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NCT07004933: BFTAFDU
Rapid Antiretroviral Treatment Initiation With BIC/FTC/TAF in HIV-infected People Who Inject Drugs (PWID)
trial testing bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) in HIV Positive People Who Inject Drugs in 37 participants. Completed in 9 December 2024.
9 December 2024
Quick facts
| Lead sponsor | Hellenic Scientific Society for the Study of AIDS, Sexually Transmitted and Emerging Diseases |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 37 |
| Start date | 22 December 2021 |
| Primary completion | 9 December 2024 |
| Estimated completion | 9 December 2024 |
| Sites | 3 locations across Greece |
Drugs / interventions tested
- bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) — full drug profile →
Conditions studied
- HIV Positive People Who Inject Drugs — all drugs for HIV Positive People Who Inject Drugs →
Sponsor
Hellenic Scientific Society for the Study of AIDS, Sexually Transmitted and Emerging Diseases
Who can join
18 and older, any sex, with HIV Positive People Who Inject Drugs. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical study is to evaluate the effectiveness, safety and patient experience of an integrated care pathway combining rapid antiretroviral (ART) initiation with BIC/FTC/TAF and peer navigation for treatment naïve newly-diagnosed or relinking HIV-infected PWIDs, in terms of viral suppression rates, adverse events and patient-reported health outcomes (PROs). The main objectives of the study are the assessment of: * The viral suppression rates at 24 weeks after the rapid initiation of ART with BIC/FTC/TAF coupled with secured peer-navigation in adult HIV-positive PWID who are treatment-naïve or re-linking to care * The safety and tolerability of BIC/FTC/TAF in the specific context of rapid ART initiation in adult PWID who are treatment-naïve or re-linking to care from baseline until Week 24. Patients will receive their medication according to the standard of care and will visit the clinic as usual. No extra visits or extra lab tests will be performed.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Rapid ART Initiation with BIC/FTC/TAF in People Who Inject Drugs in Greece: Results from a Pilot Single-Arm Study of an Integrated Care Model.
Roussos S, Protopapas K, Mastrogianni E, Totsikas C, et al · · 2025 · PMID 41471901 · DOI 10.3390/microorganisms13122697
Verify or expand the search:
- PubMed search for NCT07004933
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)
Trials testing the same drug.
- NCT04249037 — Rapid Start vs. Standard Start Antiretroviral Therapy (ART) in HIV · Phase 4 · terminated
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 NCT07004933 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hellenic Scientific Society for the Study of AIDS, Sexually Transmitted and Emerging Diseases
- Last refreshed: 4 June 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/NCT07004933.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing