Clinical trial NCT06830668: Same-Day Restart of B/F/TAF in HIV Patients After NNRTI Discontinuation
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: HIV Infection
HIV
Keywords: HIV
HIV Infection
Lead sponsor: National Center for AIDS/STD Control and Prevention, China CDC
Sponsor class: OTHER_GOV
Collaborators: name: Gilead Sciences
First posted: 2025-02-17
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

••Patients who are pregnant.

* 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 have historic resistance test indicating drug resistant to BIC or baseline resistance test indicating resistance to BIC.
* Patients who are psychiatric illness or active tuberculosis co-infection.

Primary outcomes:
measure: The efficacy of re-initiation of B/F/TAF
timeFrame: From enrollment to the end of treatment at 24 weeks
Secondary outcomes:
measure: Drug resistance status
timeFrame: From enrollment to the end of treatment at 48 weeks
measure: The reasons for discontinuation of prior therapy
timeFrame: From enrollment to the end of treatment at 1 week
measure: The efficacy of B/F/TAF
timeFrame: From enrollment to the end of treatment at Week 12, Week24 and Week 48
measure: The persistence on B/F/TAF .
timeFrame: From enrollment to the end of treatment at 48 weeks
measure: The changes in parameters of quality of life and treatment satisfaction
timeFrame: From enrollment to the end of treatment at Week24 and Week 48
measure: The safety and tolerability on B/F/TAF
timeFrame: From enrollment to the end of treatment at 48 weeks
measure: The emergence of drug resistance
timeFrame: From enrollment to the end of treatment at 48 weeks
Other outcomes:
Locations:
city: Chian
country: China
facility: National Center for AlDS/STD Control and Prevention,China CDC,NO.155, Changbai Road,Changping District,Beijing
state: Beijing
Study officials:
References: