HIV/AIDS
Conditions
Interventions
Experimental Group:Tablet
it is orally administered on an empty stomach every day
Control Group:Tablet
Specification: Each tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 10mg of tenofovir alafenamide fumarate
it is orally administered with food every day
Sponsors
Beijing Ditan 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 |
|---|---|
| Participants' Percentage of HIV RNA >= 50 copies/ml; | — |
Secondary
| Measure | Time frame |
|---|---|
| Participants' percentage of HIV RNA < 50 copies/ml;Changes of CD4 cell counts;Safety; | — |
Countries
China
Contacts
Public ContactZhang Fujie
Beijing Ditan Hospital, Capital Medical University
Outcome results
None listed