Clinical Research Directory

Fixed-Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide Taken as 5 Days Per Week

Sponsor: National Taiwan University Hospital

Summary

The goal of this clinical trial is to learn if fixed-dose combination of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) taken as 5 days per week (5/7, FOTO group) works well as continuous therapy as 7 days per week (7/7, Daily group) in HIV-1-Infected participants who are virally suppressed. The main questions it aims to answer are: 1. Do the lowest concentrations of BIC at baseline, Week 4, 28, and 52 in the FOTO group achieve the adequate BIC level to control HIV infection? 2. Do the HIV viral loads at Week 4, 28, and 52 remain suppressed in the FOTO group? Researchers will compare FOTO group to Daily group to see if FOTO group can achieve the adequate BIC levels and HIV viral suppression. Participants will: 1. Take fixed-dose BIC/FTC/TAF 5 days a week or everyday Blood sampling for the lowest concentrations of BIC at baseline, Week 4, 28, and 52 2. Blood sampling for HIV viral loads every 3 months for one year after the enrollment 3. Keep a diary of their drug compliance. 4. Be invited to change to take fixed-dose BIC/FTC/TAF 5 days a week after Week 52 if they are randomised to Daily group initially. 5. Be followed for 2 years after the enrollment.

Official title: Open-Label Pharmacokinetic Study of Fixed-Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide Taken as 5 Days Per Week (5/7) Versus Continuous Therapy as 7 Days Per Week (7/7) in HIV-1-Infected Participants Who Are Virally Suppressed

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