National Center for AlDS/STD Control and Prevention,China CDC,NO.155, Changbai Road,Changping District,Beijing
Chian, Beijing Municipality, 102206, China
NCT Number: NCT06830668
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Chian, Beijing Municipality, 102206, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
••Patients who are pregnant.
Same-day restart of "BIC+FTC+TAF" among HIV patients who experienced discontinuation from previous NNRTI-based regimens
Time frame: From enrollment to the end of treatment at 24 weeks
Evaluate the efficacy following the re-initiation of B/F/TAF as determined by the achievement of HIV-RNA undetectable (< 50 copies/ml).
Time frame: From enrollment to the end of treatment at 48 weeks
Describe drug resistance status
Time frame: From enrollment to the end of treatment at 1 week
Describe the reasons for discontinuation of prior therapy
Time frame: From enrollment to the end of treatment at Week 12, Week24 and Week 48
Evaluate the efficacy of B/F/TAF (achievement of HIV-1 RNA< 50 copies/ml and HIV-1 RNA < 200 copies/ml) among those participants rapidly restarting B/F/TAF
Time frame: From enrollment to the end of treatment at 48 weeks
Evaluate the persistence on B/F/TAF during the study period and describe the reasons for discontinuation of B/F/TAF if it happens.
Time frame: From enrollment to the end of treatment at Week24 and Week 48
Describe changes in parameters of quality of life and treatment satisfaction
Time frame: From enrollment to the end of treatment at 48 weeks
Evaluate the safety and tolerability on B/F/TAF during the study period.
Time frame: From enrollment to the end of treatment at 48 weeks
Describe the emergence of drug resistance developed during the study period.
Contact information is provided by the study sponsor or research team.
National Center for AIDS/STD Control and Prevention, China CDC
Other Gov
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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