HIV infections
Conditions
Interventions
5mg:5mg
20mg:20mg
40mg:40mg
Sponsors
Beijing You'an Hospital Afliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. 18~60 years old (including the critical value), male and female are not limited; 2. Body mass index BMI [weight (kg)/height2 (m2)] is 18.0~28.0 (including the critical value), male weight should be >= 50kg, female weight should be >=45kg; 3. Diagnosed with HIV-1 infection; 4. Those who did not plan to have children within 2 weeks prior to screening and within 3 months after the end of the trial and who agreed to use effective non-pharmacological contraception during the trial; 5. Subjects should fully understand the purpose, nature and methods of the test and the possible adverse effects and voluntarily participate in this test.
Exclusion criteria
Exclusion criteria: 1. The presence of any of the following: (1) Unexplained persistent irregular fever of 38 degree or more for >1 month; (2) Diarrhea (stools more than 3 times/day), >1 month; (3) Weight loss of 10% or more within 6 months; (4) Recurrent oral fungal infections; (5) Recurrent herpes simplex virus infection or herpes zoster virus infection; (6) Pneumocystis carinii pneumonia (PCP); (7) Recurrent bacterial pneumonia; (8) Active tuberculosis or non-tuberculous mycobacteriosis; (9) Deep fungal infection; (10) Occupational lesions of the central nervous system; (11) Dementia in young and middle-aged adults; (12) Active cytomegalovirus (CMV) infection; (13) Toxoplasma encephalopathy; (14) Malnefield basket disease; (15) Recurrent sepsis; (16) Kaposi's sarcoma, lymphoma; 2. Patients who have received antiviral therapy and/or HIV vaccination; 3. HBsAg of (+), and/or anti-HCV of (+); 4. Abnormal liver function (ALT/AST>3XULN, or TBIL2XULN); 5. Creatinine clearance<70mL/min (Equation of calculation: Cockcroft-Gault); 6. Existing severe chronic disease, metabolic disease (such as diabetes), neurological and psychiatric disease; 7. History of pancreatitis; 8. Regnant, lactating women and women of childbearing age who cannot use contraception as required; 9. People with allergies or known allergies to the ingredients of this medicine; 10. People with a history of smoking within 12 months before screening (the average number of cigarettes smoked per day is 35.); 11. People with a history of alcoholism within 12 months before screening(Drink N14 units of alcohol per week on average: 1 unit = 285mL of beer, or 25mL of spirits, or 150mL of wine) or positive alcohol breath test before enrollment; 12. People with have a history of drug abuse within 12 months before screening or those who tested positive for addictive substances before enrollment; 13. Participated in other drug trials within 3 months before screening; 14. The investigator believes that the subject has other conditions that are not suitable for participating in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Security Index;Pharmacokinetics parameters; | — |
Countries
China
Contacts
Public ContactHaibin Yu, Hao Wu
Beijing You'an Hospital Afliated to Capital Medical University
Outcome results
None listed