Using B/F/TAF as a first-line treatment for HIV
Good-first: a Multicohort Study of B/F/TAF As First-line ART in a Public Hospital in Eastern China
This study is testing if a new HIV treatment called B/F/TAF works well as a first option for people who are newly diagnosed with the virus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 630 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Affiliated Hospital of Nantong University Academic / other |
| Locations | 1 site (Nantong, Jiangsu) |
| Trial ID | NCT06619288 on ClinicalTrials.gov |
What this trial studies
This multicohort study aims to gather real-world evidence on the use of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as a first-line antiretroviral therapy (ART) for newly diagnosed HIV patients. Conducted at the Affiliated Hospital of Nantong University and Nantong Third Peoples Hospital in China, the study will involve 630 patients divided into six cohorts, with both prospective and retrospective data collection. The study will assess clinical outcomes, treatment adherence, and quality of life over 48 weeks, addressing the cost-effectiveness of B/F/TAF compared to other ART regimens. Data will be collected through electronic health records and patient-reported outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are newly diagnosed with HIV/AIDS and ART-naive.
Not a fit: Patients with severe renal impairment, hepatitis B co-infection, or active tuberculosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and cost-effectiveness of B/F/TAF as a first-line treatment for HIV, potentially improving patient outcomes.
How similar studies have performed: While there is limited clinical data on B/F/TAF for this specific patient group, similar studies have shown promise in evaluating first-line ART regimens.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults (≥18 years) diagnosed with HIV/AIDS, ART-naive, from July 2024 to June 2025 (prospective) or January 2020 to June 2023 (retrospective). 2. Eligible for ART initiation with B/F/TAF or previously treated with TDF+3TC+EFV or DTG/3TC. 3. Willing to adhere to study procedures and follow-up visits or have complete electronic health records (EHRs). Exclusion Criteria: 1. Severe renal impairment (creatinine clearance \< 50 mL/min). 2. Hepatitis B co-infection or severe hepatic impairment (Child-Pugh Class C). 3. Active tuberculosis (TB).
Where this trial is running
Nantong, Jiangsu
- Nantong Third Peoples Hospital — Nantong, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Gang Qin, MD, PhD
- Email: tonygqin@ntu.edu.cn
- Phone: +86-189-1228-8106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.