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

NCT06773754 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-01-14

No results posted yet for this study

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.

Conditions

  • Virally Suppressed People With HIV

Interventions

OTHER

Five-days-On and Two-days-Off

Take Fixed-Dose Combination of Bictegravir/Emtricitabine/Tenofovir alafenamide five days a week (Five-days-On and Two-days-Off)

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-14
Primary Completion
2023-09-01
Completion
2025-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06773754 on ClinicalTrials.gov