AIDS
Conditions
Interventions
Group 1:Albuvirtide once a week + LPV/r
Group 2:LPV/r + TDF+ 3TC
Sponsors
Beijing YouAn Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
16 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 16 to 60 years old; 2. Previously documented HIV infection on standard antibody-based test; 3. Previous antiretroviral therapy (ART) with NRTIs/NNRTIs for more than 6 months; 4. HIV RNA=1000 copies/ml; 5. In good healthy condition by physical examination, biochemistry, hematology and urinalysis test, and electrocardiogram etc., without serious liver and renal damages; 6. Fully understand the purpose, characteristics, procedures of the trial, and the potentially adverse events which might occur during study; willing and able to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with acute HIV infection,or with AIDS-related disease, such as severe opportunistic infection or tumors; 2. Previously received any protease inhibitors, HIV fusion inhibitors, HIV vaccines, or received other investigational drugs within 3 months; 3. Co-treatment against hepatitis virus; 4. Having abnormal values at screening as follows: Hemoglobin3-fold upper limit of normal value, Total bilirubin >2-fold upper limit of normal value, Creatinine >upper limit of normal value, Creatine phosphokinase >2-fold upper limit of normal value; 5. With allergic constitution, or allergic history of the investigational drug and ART drugs; 6. With serious chronic disease, metabolic disease (such as diabetes), mental disorder and nervous disease; 7. Had a history of hemophilia A or B; 8. Alcohol abuse or drug abuse; 9. Pregnant women, breast feeding women, and women in child-bearing age disagreed with use of birth control; 10. Unsuitable to participate in this study in the opinion of the site investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety indexes;HIV RNA; | — |
Secondary
| Measure | Time frame |
|---|---|
| CD4 count; | — |
Countries
China
Contacts
Public ContactHao Wu
Beijing YouAn Hospital, Capital Medical University
Outcome results
None listed