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NCT06830668

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

Not yet recruiting Phase 4 Last updated 17 February 2025
What this trial tests

Phase 4 trial testing Regimen:BIC+FTC+TAF in HIV Infection in 250 participants. Not yet recruiting.

Timeline
28 February 2025
Primary endpoint
31 December 2026
31 December 2026

Quick facts

Lead sponsorNational Center for AIDS/STD Control and Prevention, China CDC
PhasePhase 4
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment250
Start date28 February 2025
Primary completion31 December 2026
Estimated completion31 December 2026
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

National Center for AIDS/STD Control and Prevention, China CDC — full company profile →

Who can join

18 and older, any sex, with HIV Infection or HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for HIV Infection

Currently open trials in the same condition.

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

Trials by the same sponsor.

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Data sources for this page

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