Acquired Immune Deficiency Syndrome
Conditions
Interventions
GLP-1 receptor agonist weight-loss regimen:Weeks 1–4: 0.25 mg once weekly
Weeks 5–8: 0.5 mg once weekly
Weeks 9–12: 1 mg once weekly
Weeks 13–16: 1.7 mg once weekly
Weeks 17–24: maintain 1.7 m
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Confirmed HIV infection and receiving antiviral therapy for more than 6 months; 2. Age 18-60 years; 3. HIV viral load =200 cells/mm^3; 5. Body mass index >=30kg/m^2 (obesity), or >=27kg/m² to <30kg/m^2 (overweight) with at least one weight-related comorbidity (such as hyperglycemia, hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, etc.); 6. Voluntarily receiving injection of GLP-1 receptor agonist therapy; 7. Voluntarily sign the patient's informed consent form and can guarantee follow-up; 8. There is no plan to move out of the current test site during the trial.
Exclusion criteria
Exclusion criteria: 1. Obesity caused by other endocrine diseases: including hypothyroidism, Cushing's syndrome, primary and secondary hypogonadism, hypothalamic disease, insulinoma, etc.; 2. Obesity caused by the use of drugs known to be associated with weight gain (e.g., hormones, olanzapine, clozapine); 3. Subjects who have received GLP-1 receptor agonists (including liraglutide, hemimaglutide or exenatide), dipeptidyl peptidase-4 inhibitors or insulin therapy (including saxagliptin, linagliptin, sitagliptin) within the last 3 months; 4. Those who have taken other drugs for weight loss (orlistat or traditional Chinese medicine, etc.) within 3 months; 5. Opportunistic infection (as stipulated in the National AIDS Diagnosis and Treatment Guidelines) or AIDS-related malignancy within 3 months before enrollment; 6. With active autoimmune disease; 7. Personal or family history of medullary thyroid cancer; 8. Patients with multiple endocrine neoplasia syndrome type 2; 9. Diagnosed or suspected acute hepatitis and chronic active hepatitis within 30 days before enrollment; 10. Patients with chronic kidney disease (CKD) or creatinine clearance (CCr) < 60 mL/min; 11. Those who currently suffer from acute or chronic pancreatitis; 12. Current application or use of other investigational drugs or immunomodulators within 30 days before treatment; 13. Current drug addicts; 14. Patients with severe psychiatric and neurological diseases; 15. Those with intellectual disabilities or those who cannot communicate effectively with doctors; 16. Those who have a history of alcohol abuse and cannot stop drinking; 17. Non-Chinese nationals.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medical history, physical examination;BMI, waist circumference, hip circumference;Plasma HIV-1 viral load;Cluster of Differentiation 4, Cluster of Differentiation 8;Complete blood count (CBC);Urinalysis;Liver function tests (ALT, AST, GGT, ALP, TBIL/DBIL, TP, ALB);Serum creatinine, BUN, cystatin-C;Fasting plasma glucose, HbA1c, insulin;Serum lipids: TG, TC, HDL-C, LDL-C, apoA, apoB, Lp(a);ß2-microglobulin, high-sensitivity C-reactive protein (hs-CRP);Abdominal MRI, liver MRI;Body composition analysis;Cardiac MRI (pericardial fat, coronary artery calcium [CAC] score);Vascular ultrasonography;Immune activation markers;HIV reservoir assays;Cytokine profiles;Gut microbiota; | — |
Countries
CHINA
Contacts
Public ContactHaibo Ding
The First Hospital of China Medical University
Outcome results
None listed