Non-nucleoside reverse transcriptase inhibitors,and other antiretroviral drugs in combination with HIV/AIDS
Conditions
Interventions
Group 1:Oral administration, once a day, ACC007 150mg + EFV placebo 1 tablet + 3TC 300mg + TDF 300mg. Blinding treatment period: Week 0 to Week 48
Open treatment period: Week 48 to Week 96
Group 2:Oral administration, once a day, EFV 600mg + ACC007 placebo 1 tablet + 3TC 300mg + TDF 300mg. Blinding treatment period : Week 0 to Week 48
Sponsors
Beijing You An Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or female between 18 to 65 years of age; 2. Diagnosed as HIV-1 infection, HIV RNA 1000 copies/ml in the 30 days prior to the enrollment and the investigator judged that the subject was eligible for ART (Antiretroviral Therapy); 3. Never received an ARV or HIV therapeutic vaccine and agreed not to start ART before the baseline; 4. Cognitive ability to understand and provide written informed consent and willingness to participate in and comply with the study protocol.
Exclusion criteria
Exclusion criteria: (1) Patients in the acute infection period of HIV-1, or have AIDS-related diseases; (2) History of drug abuse, recent history of alcohol or drug dependence; (3) Patients, in the opinion of the investigator, is likely to be hazard for his/her safety, and can't comply with the protocol; (4) Patients who participated in other drug or therapeutic device clinical trials within 30 days prior to enrollment (5) Patients who received systemic immunosuppressive therapy or immunomodulatory agents within 30 days prior to enrollment, or can not avoid using such agents during clinical trials; (6) Patients with Hepatitis C or hepatitis B virus infection with Alanine aminotransferase > 4 times of ULN; (7) Patients with Creatinine >=ULN and glomerular filtration rate (GFR) 0.7 mg/dL; male: serum creatinine <=0.7 mg/dL c= -0.411, c=-1.209 when serum creatinine <=0.7 mg/dL); (8) According to the DAIDS rating scale [2], any patient with a level 3 or 4 performance; (9) Patients have active tuberculosis at the time of screening and are undergoing treatment (Patients with active tuberculosis during the clinical trials will withdraw in order to begin anti-tuberculosis treatment); (10) Patients who took or were taking antifungal, corticosteroids, and sulfonamides and anti-tuberculosis drugs within 14 days prior to screening; (11) Patients with history of allergies or hypersensitivity to any ingredients or excipients of the study drug; (12) Pregnant or breast-feeding women; women of childbearing age who did not consider effective contraceptive measures (eg. contraceptive diaphragm; condom; intrauterine device; partner vasectomy). After screening and within 6 months after the last dose of the test drug, Female patients who were reluctant to continue to use the contraceptive method approved by the investigator. Among men with active heterosexual behavior who did not undergo vasectomy, male patients who did not take birth control measures or who were unwilling to continue using contraception during the trial period and at least 30 days after the end of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients' Percentage of HIV RNA <50 copies/ml; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes of HIV RNA log values and CD4 cell counts; 2. Patients' percentage of HIV RNA = 400 copies/ml; 3. Patients' percentage of HIV RNA <50 copies/ml; 4. Safety; | — |
Countries
China
Contacts
Public ContactHao Wu
Beijing YouAn Hospital, Capital Medical University
Outcome results
None listed