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

NCT06830668 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: CO-US-380-7381
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Keywords

HIV; HIV Infection

Outcome Measures

Primary Outcomes (1)

• The efficacy of re-initiation of B/F/TAF

  Evaluate the efficacy following the re-initiation of B/F/TAF as determined by the achievement of HIV-RNA undetectable (\< 50 copies/ml).

  From enrollment to the end of treatment at 24 weeks

Secondary Outcomes (7)

• Drug resistance status

  From enrollment to the end of treatment at 48 weeks

• The reasons for discontinuation of prior therapy

  From enrollment to the end of treatment at 1 week

• The efficacy of B/F/TAF

  From enrollment to the end of treatment at Week 12, Week24 and Week 48

• The persistence on B/F/TAF .

  From enrollment to the end of treatment at 48 weeks

• The changes in parameters of quality of life and treatment satisfaction

  From enrollment to the end of treatment at Week24 and Week 48

Study Arms (1)

AIDS patients who discontinued NNRTI for more than 90 days

EXPERIMENTAL

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.

Drug: Regimen：BIC+FTC+TAF

Interventions

Regimen：BIC+FTC+TAF DRUG

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

AIDS patients who discontinued NNRTI for more than 90 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• •Patients who are pregnant.
• 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.

Sponsors & Collaborators

• National Center for AIDS/STD Control and Prevention, China CDC: lead
• Gilead Sciences: collaborator

Study Sites (1)

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

Chian, Beijing Municipality, 102206, China

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Yan Zhao, PhD

CONTACT

010-58900930; zhaoyan@chinaaids.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2025
• First Posted: February 17, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)