HIV infection
Conditions
Interventions
The Group of BIC:Medication and examination according to the treatment plan, without any additional preventive measures
The Group of EFV:Medication and examination according to the treatment plan, without any additional preventive measures
Sponsors
The Third People's Hospital of Shenzhen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria :(1) Age = 18 years (2) Diagnosed with HIV-1 infection, never received ARV treatment and subject is judged to be suitable for ART regimen by the investigator. (3) Normal lipid profile (accounting for 50% of patients in each group), or one of the lipidprofiles,(TC, TG, and LDL-C,)is borderline elevated (accounting for 50% of patients in each group) (4) normal (BMI 18.5-23.9, accounting for 50% of patients in each group), or overweight (BMI 24-27.9, accounting for 50% of patients in each group) (5) Understand and comply with the requirements of the study protocol and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion criteria (1) Receiving lipid-lowering medication treatment (2) Using medication or treatment related to weight control (3) Status of acute HIV-1 infection or currently suffering from AIDS-related complex. (4) History of drug abuse, or has a recent history of alcohol/drug dependence. (5) Any condition considered by the investigator that may compromise the safety of the subject and affect compliance with the study protocol. (6) Participated in a clinical trial with an investigational compound/therapeutic device within 30 days prior to enrollment of this study. (7) Used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or could not avoid using them during the course of the study. (8) Alanine aminotransferase or aspartate transferase>5 * ULN (9) Creatinine >1.5×ULN or a glomerular filtration rate (GFR) =60 (mL/minute/1.73 m2) as derived from the CKD-EPIcreatinine formula (GFR = a*(serum creatinine)/b)^c*(0.993)^age. The a values differ according to gender and ethnicity: blacks: females = 166, males = 163; whites and other ethnicities: females = 144, males = 141. The b values differ according to sex: females = 0.7; males = 0.9. The c values differ according to sex and serum creatinine values: females: c = -0.329 for serum creatinine =0.7 mg/dL, c = -1.209 for serum creatinine >0.7 mg/dL; males: c = -0.411 for serum creatinine =0.7 mg/dL, c = -1.209 for serum creatinine >0.7 mg/dL.. (10) Hb = 90g/L (11) Glucose test#Fasting blood sugar>6.1mmol/L (12) A history of allergy or hypersensitivity to any component or excipient of the investigational drug. (13) Suffering from major mental illnesses such as schizophrenia, epilepsy, severe depression/anxiety (14) Complicated with severe Opportunistic infection, who is not suitable to participate in this study according to the judgment of the investigator (15) Women who are pregnant or breastfeeding; women of childbearing age who are not using contraception (e.g., contraceptive diaphragm; condom; IUD, etc.; partner vasectomy); female subjects who are unwilling to continue using an investigator-approved form of contraception from screening until 6 months after the last dose of trial drug. Male subjects with active heterosexual sex without vasectomy who are not using birth control methods or who do not wish to continue using contraception during the trial and at least within 30 days after the end of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total cholesterol, TC;triglyceride, TG;LDL-C;HDL-C; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood routine examination;blood-biochemical;HIV RNA;CD4+;CD4+/CD8+; | — |
Countries
China
Contacts
Public ContactHui Wang
The Third People's Hospital of Shenzhen
Outcome results
None listed