Last reviewed · How we verify
NCT06830668
Same-Day Restart of B/F/TAF in HIV Patients After NNRTI Discontinuation
Phase 4 trial testing Regimen:BIC+FTC+TAF in HIV Infection in 250 participants. Not yet recruiting.
31 December 2026
Quick facts
| Lead sponsor | National Center for AIDS/STD Control and Prevention, China CDC |
|---|---|
| Phase | Phase 4 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 250 |
| Start date | 28 February 2025 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Regimen:BIC+FTC+TAF — full drug profile →
Conditions studied
- HIV Infection — all drugs for HIV Infection →
- HIV — all drugs for HIV →
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.
Verify or expand the search:
- PubMed search for NCT06830668
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for HIV Infection
Currently open trials in the same condition.
- NCT06900829 — #AWARE.HIV Europe: Supporting Healthcare Professionals to Find Undiagnosed HIV in European Hospitals: An Effectiveness-i · NA · recruiting
- NCT06908252 — MAPS PrEP Van Study · Phase 4 · recruiting
- NCT07042945 — MK-4646 Multiple Dose Trial in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-4646-003) · Phase 1 · recruiting
- NCT06716450 — Multiplo Tp/HIV Self-Test · NA · recruiting
- NCT07086989 — Cardiovascular Risk in Children With Chronic Conditions Study · recruiting
Other National Center for AIDS/STD Control and Prevention, China CDC trials
Trials by the same sponsor.
- NCT03852849 — Rapid Build of HIV Related Protective Barriers · NA · unknown
- NCT01764282 — Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06830668 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Center for AIDS/STD Control and Prevention, China CDC
- Last refreshed: 17 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06830668.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing