Skip to content

The efficacy and safety of B/F/TAF tablets replacing stable antiretroviral therapy in adolescents living with HIV-1

The efficacy and safety of B/F/TAF tablets replacing stable antiretroviral therapy in adolescents living with HIV-1

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059030
Enrollment
Unknown
Registered
2022-04-23
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-02-05

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

Conditions

AIDS

Interventions

Experimental group:Swith to BIC/F/TAF
Control group:NA

Sponsors

Beijing Ditan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Sign a written informed consent form (adolescent and/or their legal guardian); 2. 12 to 18 years old and weight >= 35kg; 3. Confirmed HIV antibody positive through western blot testing; 4. On current standard triple therapy regimens for > 48weeks, HIV RNA = 50ml/min (calculated by CKD EPI); 6. There were no clear or suspected drug resistance record to ntritabine (FTC), tenofovir (TFV) or integrase chain transtransfer inhibitor (INST), including but not limited to reverse transcriptase resistance mutations K65R and M184V/I.

Exclusion criteria

Exclusion criteria: 1. A new AIDS defining condition diagnosed within the 30 days prior to screening; 2. Participants receiving ongoing therapy contradicted to use BIC/F/TAF or participants with any known allergies to the components of BIC/F/TAF; 3. Severe hepatic impairment (Child Pugh C); 4. Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements; 5. Participants with any documented history of virological failure (confirmed VL> 200 copies/ml), or history of resistance to any nucleoside reverse transcriptase inhibitors. * The standard triple therapy regimen contained two NRTIs + NNRTI or two NRTIs +PI.

Design outcomes

Primary

MeasureTime frame
HIV-RNA;CD4+T Cell;Blood routine;Blood chemistry;Bone Mass Measurement;

Countries

China

Contacts

Public ContactFujie Zhang

Beijing Ditan Hospital, Capital Medical University

treatment@chinaaids.cn+86 13001953958

Outcome results

None listed

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