AIDS
Conditions
Interventions
20 mg Sifuvirtide group:Subcutaneous injection of 20 mg Sifuvirtde once daily for 28 consecutive days
10 mg Sifuvirtide group:Subcutaneous injection of 10 mg Sifuvirtde once daily for 28 consecutive days
Sponsors
Beijing Youan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Subjects who were positive in HIV antibody test (western blot, W.B); (2) 18-45 years old, male and female, difference in subject age should not be too much in same batch; (3) CD4 cell (absolute counting) >=250 cell/mm3, Virus load >=5000 copies/mL (bDNA detection); (4) Subjects with body weight > 40 kg, and Body Mass Index (BMI = body weight / body height2): 18.0-27.0 kg/m2; (5) Subjects were in a good healthy condition as established by results of physical examination, biochemistry, hematology and urinalysis test, chest X ray examination, B type ultrasonic examination and electrocardiogram etc., without serious liver and renal damages; (6) No medical history of gastrointestinal, hematological system,metabolism abnormality, mental disorder, hereditary disease; (7) Subjects who were not addicted to smoking and drinking and agreed to give up smoking and drinking during study; (8) Subjects 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 during study. Subject should participate in the study of his own accord and sign Informed Consent Form prior to screening evaluations.
Exclusion criteria
Exclusion criteria: (1) Patients in acute infection phase; (2) Patients who received any other anti-HIV drug within half year prior to screening; (3) CD4 < 250 cell/mL, virus load < 5000 copies / mL; (4) The value of ALT was 2-fold more than its normal value, or the value of Cr was more than that of healthy adult; abnormalities were observed in physical examination, biochemistry, hematology and urinalysis test; (5) Subjects with serious mental disorder and nervous disease; (6) Subjects with serious opportunistic infection and opportunistic tumor; (7) History of medication abuse; (8) Subjects with allergic constitution, or allergic history of two or more drug or food; (9) Pregnant women, breast feeding women, and women in child-bearing age disagreed with adopting contraceptive measures; (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 investigational 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 this study for whatever reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety indexes;Pharmacokinetics indexes; | — |
Secondary
| Measure | Time frame |
|---|---|
| HIV viral load;CD4 count; | — |
Countries
China
Contacts
Public ContactLi Ning
Outcome results
None listed