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Post-Authorization Study to Evaluate the Safety and Effectiveness of Biktarvy in Patients with Human Immunodeficiency Virus-1(HIV-1) infection in China

Post-Authorization Study to Evaluate the Safety and Effectiveness of Biktarvy in Patients with Human Immunodeficiency Virus-1(HIV-1) infection in China

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100042380
Enrollment
Unknown
Registered
2021-01-21
Start date
2021-01-20
Completion date
Unknown
Last updated
2022-10-31

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

Conditions

HIV-1

Interventions

case series:Nil

Sponsors

Guangzhou Eighth People's Hospital / Beijing Ditan Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.HIV-1 infection; 2.who have been informed of all pertinent aspects of the study and have voluntarily signed an informed consent form (patients 18 years of age or older); 3.Initiating treatment with B/F/TAF in accordance with the approved product information.

Exclusion criteria

Exclusion criteria: 1.Patients treated with Biktarvy? outside of the approved prescribing information in China; 2.Concurrent participation in a clinical trial of HIV treatment (except trials not testing investigational medicinal products); 3.Patients who have a contraindication as indicated under prescribing information; 4.Patients planning on leaving the country for an extended period during the study period; 5.Patients deemed by the investigator to be unlikely to maintain regular medical follow-up through at least 48 weeks.

Design outcomes

Primary

MeasureTime frame
To assess rates of adverse events (AEs) and serious AEs (SAEs);To evaluate HIV-1 RNA suppression, defined as HIV-1 RNA <200 copies/mL, at 12 months after initiating or switching to B/F/TAF;

Countries

China

Contacts

Public ContactEric Wang
eric.wang7@gilead.com+86 21 38934472

Outcome results

None listed

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