HIV-1
Conditions
Interventions
Experimental group 1 (ANV/3TC/TDF+ Rifampicin + Isoniazid based Anti-tuberculosis Treatment):None
Experimental group 2 (ANV/3TC/TDF+ Rifabutin + Isoniazid based anti-tuberculosis treatment):None
HIV-1 uncomplicated TB group (ANV/3TC/TDF):None
Sponsors
Guiyang Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for the control group: (HIV-1 uncomplicated Mycobacterium tuberculosis infection) ? Age = 18 years, both sexes; ? Diagnosed with HIV-1 infection, never received ARV treatment and subject is judged to be suitable for ANV/3TC/TDF regimen by the investigator; ? Be able to fully understand the nature, method, and possible reactions of this experiment, and comply with the requirements of the study and voluntarily sign a written informed consent form. Trial group inclusion criteria: (HIV-1 combined with Mycobacterium tuberculosis infection) ? All requirements of the control group enrolment criteria need to be met; ? Diagnosed with Mycobacterium tuberculosis infection (including clinical diagnosis) before initiating antiviral drugs and never received anti-tuberculosis treatment, and subject is judged to be suitable for anti-tuberculosis regimens containing at least rifampicin + isoniazid or rifabutin + isoniazid; ? Individuals who have only received an anti tuberculosis regimen (containing at least rifampicin+isoniazid or rifaputin+isoniazid) within 7 days prior to initiating antiviral therapy with ANV, and have only received an anti tuberculosis regimen+anti HIV regimen within 7 days prior to sample collection in the second PK trial.
Exclusion criteria
Exclusion criteria: ? Allergy or history of allergy to the drugs and excipients in this test; ? Drugs metabolised via the CYP2C19 pathway (e.g. citalopram, escitalopram, etc.) or with significant effect on CYP2C19 ( induction or inhibition, e.g. aspirin, carbamazepine, prednisone, kynurenine, fluconazole, voriconazole, omeprazole, fluoxetine, fluvoxamine, paroxetine, cimetidine, lansoprazole, phenytoin, etc.) used in the 2 weeks prior to the start of the study; ? Consumption of foods with potential effects on the CYP2C19 metabolic pathway (e.g. mango, dragon fruit, grapefruit, grapefruit, etc.) within 1 week prior to study entry or within 7 days prior to initiation of the ANV-containing antiviral regimen and within 7 days prior to the second PK trial; ? Those who are unable to abstain from alcohol or who are unable to stop using any tobacco-based products within 7 days prior to initiation of the ANV-containing antiviral regimen and within 7 days prior to the second PK trial; ? Baseline resistance testing results showing resistance to non-nucleosides, 3TC, TDF; ? Drug-resistant TB confirmed by drug susceptibility testing. ? Patients with central nervous system tuberculosis who need to adjust the dosage or frequency of routine anti tuberculosis drugs; ? Individuals who have participated in other intervention clinical trials or donated or lost = 400ml of blood or Hb ULN; ? Creatinine = ULN or glomerular filtration rate (GFR) = 90 (ml/minute/1.73 m2) as derived from the CKD-EPI creatinine equation; ? Other conditions deemed by the investigator to be unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters; | — |
Countries
China
Contacts
Public ContactZeng Wenji
Guiyang Public Health Clinical Center
Outcome results
None listed