AIDS
Conditions
Interventions
Group 1 :Subcutaneous injection of 20 mg Sifuvirtde for Injection once daily for 14 days
Group 2:Subcutaneous injection of 20 mg Sifuvirtde for Injection twice daily (interval of 12h+/-1h) for 14 days
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Patients must be 18-45 years old, male or female, with body weight of more than 40 kg; 2. Patients must be positive in HIV antibody test (western blot, W.B) or have medical certificate of HIV infection; 3. Patients with CD4 cell >=350 cell/L(BD Flow cytometry), and viral load >=5,000 copies/mL, and are unwilling to receive ART therapy; 4. Patients who are not addicted to smoking and drinking and agreed to give up smoking and drinking during study; 5. Patients never receive anti-HIV treatment, or have stopped taking anti-AIDs medication for more than half a year; 6. Patients must understand the purpose, characteristics, procedures of the study, as well as the adverse event which might occur during study. Patients should voluntarily participate in the study and sign Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Patients in acute infection phase; 2. Patients who received other anti-HIV drug within a half year or paticipate in any other study of investigational drug within 3 months prior to screening; 3. Patients with serious opportunistic infection or opportunistic tumor; 4. The value of ALT was more than 2-fold the upper limit of normal value, significant abnormalities were observed in physical examination, biochemistry, hematology or urinalysis test; 5. Patients with serious gastrointestinal disease, hematological system disease, metabolic disorder, neurological disorder and mental illness,et.al.; 6. Subjects with allergic constitution, or with allergic experience to two or more drug or food; 7. Febrile illness within 3 days; 8. Pregnant women (the urine pregnancy test was positive), breast feeding women, or women in child-bearing age unable to take contraceptive measures; 9. Patients who had a history of alcohol abuse or drug abuse; 10. Patients who are not suitable to participate in this study judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| viral load;Safety indexes; | — |
Secondary
| Measure | Time frame |
|---|---|
| CD4 count; | — |
Countries
China
Contacts
Public ContactWu hao
Outcome results
None listed