Same-day restart of an HIV medicine after a stopped treatment
Tests restarting a combined HIV medicine the same day in adults who stopped earlier treatment.
Plain-language title generated from the registry record
Registry title: Same-Day Restart of B/F/TAF in HIV Patients After NNRTI Discontinuation
Key facts
- Where
- Chian, ChinaSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with HIV who stopped an NNRTI-based treatment more than 90 days ago. They restart B/F/TAF on the same day.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- HIV-1 viral load greater than 50 copies/uL.
- Earlier treatment
- Stopped a previous NNRTI-based regimen more than 90 days ago.
- Biomarker or test result
- No known or suspected resistance to BIC (bictegravir).
Main reasons for not taking part
- Pregnancy
- Severe liver impairment (Child-pugh class C) or CrCl below 30
- Known resistance to BIC
- Psychiatric illness
- Active tuberculosis co-infection
Read by machine on 12 November 2026.
Where in China
- National Center for AlDS/STD Control and Prevention,China CDC,NO.155, Changbai Road,Changping District,BeijingChian, ChinaContact: Yan Zhao, PhDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- National Center for AIDS/STD Control and Prevention, China CDC
- Trial code
- NCT06830668
- Record updated
- 17 February 2025
- Original description
In China, free first-line ART regimens typically consist of two nucleoside reverse transcriptase inhibitors (NRTIs) and a non-nucleoside reverse transcriptase inhibitor (NNRTI). As of the end of 2022, approximately 1.135 million individuals were receiving ART, achieving a coverage rate of 92.8%, largely due to participation in free treatment programs. However, around 36,000 patients have discontinued treatment, primarily due to side effects associated with Efavirenz (EFV), a common NNRTI. The challenges posed by side effects and resistance profiles of existing NNRTIs highlight the need for effective re-initiation of ART to improve overall treatment coverage. INSTIs, particularly B/F/TAF (Bictegravir/emtricitabine/tenofovir alafenamide), demonstrates effective viral suppression and a higher barrier to resistance than NNRTIs. B/F/TAF has shown efficacy in patients with resistance mutations, making it a strong candidate for same-day ART re-initiation, especially in resource-limited areas where genotypic resistance testing may be unavailable. This study aims to evaluate the feasibility and effectiveness of rapidly restarting B/F/TAF in patients with treatment interruptions from previous NNRTI regimens.Read full original descriptionShow less
Effectiveness and Persistence of Same-day Re-start with B/F/TAF Among Patients with HIV Who Experienced Discontinuation from Previous NNRTI Based Regimens in China
In China, free first-line ART regimens typically consist of two nucleoside reverse transcriptase inhibitors (NRTIs) and a non-nucleoside reverse transcriptase inhibitor (NNRTI). As of the end of 2022, approximately 1.135 million individuals were receiving ART, achieving a coverage rate of 92.8%, largely due to participation in free treatment programs. However, around 36,000 patients have discontinued treatment, primarily due to side effects associated with Efavirenz (EFV), a common NNRTI. The challenges posed by side effects and resistance profiles of existing NNRTIs highlight the need for effective re-initiation of ART to improve overall treatment coverage. INSTIs, particularly B/F/TAF (Bictegravir/emtricitabine/tenofovir alafenamide), demonstrates effective viral suppression and a higher barrier to resistance than NNRTIs. B/F/TAF has shown efficacy in patients with resistance mutations, making it a strong candidate for same-day ART re-initiation, especially in resource-limited areas where genotypic resistance testing may be unavailable. This study aims to evaluate the feasibility and effectiveness of rapidly restarting B/F/TAF in patients with treatment interruptions from previous NNRTI regimens.
Inclusion: Patients with 18 years old or above; Discontinuation of previous NNRTI based regimen for more than 90 days; No known CrCl< 30mL/min or severe hepatic impairment; No known or suspected resistance to BIC; No known pregnancy.
Exclusion: Patients who have historic resistance test indicating drug resistant to BIC or baseline resistance test indicating resistance to BIC; Patients who have abnormal liver and kidney function indicators(Child-pugh class C, CrCl< 30).Hepatitis virus co-infection does not serve as an exclusion criterion; Patients who are psychiatric illness or active tuberculosis co-infection; ••Patients who are pregnant.