AIDS
Conditions
Interventions
A:LPV/RTV and Albuvirtide at a dose of 160mg for 46 days
B:LPV/RTV and Albuvirtide at a dose of 320mg for 46 days
Sponsors
Beijing YouAn Hospital, Capital medical university
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 to 50 years old; 2. Previously documented HIV infection on standard antibody-based test; 3. HIV RNA >=5000, =350/ul; 5. In a good healthy condition by physical examination, biochemistry, hematology and urinalysis test, chest X ray examination, B type ultrasonic examination and electrocardiogram etc., without serious liver and renal damages; albumin and other items are in normal range; 6. Naive to antiretroviral therapy or have stopped treatment for at least half a year; 7. Body weight = 40 kg with BMI from 18 to 27 kg/m2; 8. Willingness to abstain from alcohol during the trial; 9. Fully understand the purpose, characteristics, procedures of the trial, as well as the adverse event which might occur during study; Willing and able to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with acute HIV infection; 2. With severe opportunistic infection or tumors; 3. ALT is 2-fold more than upper limit of normal value, or Creatinine is over upper limit of normal value, or other items are obviously abnormal; 4. With serious chronic disease, metabolic disease (such as diabetes), mental disorder and nervous disease; 5. Had a history of pancreatitis; 6. Had a history of hemophilia A or B; 7. With allergic constitution, or allergic history of the investigational drug and LPV/RTV; 8. Pregnant women, breast feeding women, and women in child-bearing age disagreed with use of birth control; 9. Alcohol abuse or drug abuse; 10. Received any other investigational drugs, HIV fusion inhibitors, or HIV vaccine within 3 months; 11. Received other anti-HIV medicine within half a year before screening; 12. Had a fever with 3 days prior to study entry; 13. Unsuitable to participate in this study in the opinion of the site investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics indexe; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety indexes;HIV RNA;CD4 count; | — |
Countries
China
Contacts
Public ContactHao Wu
Outcome results
None listed