HIV/AIDS and dyslipidemia.
Conditions
Interventions
Intervention group:The intervention group received the Sanqu Xiangsha formula.
Control group:Participants in the control group were treated with oral rosuvastatin calcium.
Sponsors
The Nanning Fourth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1)Age between 18 and 65 years, inclusive; no restriction on sex. (2)Body mass index (BMI) between 18 and 30 kg/m². (3)Positive results for HIV-1 antibodies by enzyme-linked immunosorbent assay (ELISA) and confirmed by an HIV diagnostic test. (4)Documented dyslipidaemia after receiving antiretroviral therapy (ART) for =6 months, with laboratory assessments within the past 6 months showing low-density lipoprotein cholesterol (LDL-C) =3.4 mmol/L (130 mg/dL), and at least one of the following criteria (according to the 2024 Chinese Expert Consensus on Primary Prevention and Management of Hypertension, Type 2 Diabetes, and Dyslipidaemia in Adults): a. Total cholesterol (TC) >5.2 mmol/L (200 mg/dL); b. Triglycerides (TG) =1.7 mmol/L (150 mg/dL); c. High-density lipoprotein cholesterol (HDL-C) <1.04 mmol/L (<40 mg/dL for men) or <1.30 mmol/L (<50 mg/dL for women). (5)No use of lipid-lowering medications or any herbal preparations containing ingredients investigated in this study within the past 3 months. (6)CD4+ T-cell count =200 cells/µL and plasma HIV RNA <1000 copies/mL within the past 6 months. (7)Individuals living with HIV/AIDS who have been fully informed of the study procedures and have provided written informed consent.
Exclusion criteria
Exclusion criteria: (1)Patients with severe psychiatric disorders. (2)Current illicit drug use or alcohol abuse. (3)Pregnant or breastfeeding women. (4)Presence of any of the following conditions: hepatic impairment (alanine aminotransferase [ALT] and aspartate aminotransferase [AST], or total bilirubin [TB] =2× upper limit of normal [ULN]) or active liver disease or hepatic dysfunction; renal insufficiency (estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m²); coagulopathy; severe anaemia (haemoglobin <80 g/dL); hypothyroidism; severe hypertension (blood pressure =180/110 mmHg); Cushing's syndrome; type 1 or type 2 diabetes mellitus; coronary heart disease; cerebral infarction; atherosclerotic cardiovascular disease; malignant tumours; polycystic ovary syndrome (PCOS); primary or familial hyperlipidaemia; malabsorption syndromes (e.g., coeliac disease); systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA); chronic viral infections with active replication (e.g., hepatitis B virus, hepatitis C virus); hereditary disorders (e.g., sickle cell disease, phenylketonuria); or opportunistic infections within the past 6 months (e.g., tuberculosis, Talaromyces marneffei infection). (5)Conditions that may affect drug absorption (e.g., restrictive dieting, history of gastrectomy). (6)Use of lipid-lowering agents or other medications (e.g., glucocorticoids, antipsychotics, immunosuppressants) within the past 3 months. (7)At baseline assessment: ALT and/or AST =1× ULN (confirmed by a second test within 7 days) and creatine kinase (CK) =2× ULN.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-C reduction at 12 and 24 weeks;Dyslipidemia recovery rate at 12 and 24 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with LDL-C <70 mg/dL;Percentage of patients achieving =50% reduction in LDL-C;Percentage change in TC, TG, HDL, and LDL from baseline to 24 weeks;Subject-reported adverse events;Laboratory test abnormalities;Clinical examination abnormalities;Immunological recovery rate;Viral suppression rate;Medication satisfaction;Medication adherence;Relative percentage change in ApoA1 and ApoB; | — |
Countries
China
Contacts
Public ContactLemin Wen
The Nanning Fourth People's Hospital
Outcome results
None listed