AIDS
Conditions
Interventions
Observational cohort (Exposure: switch from an INSTI-based regimen to ANV/3TC/TDF therapy):None
Control cohort (Exposure: continuation of the original INSTI-based regimen):None
Sponsors
The Second Hospital of Nanjing
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: a. Age >= 18 years and 1000 copies/mL); ? an epidemiological history or AIDS-related clinical manifestations, with two positive HIV nucleic acid tests; ? a positive HIV isolation test). c. Previous treatment with an INSTI-containing antiretroviral therapy regimen for at least 6 months, with at least two consecutive HIV-1 RNA test results = 12 weeks) prior to screening. d. HIV RNA = 26 kg/m^2 at screening; or weight gain exceeding 10% after starting (or switching to) an integrase inhibitor-based antiviral regimen, and BMI >= 24 kg/m^2. f. No known plans or potential changes or initiations of medications known to be associated with significant weight loss during the study. g. Female participants agree to use contraceptive measures while taking the study medication and for 8 weeks after the study. h. Able to understand and comply with the study protocol and voluntarily sign a written informed consent.
Exclusion criteria
Exclusion criteria: a. Patients with previous drug resistance results demonstrating a major resistance mutation to non-nucleoside reverse transcriptase inhibitors, lamivudine, or tenofovir. b. Patients with previous treatment failure requiring a change in treatment regimen due to non-nucleoside therapy. c. Patients with diabetes, cardiovascular disease, or other chronic medical conditions whose condition is unstable as assessed by a physician. d. Patients planning fat-reduction surgery or major dietary or exercise modifications during the study period. e. Any of the following medications are expected to be started or discontinued during the study period: 1) Antipsychotics associated with weight gain (e.g., clozapine, olanzapine, risperidone, etc.) and antidepressants (tricyclic antidepressants such as amitriptyline, nortriptyline, etc.; selective serotonin reuptake inhibitors such as fluoxetine, paroxetine, sertraline, etc.; and monoamine oxidase inhibitors such as selegiline); 2) Anticonvulsants/mood stabilizers associated with weight gain (e.g., lithium, valproate) or anticonvulsants for weight loss (e.g., topiramate); 3) Thyroid replacement hormone; 4) Antidiabetic drugs B that are known to cause weight loss (for example, GLP-1 receptor agonists such as exenatide, dulaglutide, semaglutide, metformin and SGLT-2 inhibitors such as canagliflozin and dapagliflozin). f. Currently suffering from AIDS-related illnesses. g. A history of drug abuse, alcohol, or drug dependence. h. Any condition that the investigator deems may endanger the subject's safety or affect compliance with the trial protocol. i. Use of systemic immunosuppressive therapy or immunomodulatory agents within 30 days prior to treatment in this study, or unavoidable use during the clinical trial. j. Glutamate aminotransferase or aspartate aminotransferase > 5 ULN. k. Creatinine >= 1.5 ULN or creatinine clearance (CrCl) estimated by the CKD-EPI equation < 50 ml/min. l. History of osteoporosis or osteopenia. m. History of allergy or hypersensitivity to any component or excipient of the study drug. n. Subjects must have active pulmonary tuberculosis and be undergoing treatment at the time of screening. o. Pregnant or breastfeeding women, or planning to become pregnant during the study. p. Participated in other drug trials within the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change (Percent) in Body Weight (kg) From Entry to Week 48; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change (Percent) in Body Weight (kg) From Entry to Week 12,24 and 36;Change in waist circumference (cm), expressed as percentage change from baseline to Weeks 12, 24, 36, and 48.;Change in fasting cardiovascular and metabolic parameters (glucose, HbA1c, insulin, HOMA-IR, triglycerides, LDL-C, HDL-C) from baseline to Weeks 12, 24, 36, and 48.;Proportion of patients with HIV-1 RNA 10% decline in estimated creatinine clearance (CrCl, calculated by the CKD-EPI equation) from baseline to Weeks 12, 24, 36, and 48.;Percentage change in total fat mass from baseline to Week 48.;Percentage change in lean body mass from baseline to Week 48.;Percentage change in trunk fat mass from baseline to Week 48;Percentage change in limb fat mass from baseline to Week 48;Percentage change in appendicular lean mass from baseline to Week 48.;Percentage change in bone mineral density (BMD) of the hip and lumbar spine from baseline to Week 48.;Change in CAP (Controlled Attenuation Parameter) and LSM (Liver Stiffness Measurement) values assessed by transient elastography from baseline to Week 48.; | — |
Countries
China
Contacts
Public ContactZhiliang Hu
The Second Hospital of Nanjing
Outcome results
None listed