Treatment of HIV-1 infected patients who have been treated with antiretroviral drugs
Conditions
Interventions
Group A:albuvirtide intravenous drop infusion for 45 min (dosage 1)
Group B:albuvirtide intravenous push infusion for 0.5 min (dosage 2)
Group C:albuvirtide intravenous push infusion for 3 min (dosage 3)
Sponsors
The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. No gender limit, healthy subjects aged 18-55 years (including 18 and 45 years, until the date of signing the informed consent form). 2. Weight>=50kg for males,>=45kg for females. BMI 19-26 kg/m^2 (including 19 and 26 kg/m^2). 3. Subjects and their partners agree to comply with the specified requirements for contraception and sperm and egg donation during the trial and for 3 months after drug administration. Ensure that one or more non-drug sexual contraceptive measures are used in sexual life from 2 weeks before screening to 1 month after the last administration of medication. 4. The subjects voluntarily sign the informed consent before the trial, and fully understand the study content, process, and possible adverse reactions; Willing to participate and complete the study according to protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic to or have an allergic constitution to Eberviride for injection (such as allergic to two or more drugs, foods or pollens); 2. Patients who have difficulty in intravenous drug administration/blood collection or have a history of fainting needle and fainting blood; 3. Those who have a history of drug abuse in the past five years or have used drugs in the three months prior to screening, or who have tested positive for drug abuse; 4. Those who smoked more than 5 cigarettes per day in the 3 months before screening, or could not stop using any tobacco products during the test; 5. Those who consumed an average of more than 14 units of alcohol per week in the three months prior to screening (1 unit of alcohol ˜360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine), or who could not abstain from alcohol during the test period, or who tested positive for alcohol blood; 6. Patients who have used any drug that inhibits or induces CYP3A metabolic enzyme in liver within 30 days prior to screening (e.g., inducers -- barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; Inhibitors -- ketoconazole, itraconazole, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines); 7. Use of any prescription drugs, over-the-counter drugs or Chinese herbs and health products in the 14 days prior to screening; 8. Those who received vaccination within 4 weeks prior to screening or were scheduled to receive vaccination during the study period; 9. Eating or drinking dragon fruit, mango, grapefruit, star fruit or food or drink prepared from it, or food or drink containing xanthine, caffeine or alcohol (including chocolate, tea, coffee, cola, cocoa, etc.), or other special diet affecting the absorption, distribution, metabolism and excretion of drugs within 48 hours before check-in; 10. Those who have special dietary requirements during the trial and cannot follow the diet provided and corresponding regulations; 11. Diseases or factors with previous or existing clinical abnormalities that the investigator considers to be clinically significant, including but not limited to neurological, cardiovascular, blood, liver, kidney, gastrointestinal, respiratory, metabolic, endocrine, immune, skeletal or other factors; 12. Patients with abnormal vital signs, physical examination, laboratory examination, 12-lead electrocardiogram and chest radiograph during the screening period and judged by the investigator to have clinical significance; 13. During the screening period, serum virology test was positive for hepatitis B surface antigen or e antigen, hepatitis C antibody, treponema pallidum antibody and human immunodeficiency virus (HIV) antibody; 14. Patients who have tested positive for pregnancy during the screening or baseline period or who are breastfeeding; 15. Patients who had a clinically significant disease or major surgical procedure within 4 weeks prior to administration, or who are expected to require major surgery during the trial period, or who have undergone surgery that would affect drug absorption, distribution, metabolism, or excretion; 16. Patients who have participated in other drug clinical trials and taken drugs within 3 months prior to screening; 17. Donors with a history of blood donation or blood loss exceeding 400 mL in the 3 months prior to screening (except for physiological blood loss in females) or during the planned trial period; 18. Patie
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma drug concentration;Vital signs;Routine 12-leads electrocardiogram;Laboratory examination;Adverse events;Physical examination;Injection site reaction; | — |
Countries
China
Contacts
Public ContactHu Wei/ Ye Jun
Drug Clinical Research Center, the Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed