HIV infection
Conditions
Interventions
A:D1-D14 were given daily oral ainuovirine and D8-D14 plus fluconazole
B:D1-D14 were given daily oral fluconazole and D8-D14 plus ainuovirine
Sponsors
Guangzhou Eighth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: (1) Voluntarily participate in the study and provide signed and dated informed consent; (2) male or female aged 18 to 55 years at screening visits; (3) Male subjects weigh at least 50 kg and female subjects weigh at least 45 kg. BMI in the range of 19.0 ~ 26.0 kg/m2 (including cut-off value); (4) The investigator judged that the subject was in good health and had no clinically significant abnormalities based on past medical history, vital signs, physical examination, laboratory examination, electrocardiogram, etc.; (5) In the case of female subjects: a. non-childbearing potential, including subjects with surgical sterilization (documented tubal ligation, hysterectomy, or bilateral salpingectomy), and subjects who have been in continuous amenorrhea after menopause for more than 12 months at screening visit (confirmed menopause by follicle-stimulating hormone (FSH) level =40 IU/L); b. If there is a fertility potential Stanozol, must be non-pregnant, non-lactating, and must agree to use 2 highly effective methods of contraception (1 of which is a highly effective method) 14 days before administration, during the study, and 3 months after administration; 1 must be a barrier method); c. Negative serum human chorionic gonadotropin (hCG) test result at screening visit and D-1; In the case of male subjects, their female partners of childbearing potential must agree to use appropriate contraception 14 days before administration, during the study period, and 3 months after administration; Also, male subjects are not allowed to donate sperm during this period; (6) Be willing to comply with visits, research treatments, laboratory tests, and other research-related procedures and requirements as prescribed by the research protocol.
Exclusion criteria
Exclusion criteria: (1) hypersensitivity to the investigational drug or its excipients, or a history of severe allergies (including any food allergies or drug allergies); (2) any previous disease or physical condition such as a major central nervous system, respiratory, cardiovascular, digestive, hematological, endocrinian, musculoskeletal, urinary or neoplastic disease, or any existing acute illness, or other disease or physical condition that, in the judgment of the Investigator, may affect the study or pose an unacceptable risk to the subject; (3) positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis C antibody (HCVAb) and the result of HCV RNA is greater than the lower limit of the detection method, or positive for treponemal antibody or positive for HIV antibody; (4) Resting systolic blood pressure (SBP) > 140 or 90 or 100 or 450 ms for men or 470 ms > for women; (7) Serum aspartate aminotransferase (ALT) or alanine aminotransferase (AST) > upper limit of normal value (ULN); (8) Glomerular filtration rate (GFR) estimated according to CKD-EPI creatinine formula<90ml/min/1.73m2; (9) Known or suspected history of drug abuse (e.g., morphine, methamphetamine, ketamine, methylenedioxyamphetamine, tetrahydrocannabinolic acid, cocaine, etc.), or positive drug screening test; (10) Alcohol abuse within 1 year prior to screening (drinking more than 21 standard units per week, 1 standard unit containing 14g of alcohol, such as 5% beer 360ml, 40% spirits 45ml, 12% wine 120ml), or positive alcohol breath test; (11) Smoked more than 5 cigarettes per day for 3 months prior to screening, or could not comply with the study period anti-smoking regulations; (12) Use of any drug that inhibits or induces liver drug-metabolizing enzymes within 30 days prior to the screening period; Those who have taken foods or beverages (such as grapefruit, etc.) containing enzymes that induce or inhibit liver metabolism within 7 days before the start of the trial; Disagreement or no guarantee of not taking between 48 hours prior to the first dose of the trial and completion of the last pharmacokinetic blood sample collection take any food or drink that contains or metabolizes caffeine or xanthines (e.g. coffee, tea, chocolate); (13) Have received any vaccine within 30 days prior to screening, or plan to receive any during the study Vaccine; (14) No medications, including prescription and over-the-counter drugs (excluding topical eye/nose drops and creams that do not pose a risk of systemic exposure), vitamins (excluding conventional vitamins), health care, cannot be avoided from 14 days prior to administration (or 5 half-lives if the drug used has a 5 half-lives of more than 14 days) to the last visit Goods and Chinese herbal medicines; (15) Those who received any investigational drug treatment or participated in any drug/investigational device trial within 3 months prior to administration; (16) have undergone major surgical procedures within 30 days prior to administration, or are scheduled to undergo major surgical procedures during the study period; (17) is currently pregnant or nursing, or intends to become pregnant during the study; (18) Have donated blood or lost = 400 ml within 3 months prior to screening; (19) Those who are judged by the investigator to have other serious sys
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;tolerability; | — |
Countries
China
Contacts
Public ContactLinghua Li
Guangzhou Eighth People's Hospital
Outcome results
None listed