Actively Recruiting
Good-first: a Multicohort Study of B/F/TAF As First-line ART in a Public Hospital in Eastern China
Led by Affiliated Hospital of Nantong University · Updated on 2024-10-01
630
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Affiliated Hospital of Nantong University
Lead Sponsor
N
Nantong Third Peoples Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research 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 adults newly diagnosed with HIV, including those with advanced disease. The study addresses limited clinical data and cost concerns related to B/F/TAF, involving 630 patients divided into six cohorts based on diagnosis time and treatment regimen. It is a multicohort observational study conducted in China at the Designated Hospital for HIV/AIDS Treatment of Nantong City. Participants include both prospective patients initiating B/F/TAF between July 2024 and June 2025 and retrospective patients previously treated with either tenofovir+lamivudine+efavirenz (TDF+3TC+EFV) or dolutegravir/lamivudine (DTG/3TC) from January 2020 to June 2023. The study compares clinical outcomes and cost-effectiveness across these groups. The ART regimens are taken once daily with specified tablet doses for each treatment group. Participants will be monitored over 48 weeks with data collected from electronic health records and patient-reported outcomes. Assessments include viral load suppression, CD4 count changes, immune recovery, treatment adherence, adverse events, quality of life, and mental and cardiovascular health. Cost data and modeling will evaluate long-term economic outcomes. The study includes up to 104 weeks of monitoring for treatment discontinuation and adverse events.
CONDITIONS
Brief Title
Good-first: B/F/TAF As First-line ART
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (≥18 years) diagnosed with HIV/AIDS, ART-naive, from July 2024 to June 2025 (prospective) or January 2020 to June 2023 (retrospective).
- Eligible for ART initiation with B/F/TAF or previously treated with TDF+3TC+EFV or DTG/3TC.
- Willing to adhere to study procedures and follow-up visits or have complete electronic health records (EHRs).
You will not qualify if you...
- Severe renal impairment (creatinine clearance < 50 mL/min).
- Hepatitis B co-infection or severe hepatic impairment (Child-Pugh Class C).
- Active tuberculosis (TB).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 104 weeks from ART initiation or retrospective data period
Participants who initiate antiretroviral therapy (ART) or have retrospective data are observed for treatment effectiveness, health status, and quality of life.
Assessments at baseline, and at 12, 24, and 48 weeks; additional monitoring up to 104 weeks
Trial Site Locations
Total: 1 location
1
Nantong Third Peoples Hospital
Nantong, Jiangsu, China, 226006
Actively Recruiting
Research Team
G
Gang Qin, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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