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NCT Number: NCT06830668

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Center for AlDS/STD Control and Prevention,China CDC,NO.155, Changbai Road,Changping District,Beijing

Chian, Beijing Municipality, 102206, China

Location contact

Yan Zhao, PhD

CONTACT

[email protected]

86-010-58900930

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Regimen:BIC+FTC+TAF

Drug

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

Primary outcomes

  1. The efficacy of re-initiation of B/F/TAF

    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).

Secondary outcomes

  1. Drug resistance status

    Time frame: From enrollment to the end of treatment at 48 weeks

    Describe drug resistance status

  2. The reasons for discontinuation of prior therapy

    Time frame: From enrollment to the end of treatment at 1 week

    Describe the reasons for discontinuation of prior therapy

  3. The efficacy of B/F/TAF

    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

  4. The persistence on 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.

  5. 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

    Describe changes in parameters of quality of life and treatment satisfaction

  6. The safety and tolerability on B/F/TAF

    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.

  7. The emergence of drug resistance

    Time frame: From enrollment to the end of treatment at 48 weeks

    Describe the emergence of drug resistance developed during the study period.

Study contacts

Contact information is provided by the study sponsor or research team.

Yan Zhao, PhD

CONTACT

[email protected]

010-58900930

Sponsors and collaborators

Lead sponsor

National Center for AIDS/STD Control and Prevention, China CDC

Other Gov

Collaborators

  • Gilead Sciences

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2025
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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