HIV infections
Conditions
Interventions
A:2NRTIs (TDF+3TC)+DTG
B:2NRTIs (TDF+3TC)+EFV or LPV/r
Sponsors
Key Laboratory of AIDS Immunology of National Health and Family Planning Commission, Department of Laboratory Medicine, The First Affiliated Hospital, China Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients who initiated HAART during acute HIV infection. Acute HIV infection refers to having recent clinical manifestation, and meeting 1 of 2 criteria: 1) a negative finding or uncertain of the HIV antibody, but the HIV RNA >5000 copies/ml; 2) a positive HIV serology at enrollment, but with certain evidence of negative testing in the previous 6 months; 2. Aged 18-65 years old; 3. Male, with self-reported sexual behavior with men; 4. Subjects who signed the informed consent and would like to follow up; 5. Subjects with no plan to resettle during the trial; 6. Participants have never accept any anti-retroviral treatment before.
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. Drug addicts; 10. Patients with serious mental and neurological diseases; 11. Patients with mental retardation or cannot communicate with their doctors; 12. Patients who have a history of alcoholism that cannot be terminated; 13. Patients with severe peptic ulcer or have difficulty to swallow drugs; 14. 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; 15. 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; 16. Patients who are taking the following drugs: astemizole, cisapride, ergot derivatives, hydroxyurea, midazolam, Sally amine, triazolam, vincristine, zalcitabine, ribavirin, adriamycin, voriconazole, St. John's wort, dofetilide, pilsicainide or any drugs forbidden to be combined with antiviral drugs; 17. Not of Chinese nationality; 18. Weight<40kg. CCr (for males)=[(140 – age) ×weight]/[72×SCr(mg/dl)]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HIV viral load;CD4 T cell count; | — |
Countries
China
Contacts
Public ContactHong Shang
Key Laboratory of AIDS Immunology of National Health and Family Planning Commission, Department of Laboratory Medicine, The First Affiliated Hospital, China Medical University
Outcome results
None listed