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

NCT ID: NCT06830668

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2026-12-31

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.

Conditions

HIV Infection; HIV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AIDS patients who discontinued NNRTI for more than 90 days

HIV patients of any gender, older than 18 years of age, who have been off their prior NNRTI regimen for more than 90 days and who have an HIV-1 viral load greater than 50 copies/uL.In this study, eligible patients will restart treatment on the same day and receive B/F/TAF for one year.We will conduct follow-ups on the patients and carry out routine clinical tests.

Group Type: EXPERIMENTAL

Regimen：BIC+FTC+TAF

Intervention Type: DRUG

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

Interventions

Regimen：BIC+FTC+TAF

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Chian, Beijing Municipality, China

Countries

China

Central Contacts

Yan Zhao, PhD

Role: CONTACT

zhaoyan@chinaaids.cn

010-58900930

Facility Contacts

Yan Zhao, PhD

Role: primary

zhaoyan@chinaaids.cn

86-010-58900930

Other Identifiers

CO-US-380-7381

Identifier Type: -

Identifier Source: org_study_id