HIV drug resistance
Conditions
Interventions
Quick Launch Group:BIC/FTC/TAF +AZT or LPV/r
Sponsors
The Second Hospital of Nanjing
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years and =24 weeks 3. Virological failure (ART >=24 weeks with plasma HIV RNA =1000 copies/mL, excluding reversible causes such as significant non-adherence or drug interactions) 4. Investigator's comprehensive assessment of acceptable adherence, with agreement to follow the study initiation pathway and follow-up schedule. 5. Agreement to undergo at least 48 weeks of BIC/FTC/TAF treatment plus short-term intensification (maximum 24 weeks). 6. Women of childbearing potential agree to use effective contraception. 7. Voluntary signing of written informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous use of an INSTI regimen 2. Presence of concomitant medications with known significant interactions with the study drug that cannot be substituted 3. Known allergy or intolerance to any component of the study drug 4. Baseline laboratory abnormalities: ALT >5×ULN; eGFR <30 mL/min; Hb <75 g/L; ANC <0.75×10?/L 5. Pregnancy or lactation 6. Current conditions recognized as unsuitable for rapid initiation (e.g., uncontrolled active tuberculosis, cryptococcal meningitis) 7. Severe comorbidities deemed ineligible by the investigator (e.g., malignancy, decompensated cirrhosis, severe cardiovascular disease) 8. Other conditions deemed ineligible based on the investigator's comprehensive assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 48-week virological suppression rate(<50 copies/mL); | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of HIV RNA <200 copies/mL at 48 weeks;Time to achieve a viral load of <200 copies/mL;Changes in CD4+ T Cell Count; | — |
Countries
China
Contacts
Public ContactHuzhiliang
The Second Hospital of Nanjing
Outcome results
None listed