acquired immunodeficiency syndrome
Conditions
Interventions
Group 1:FNC2mg+TDF+EFV+placebo
Group 2:oral FNC3mg+TDF+EFV+placebo
Group 3:oral FNC4mg+TDF+EFV+placebo
Group 4:oral 3TC+TDF+EFV+placebo
Sponsors
Beijing YouAn Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years old; 2. Confirmed HIV positive with a report; 3. Have not received anti-hiv antiviral treatment; 4. HIV viral load >=1000 copies/mL; 5. Who have no recent family planning and agree to take effective non-drug contraceptive measures during the trial period and within 3 months after the end of administration; 6. The subjects could fully understand the purpose, nature, method and possible adverse reactions of the test, and voluntarily participate in and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have received anti-HIV treatment; 2. Suffering from a serious opportunistic infection or opportunistic tumor; 3. Abnormal blood routine examination (white blood cells <3x10^9/L, hemoglobin <90g/L, neutrophils <1.5 × 109 / L, platelets <75x10^9/L); 4. Have a definite liver disease (hepatitis B surface antigen/HCV antibody positive), or abnormal liver function test (alanine aminotransferase and/or aspartate aminotransferase exceeds the upper limit of normal value by 3 times, or total bilirubin exceeds the upper limit of normal value 2 times); 5. Renal insufficiency (glomerular filtration rate <70ml/min, or creatinine above the upper limit of normal); 6. Now suffering from more serious chronic diseases, metabolic diseases (such as diabetes), neurological and psychiatric diseases; 7. Has suffered from pancreatitis; 8. Women during pregnancy and lactation; 9. allergic constitution or known to be allergic to the pharmaceutical ingredients and the basic drugs prescribed in this program; 10. Suspect or determine the history of alcohol and drug abuse; 11. Participated in other drug clinical trials (excluding Chinese medicine) within the first three months of screening; 12. With other factors that are not suitable to be involved in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with HIV viral load < 50copies/ml after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in HIV load logarithm before and after treatment, including the number of subjects whose HIV load level decreased by >=1 log from baseline before and after treatment; CD4 cell count before and after treatment; | — |
Countries
China
Contacts
Public ContactWu hao
Beijing You'An Hospital
Outcome results
None listed