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Not yet recruiting NCT06830668

Same-Day Restart of B/F/TAF in HIV Patients After NNRTI Discontinuation

Phase IV Interventional HIV Infection HIV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Regimen：BIC+FTC+TAF.
Who it may be relevant to
Registry conditions: HIV Infection, HIV. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Drug Regimen：BIC+FTC+TAF
    Same-day restart of "BIC+FTC+TAF" among HIV patients who experienced discontinuation from previous NNRTI-based regimens

Primary outcome measures

  • The efficacy of re-initiation of B/F/TAF [Time frame: From enrollment to the end of treatment at 24 weeks]
Secondary outcome measures (7)
  • Drug resistance status [Time frame: From enrollment to the end of treatment at 48 weeks]
  • The reasons for discontinuation of prior therapy [Time frame: From enrollment to the end of treatment at 1 week]
  • The efficacy of B/F/TAF [Time frame: From enrollment to the end of treatment at Week 12, Week24 and Week 48]
  • The persistence on B/F/TAF . [Time frame: From enrollment to the end of treatment at 48 weeks]
  • The changes in parameters of quality of life and treatment satisfaction [Time frame: From enrollment to the end of treatment at Week24 and Week 48]
  • The safety and tolerability on B/F/TAF [Time frame: From enrollment to the end of treatment at 48 weeks]
  • The emergence of drug resistance [Time frame: From enrollment to the end of treatment at 48 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • National Center for AlDS/STD Control and Prevention,China CDC,NO.155, Changbai Road,Changp — Chian

Identifiers

NCT: NCT06830668 · CO-US-380-7381

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗