HIV infections
Conditions
Interventions
60mg:single-dose
80mg:single-dose
5mg:single-dose
10mg:single-dose
20mg:single-dose
40mg:single-dose
Sponsors
Beijing You'an Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: All subjects should meet the following criteria before entering the trial: 1. Aged 18-60 years(including critical value), male and female; 2. Body mass index (BMI) should be higher than or equal to 0.50kg / m2 for male and body mass index (BMI) should be higher than or equal to 0.50kg / m2 for female; 3. Patients who have been diagnosed with HIV-1 infection; 4. Patients with HIV load >= 1000 copies / ml; 5. The subjects who had no family planning within 2 weeks before and 3 months after the end of the trial and agreed to take effective non drug contraceptive measures during the trial; 6. Subjects should fully understand the purpose, nature, method and possible adverse reactions of the trial, and voluntarily participate in the trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will not be allowed to enter this trial: 1. Patients in acute infection stage; 2. Confirmed AIDS patients; 3. Patients who have received antiviral treatment and / or received HIV vaccine; 4. HBsAg was (+), and / or anti HCV was (+); 5. Patients with abnormal liver function (ALT and / or ast > 3uln, or TBIL > 2uln); 6. Patients with glomerular filtration rate = ULN; 7. Patients with serious chronic diseases, metabolic diseases (such as diabetes), neurological and mental diseases; 8. Patients with previous pancreatitis; 9. Pregnant and lactating women and women of childbearing age who can not use contraception as required; 10. Patients with allergic constitution or known to be allergic to the components of the drug; 11. Subjects who had a history of smoking within 12 months before screening (average daily smoking number >= 5 cigarettes); 12. The subjects who had a history of alcohol abuse in the first 12 months (average drinking more than 14 units of alcohol per week: 1 unit = 285ml of beer, or 25ml of spirits, or 150ml of wine) or the subjects who had positive alcohol breath test before enrollment were screened; 13. Screening those who had a history of drug abuse within 12 months before enrollment or those who were positive for addictive substances before enrollment; 14. Subjects who have participated in other drug trials in the past three months (except traditional Chinese Medicine); 15. Other factors considered unsuitable for entry into the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Security Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics parameters; | — |
Countries
China
Contacts
Public ContactHaibin Yu, Hao Wu
Beijing Youan Hospital, Capital Medcial University
Outcome results
None listed