Non-nucleoside reverse transcriptase inhibitors,and other antiretroviral drugs in combination with HIV/AIDS
Conditions
Interventions
75mg:150mg once a day oral administration of ACC007 tablets with 75mg specification for 10 consecutive days
75mg:300mg once a day oral administration of ACC007 tablets with 75mg specification for 10 consecutive days
Sponsors
Beijing You An Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Subjects should fully understand the investigational nature,methods,and possible reactions of this study ,comply with the requirements listed in the inforemd consent and voluntarily signed informed consent; 2. Male or female between 18 to 60 years of age; 3. Subjects are diagnosed as HIV-1 infection and never received HIV therapeutic vaccine or ARV treatment before screening; 4. Viral load >5000copies/mL (RNA PCR), CD4 cell count >200/mL (BD flow cytometry) when screening; 5. A subjects with body weight=40kg and body mass index(BMI)between 18 to 27kg/m2 BMI=weight(kg)/{height(m)}2. 6. Subjects agree to not take any antiretroviral treatment before the baseline visit, and agree to transfer to receive first-line antiviral treatment under the national free antiviral treatment system after the end of ACC007 administration; 7. No birth plan within six months.For females of child-bearing potential only; (1) negative response of pregnancy test at the time of screening; (2) no sexually active at least 6 weeks or have practiced a reliable method of birth control (for example,use of oral contraceptives or levonorgestrel; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abatinence) for at least 6 weeks prior to screening. For males; Agree to continue to use a reliable method of birth control during the study. 8. Under to comprehensive physical examination (including general physical examination, hematuria routine, biochemical tests of blood, coagulation, chest X-ray, B ultrasound and ECG, etc.) liver and kidney function and the rest of the indicators are in the normal range.
Exclusion criteria
Exclusion criteria: 1. Subjects in the acute infection period of HIV-1, or have AIDS-related diseases at the time of enrollment, or opportunistic infections occurred within 3 months and condition remains unstable within 4 weeks before enrollment; 2. A subjects with a history of allergies to drugs (aspirin, antibiotics, etc.), or history of clincally significant allergies; 3. A subjects with clinical evidence or history of hepatic, renal, respiratory, endocrine, neurologic, immunologic, hematologic, oncologic, psychiatric, or cardiovascular disease; 4. Subjects with history of gastrointestinal disease or surgery(except simple appendectomy or repair of hernia), which can influence the absorption of the study drug; 5. Female subjects who are pregnant or nursing; 6. The value of AST or ALT is greater than 1.5 times the upper limit of the reference range; 7. A positive Hepatitis B surface antigen or positive Hepatitis C antibody at screening; 8. Subjects who have taken any prescribed medication or herbal compounds within 14 days prior to the study drug administration. In addition, subjects who have taken any over-the-counter drug or vitamin supplements within 7 days prior to the study drug administration; 9. Subjects who have received combination therapy containing any antiretroviral drugs in the sales market or under any clinical trials; 10. Subjects who have received any antiretroviral treatment within 30 days prior to baseline; 11. Patients who are taking any of the following medications; Bepridil, cisapride, midazolam, pimozide, triazolam, Ergotmedications (e.g. Wigraine, cagergot, St, Johns wort), Phenobarbitol; 12. Subjects who have participated in any other clinical trial either for investigational or marketed grugs within 8 weeks before the study drug administration; 13. Subjects who have donated or had loss of = 400ml of blood within 8 weeks prior to start of administration of study drug. 14. Subjects cannot avoid alcoholic beverages or smoking throughout the study period; 15. Subjects with history of drug abuse, or positive urine drug screening test; 16. Subjects who heavily take caffeine or caffeine-containing products, or takes grapefruit, grapefruit juice, or grapefruit-containing products; 17. Subjects who are unable to eat a standardized meal offered by the study center; 18. Systolic blood pressure outside the range of 80 to 140mm Hg,or diastolic blood pressure outside the range of 60 to 85mm Hg, or heart rate outside the range of 50 to 100 beats per minute(bpm) for females; outside and the range of 45 to 100 beats per minute (bpm) for male subjects (Blood pressure and heart rate should be taken after 10 minutes of rest); 19. Subjects who cannot swallow up to 8 uncoated table (8 mm diameter); 20. The investigator judges the subject not eligible for the study after reviewing clinical laboratory results or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerance Assessment: Adverse events, physical examination, vital signs, electrocardiogram, and laboratory tests, Pharmacokinetics Assessment: analysis of data by PK blood samples.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy assessment: logarithm of HIV-1 RNA levels and CD4+ T cell counts and percentage changes.; | — |
Countries
China
Contacts
Public ContactHao Wu
Beijing YonAn Hospital, Capital Medical University
Outcome results
None listed