Same-Day Restart of B/F/TAF in HIV Patients After NNRTI Discontinuation
A legfontosabb adatok
- Hol
- Chian (Kína)A helyszín megnézése
- Fázis
- 4. fázis
AI-kivonat: kiket keres a vizsgálat
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat olyan HIV-vel élő felnőtteket keres, akik több mint 90 napja abbahagyták az NNRTI-alapú kezelést. Ugyanazon a napon újraindítják a B/F/TAF kezelést.
- Életkor
- 18 év vagy idősebb
- Nem
- Minden nem részt vehet.
- A betegség stádiuma
- HIV-1 vírusterhelés 50 copies/uL felett.
- Korábbi kezelés
- Több mint 90 napja abbahagyott korábbi NNRTI-alapú kezelés.
- Biomarker vagy leletérték
- Nincs ismert vagy feltételezett rezisztencia a BIC (bictegravir) iránt.
A részvétel fő kizáró okai
- Terhesség
- Súlyos májkárosodás (Child-pugh C stádium) vagy CrCl 30 alatt
- Ismert rezisztencia a BIC iránt
- Pszichiátriai betegség
- Aktív tuberkulózis-fertőzés
Gépi kiolvasás: 2026. november 9.
Helyszínek itt: Kína
- National Center for AlDS/STD Control and Prevention,China CDC,NO.155, Changbai Road,Changping District,BeijingChian, KínaNo longer taking part
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
A vizsgálat adatai
- Ki végzi
- National Center for AIDS/STD Control and Prevention, China CDC
- Azonosító
- NCT06830668
- A regiszteradat frissítve
- 2025. február 17.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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.