HIV-1
Conditions
Interventions
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 one HIV RNA <50 copies/ml in the last six months (3) Elevated or borderline elevated lipids in at least one of the four lipid profiles or Weight Gain =5% Following Initiation of Antiretroviral Therapy (4) 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) any patient with severe diabetes mellitus, cardiovascular disease, or other chronic disease that has been evaluated by a physician to be unstable (4) Suffering from major mental illnesses such as schizophrenia, epilepsy, severe depression/anxiety, etc; (5). During the acute infection period of HIV-1 or currently suffering from AIDS related diseases; (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 or aspartate aminotransferase>5 * ULN; (11). Creatinine>=ULN and the estimated creatinine clearance rate according to the CCr formula [1] is less than 60 ml/min. Male=1.23; Female=1.03; (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 |
|---|---|
| HIV RNA <50 copies/ml ;lipid profile; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Countries
China
Contacts
Public ContactQingxia Zhao
The Sixth People's Hospital of Zhengzhou
Outcome results
None listed