AIDS
Conditions
Interventions
Experimental group:Lamivudine / dotiravir
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. People living with HIV-1; 2. Aged 18 to 70 years; 3. Informed of the study protocol, agreed to participate in the study and voluntarily signed the informed consent; 4. Subjects need to complete the study as planned; 5. Subjects must have no history of drug abuse, acute major organ disease or potential long-term overseas work; 6. Subjects must have a confirmed diagnosis of HIV-1 infection and be willing to initiate antiretroviral therapy immediately; 7. HIV infected persons who have not received antiviral treatment in the past: if the subjects have taken pre exposure and post exposure prophylactic drugs, the last time they took pre exposure and post exposure prophylactic drugs is more than 2 months from the time of diagnosis; 8. The female subjects were not pregnant.
Exclusion criteria
Exclusion criteria: 1. Subjects who are breastfeeding, planning to be pregnant or breastfeeding during the study period; 2. Subjects in the first three months of pregnancy; 3. The results of HIV-1 drug resistance genotypes were known to be resistant to therapeutic drugs before screening; 4. Except for esophageal candidiasis and cutaneous Kaposi's sarcoma which do not need systematic treatment, any active stage 3 disease defined by CDC stage in the United States; 5. Subjects with known or suspected hepatitis B infection; 6. Known or suspected severe liver damage or unstable liver disease (defined as presence of ascites, encephalopathy, coagulation dysfunction, hypoalbuminemia, esophageal or gastric varices, persistent jaundice), cirrhosis, known biliary abnormalities (except Gilbert syndrome or asymptomatic gallstones); 7. Subjects with known moderate to severe renal impairment (creatinine clearance less than 30 ml / min / 1.73 m2); 8. Patients with persistent malignancies other than basal cell carcinoma, or resected non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia; 9. The researchers think that the subjects have obvious suicide risk; 10. The researcher believes that any pre-existing physical or mental condition of the subject may prevent the subject from complying with the administration plan, or may endanger the safety of the subject; 11. Subjects with drug abuse disorders or social constraints that researchers believe may hinder the successful initiation of antiretroviral therapy; 12. Subjects with a history of allergy to the study drug or its components or with allergy or intolerance; 13. Those who received any of the following drugs within 28 days: astemizole, cisapride, ergot derivatives, hydroxyurea, midazolam, thalidomide, triazolam, vincristine, zacitabine, ribavirin, adriamycin, voriconazole, St. John '; 14. Receiving any prohibited drug treatment and unwilling or unable to switch to other drugs; 15. Contact with other test drugs or test vaccines within 28 days before the treatment drugs in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| human immunodeficiency virus load; | — |
Secondary
| Measure | Time frame |
|---|---|
| CD4+T lymphocyte; | — |
Countries
China
Contacts
Public ContactDing Haibo
The First Affiliated Hospital of China Medical University
Outcome results
None listed