HIV infection
Conditions
Interventions
Intervention Goup:tenofovir + lamivudine + efavirenz
Control Group:no
Sponsors
China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with early HIV infection (acute/recent stage): the term acute stage refers to a negative finding or uncertain of the HIV antibody, but the HIV RNA >10000 copies/ml; the term recent stage refers to a positive finding of the HIV antibody at the enrollment, but there is certain evidence of negative findings of HIV antibody in past six months; 2. 18-65 years old; 3. Subjects who signed the informed concent and would like to follow up; 4. Subjects with no plan to resettle during the trial; 5. Treatment na?ve patients.
Exclusion criteria
Exclusion criteria: 1. Patients with active opportunistic infections or HIV-related malignancies at enrollment; 2. Patients with opportunistic infections in the past three months and unstable in the past two weeks before enrollment; 3. Patients with active autoimmune diseases; 4. Patients with definite or suspected diagnosis of acute hepatitis or chronic active hepatitis in the past 30 days before enrollment; 5. Patients whose HGB 2 times of ULN, Cr>1.5 times of ULN, AST/ALT/AKP>2 times of ULN, TBIL>2 times of ULN, CK>2 times of ULN; 6. Patients currently with CKD or CCR<60 ml/min; 7. Patients currently with acute or chronic pancreatitis; 8. Patients in use of other investigational products or immunomodulator in the past 30 days before enrollment; 9. Pregnant or breastfeeding women; 10. Drug addicts; 11. Patients with serious mental and neurological diseases; 12. Patients with mental retardation or cannot communicate with their doctors; 13. has a history of alcoholism and cannot be terminated; 14. Patients with severe peptic ulcer or have difficulty to swallow drugs; 15. Patients with used within 3 months before the start of treatment with severe nervous system toxicity, toxicity, pancreas or cell potential toxicity drugs, or when need to use the drugs; 16. Patients who did not stop the nephrotoxic drugs (eg. aminoglycoside antibiotics, type IV amphotericin, cidofovir, type IV Pentamidine, cisplatin), adefovir or probenecid at least 30 days before enrollment; 17. Patients who are takine the following drugs: astemizole, cisapride, ergot derivatives, hydroxyurea, midazolam, Sally amine, triazolam, vincristine, zalcitabine, ribavirin, adriamycin, voriconazole, St. John's wort or any drugs forbidden to be combined with antiviral drugs; 18. Not of Chinese nationality; 19. Weight<40kg. CCr={[(140 – age) ×weight]/[72×SCr(mg/dl)]} ×(0.85 if female)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CD4 and CD8 T cells;HIV viral load; | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug resistance mutation;Naive and memory T cell; | — |
Countries
China
Contacts
Public ContactHong Shang
Outcome results
None listed