NCT06773754Active, not recruiting
Fixed-Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide Taken as 5 Days Per Week
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
Source: ClinicalTrials.gov · Last updated 14 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 8 Jan 2025
- Start date
- 14 Jun 2022
- Primary completion date
- 1 Sept 2023
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- HIV
- NCT number
- NCT06773754
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 14 Jun 2022 to the primary completion date, 1 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- PLWH with concurrent use of medications known to pharmacokinetically interact with BIC
Other illness
- PLWH with a history of intolerance to antiretroviral regimens containing an integrase inhibitor, ETC/lamivudine, and tenofovir disoproxil fumarate/TAF
- PLWH with a history of genotypic resistance to integrase inhibitors or TFV
Who the study is looking for
- PLWH aged 20 years or more
- PLWH with virological suppression (\<50 copies/mL) for 6 months or more
- PLWH who have received coformulated BIC/FTC/TAF for at least 2 weeks or more
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.