AIDS
Conditions
Interventions
Group 1:HAART and Subcutaneous injection of Sifuvirtde for Injection once daily for 24 weeks
Group 2:HAART for 24 weeks
Sponsors
Beijing Youan Hospital
Eligibility
Sex/Gender
All
Age
16 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Patients must be 16 - 60 years old, male and female; (2) Patients must be positive in HIV antibody test (western blot, W.B); (3) Patients must have previous antiretroviral (ARV) experience in NRTIs/NNRTIs for more than 6 months; (4) Patients must have HIV viral load >=5,000 copies/mL at screening (bDNA detection); (5) Patients must have CD4 cell (absolute counting) >=50 cell/mm3; (6) Patients must be 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; (7) Patients must 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 must have previous antiretroviral (ARV) experience in NRTIs/NNRTIs for less than 6 months; (2) Patients with HIV viral load < 5,000 copies/mL at screening (bDNA detection) must be excluded; (3) Patients with CD4 cell < 50 cell/mm3 must be excluded; (4) Patients in acute infection phase must be excluded; (5) Patients with serious opportunistic infection and opportunistic tumor must be excluded; (6) Patients whose value of ALT is 3-fold more than its normal value or value of Cr is more than its normal value must be excluded; (7) Patients with serious chronic disease, metabolic disease (such as diabetes), mental disorder and nervous disease must be excluded; (8) Patients had had a pancreatitis; (9) Pregnant women, breast feeding women, and women in child-bearing age disagreed with use of birth control must be excluded; (10) In the opinion of the investigator, patients had a low entry possibility (such as poor healthy, bad compliance and so forth); (11) Subjects with allergic constitution, or allergic history of the investigational drug and HAART drugs; (12) Patients who had a history of alcohol abuse or drug abuse; (13) Patients who received any investigational drug within 3 months prior to screening except for Chinese traditional medicine; (14) Patients did not accept to subcutaneous injection; (15) In the opinion of the investigator, patients who are not suitable to participate in this study for whatever reason must be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety indexes;HIV viral loan; | — |
Secondary
| Measure | Time frame |
|---|---|
| CD4 count;Pharmacokinetics indexes; | — |
Countries
China
Contacts
Public ContactWu Hao
Outcome results
None listed