HIV-1 infection
Conditions
Interventions
BIC/FTC/TAF group:Switch to BIC/FTC/TAF
Sponsors
The Sixth People's Hospital of Zhengzhou
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Aged >=18 years ; (2) Diagnosed HIV-1 infection, previously treated with ARVs for more than 6 months and have had at least once undetectable HIV RNA in the last 3 months; (3) Understand and comply with the requirements of the study protocol and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Presence of resistance mutations to non-nucleoside drugs, lamivudine and tenofovir (2) History of NNRTI failure (3) Using ANV or BIC containing regimen during switching; (4) Currently using drugs or treatments related to weight control; (5) Patients diagnosed with AIDS-related conditions and receiving potent CYP2C19 inhibitors (e.g. fluconazole, trichlorobenzidazole, fluoxetine) or inducers (e.g. rifampicin, Dilantin); (6) Individuals with a history of drug use or recent history of alcohol or drug dependence; (7) Any situation that the researcher believes may endanger the safety of the subjects and affect compliance with the trial protocol; (8) Those who have participated in clinical trials of other drugs or therapeutic devices within 30 days prior to enrollment in this study; (9) Have used systemic immunosuppressive therapy or immunomodulators within 30 days prior to the treatment in this study, or cannot avoid using them during clinical trials; (10) Alanine aminotransferase, aspartate aminotransferase or total bilirubin > 5×ULN; (11) Creatinine = 1.5 × ULN or glomerular filtration rate (GFR) calculated based on CKD-EPI creatinine formula = 60 ml/minute/1.73 m2; (12) Individuals with a history of allergies or hypersensitivity to any component or excipient of the investigational drug; (13) Pregnant or lactating women; Women of childbearing age who have not taken contraceptive measures that researchers consider effective, such as contraceptive diaphragms, condoms, intrauterine devices, or partner vas deferens ligation. Among males who have engaged in active heterosexual behavior and have not undergone vasectomy, male subjects who have not taken birth control measures or are unwilling to continue using contraceptive measures during the trial period until at least 30 days after the end of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with an undetectable HIV RNA at 48 weeks;Changes in blood lipids from baseline after 48 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with an undetectable HIV RNA at 24 weeks;Percentage of patients with HIV RNA<200 copies/ml at 24 and 48 weeks;Changes in CD4+T cells and CD4+/CD8+ from baseline at 24 and 48 weeks;Changes in four blood lipid levels from baseline at 24 weeks;The changes in metabolic markers (e.g. BMI, waist circumference, blood pressure, fasting glucose, fasting insulin) from baseline to weeks 24 and 48;Changes in ASCVD risk assessment from baseline at 24 and 48 weeks;Adverse events during 48 weeks;The changes in insulin resistance index from baseline to weeks 24 and 48; | — |
Countries
China
Contacts
Public ContactQingxia Zhao
The Sixth People's Hospital of Zhengzhou
Outcome results
None listed