AIDS
Conditions
Interventions
5 mg Sifuvirtide group:Subcutaneous injection of 5 mg Sifuvirtde once daily for continuous14 days
1 mg Sifuvirtide group:Subcutaneous injection of 1 mg Sifuvirtde once daily for continuous 14 days
30 mg Sifuvirtide group:Subcutaneous injection of 30 mg Sifuvirtde once daily for continuous 14 days
10 mg Sifuvirtide group:Subcutaneous injection of 20 mg Sifuvirtde once daily for continuous 14 days
20 mg Sifuvirtide group:Subcutaneous injection of 20 mg Sifuvirtde once daily for continuous 14 days
Sponsors
Beijing You An Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Subject who was positive in HIV antibody test (western blot, W.B); (2) Aged 18-45 years inclusive (male-female), and the difference in age of volunteers in the same batch should be no more than 10 years; (3) CD4 cell (absolute counting) = 200 cell/mm3 (flow cytometry, BD), Virus load = 5000 copies/ml (bDNA detection); (4) Subject with Body weight > 40 kg, and Body Mass Index (BMI = body weight / body height2): 20.0-27.0Kg/m2; (5) Subject was in a good healthy condition as established by medical history, physical examination, and electrocardiogram, results of biochemistry, hematology and urinalysis testing, HbsAg, HbsAb, HbeAg, HbeAb, HbcAb, HCV-Ab, chest X ray examination, B type ultrasonic examination; (6) No history of gastrointestinal, hematological system,metabolism abnormality, mental disorder, hereditary disease; (7) Subject who was not addicted to smoking and drinking; and agreed to give up smoking and drinking during study; (8) Subject who stopped receiving anti-HIV drug over half year or subject who never received any anti-HIV drug; (9) Subjects should understand the purpose, characteristics, procedures of the investigational drug study, as well as the adverse event which might occur
Exclusion criteria
Exclusion criteria: (1) Patient in acute infection phase; (2) Patient who received any other anti-HIV drug within half year prior to screening; (3) CD4 < 200 cell/ml (flow cytometry, BD), virus load < 5000 copies / ml; (4) The value of ALT was 2-fold more than the normal value, or the value of Cr was more than that of healthy adult; abnormalities were observed in physical examination, biochemistry, hematology and urinalysis testing; (5) Subject with serious mental disorder and nervous disease; (6) Subject with serious opportunistic infection and opportunistic tumor; (7) History of medication abuse; (8) Subject with allergic constitution; (9) Pregnant woman and breast feeding women; (10) Subjects who had a history of alcohol abuse or often smoking and cannot stop smoking and drinking; (11) Febrile illness within 3 days before dosing; (12) Subjects who received any experimental drug within the 3 months prior to the first dose of study medication; (13) In the opinion of the investigator, a subject who was not suitable to participate the study for whatever reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety indexe; | — |
Secondary
| Measure | Time frame |
|---|---|
| CD4 count;HIV viral loa; | — |
Countries
China
Contacts
Public ContactWu Hao
Outcome results
None listed