NCT06830668Not yet recruitingPhase 4
Same-Day Restart of B/F/TAF in HIV Patients After NNRTI Discontinuation
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
Source: ClinicalTrials.gov · Last updated 17 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 26 Jan 2025
- Start date
- 28 Feb 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- National Center for AIDS/STD Control and Prevention, China CDC
- Diseases
- HIV
- NCT number
- NCT06830668
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 250
- From 28 Feb 2025 to the primary completion date, 31 Dec 2026
- 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
- Patients who have historic resistance test indicating drug resistant to BIC or baseline resistance test indicating resistance to BIC.
Other illness
- 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.
Other
- ••Patients who are pregnant.
Who the study is looking for
- 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
Age in the registry: 18 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 Center for AlDS/STD Control and Prevention,China CDC,NO.155, Changbai Road,Changping District,Beijing Coordinator of this site? Confirm its status | Chian | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.