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Clinical study of emtricitabine, tenofovir alafenamide and bictegravir, (FTC/TAF/BIC) monotherapy in HIV-infected patients with unsuppressed virus and drug-resistant mutations

Clinical study of emtricitabine, tenofovir alafenamide and bictegravir, (FTC/TAF/BIC) monotherapy in HIV-infected patients with unsuppressed virus and drug-resistant mutations

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200065826
Enrollment
Unknown
Registered
2022-11-16
Start date
2022-11-07
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS

Interventions

Oral administration of bicentenol tablet group:N/A

Sponsors

Infectious of Department, Nanjing Second Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meeting the Diagnostic Criteria for HIV/AIDS Infection (WS293-2019); 2. Aged >= 18 years; 3. HIV RNA VL > 1000 copies /mL; 4. HIV drug resistance mutations were detected, but not M184V/I and K65N/R mutations at the same time; 5. Glomerular filtration rate (eGFR) >= 30mL/min/1.73m2 (calculated by CKD-EPI formula).

Exclusion criteria

Exclusion criteria: 1. Integrase inhibitor resistance was previously identified; 2. Pregnant or lactating women; 3. The subject has other diseases and needs to take other drugs that interact with B/F/TAF, so B/F/TAF should be prohibited or the dosage should be adjusted, and the drug cannot be stopped; 4. Participating in other interventional clinical studies; 5. The person who is known to be allergic to the drug component; 6. Serious comorbidities or underlying diseases; 7. Suspected or confirmed history of alcohol and drug abuse; 8. Those who are not considered suitable to participate in the clinical trial by the investigator (e.g. weak, poor compliance, etc.).

Design outcomes

Primary

MeasureTime frame
CD4 count;HIV viral load;

Countries

China

Contacts

Public ContactYaling Chen

Infectious of Department, Nanjing Second Hospital

yl_chen85@126.com+86 13851815946

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026