1 infection; (3) Co-infected with tuberculosis (including confirmed and clinically diagnosed cases), they have not received anti tuberculosis treatment in the past or have not received anti tuberculosis treatment for more than 14 days; (4) HIV-1 virus load below 500000 copies/milliliter; (5) Never used anti HIV drugs; (6) If the subject is female and willing to take effective contraceptive measures during the experiment; (7) Voluntarily sign the patient's informed consent form and ensure follow-up; (8) The researchers believe that the overall condition of the subjects does not affect the evaluation and completion of the experiment.
Exclusion criteria
Exclusion criteria: If a patient has one of the following conditions, they must be excluded from this experiment: (1) Known to be allergic or intolerant to certain pharmaceutical ingredients or excipients in Dotiravir, Lamivudine, Efeviren, and Tenofovir; (2) HIV is resistant to docetavir, lamivudine, efaviren, or tenofovir; (3) Concomitant hepatitis B virus infection; (4) Drug-resistant tuberculosis; (5) Serum amylase and/or lipase are greater than three times the normal upper limit, or doctors believe there is a possibility of pancreatitis; (6) Creatinine clearance rate3 times the upper limit of normal value; (8) Child Pugh C-level, i.e. Child Pugh score = 10 points; (9) Blood lactate>2mmol/l, or doctors believe there is a possibility of lactic acid poisoning; (10) Patients with combined biliary obstruction; (11) Severe depression or anxiety, or the presence of other mental and psychological disorders; (12) Combined with malignant tumors; (13) Using metformin and not switching to other hypoglycemic drugs; (14) The combined use of drugs other than rifampicin can significantly affect the blood concentration of antiviral drugs; (15) Being treated for other diseases defined by AIDS (maintenance treatment); (16) There is abuse of substances such as alcohol and drugs; (17) Pregnant women, lactating women, and women with fertility plans within the next year; (18) The doctor believes that the patient is not suitable for using any of the antiviral regimens involved in this study; (19) Other doctors believe that participating in this study will increase patient risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with HIV-1 virus load below 50 copies/mL at 24 weeks of antiviral therapy in the intentionality analysis set; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with HIV-1 virus load below 50 copies/mL at 12 weeks of antiviral therapy in the intentionality analysis set;Proportion of subjects with HIV-1 virus load below 50 copies/mL at 12 weeks of antiviral therapy in the intentionality analysis set;Proportion of subjectad lower than 50 copies/mL at 12, 24, and 48 weeks of antiviral therapy in the protocol sets with HIV-1 virus lo;CD4 count from screening visits to 24 weeks of antiviral treatment;Valley concentration of docetavir at 4, 8, 12, 24, and 48 weeks;Drug related adverse events at level 3 and above;The proportion of subjects with negative acid fast staining smears and Mycobacterium culture at 6 and 10 weeks of antiviral treatment in the intentionality analysis set;Serious adverse events;Adverse events that require discontinuation of medication;Acquired drug resistance in subjects who failed antiviral therapy; | — |
Countries
China
Contacts
Public ContactYinzhong Shen
Shanghai Public Health Clinical Center
Outcome results
None listed