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Clinical study of switching to Bictegravir/emtricitabine/tenofovir alafenamide single-tablet therapy in HIV-infected patients with viral suppression and historical drug resistance mutations

Clinical study of switching to Bictegravir/emtricitabine/tenofovir alafenamide single-tablet therapy in HIV-infected patients with viral suppression and historical drug resistance mutations

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063461
Enrollment
Unknown
Registered
2022-09-07
Start date
2022-09-06
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

AIDS

Interventions

Intervention group:Bicarbonate propionol tablets

Sponsors

Infectious of Department, Nanjing Second Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meeting "the Diagnostic Criteria for HIV/AIDS Infection" (WS293-2019); 2. Aged >= 18 years; 3. Failure of previous treatment with the national free first-line ART regimen (sustained HIV RNA VL >= 200 copies/ml for 24 weeks, or >= 200 copies /ml again after reaching HIV RNA VL = 30 ml/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 RNA Viral Load;

Countries

China

Contacts

Public ContactHu Zhiliang

Infectious of Department, Nanjing Second Hospital

huzhiliangseu@163.com+86 15951857895

Outcome results

None listed

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