Who is sponsoring NCT04155554?

NCT04155554 is sponsored by Azienda Ospedaliera Universitaria Senese.

What condition does NCT04155554 study?

NCT04155554 studies HIV-1-infection.

Is NCT04155554 still recruiting?

NCT04155554 is currently status unknown. Last updated 29 January 2020.

Last reviewed 2020-01-29 · How we verify

NCT04155554: DOBINeuro

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Effects of Switching From Dolutegravir/Lamivudine/Abacavir (d/l/a) to Bictegravir/Emtricitabine/Tenofovir Alafenamide (b/f/Taf) in Patients With Suppressed Viral Load on Neuropsychiatric Side Effects and Neurocognitive Function

Status unknown Phase 3 Last updated 29 January 2020

What this trial tests

Phase 3 trial testing Bictegravir/emtricitabine/tenofovir alafenamide in HIV-1-infection in 100 participants. Status unknown.

Timeline

29 January 2020

Primary endpoint
1 August 2020

1 July 2021

Quick facts

Lead sponsor	Azienda Ospedaliera Universitaria Senese
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	29 January 2020
Primary completion	1 August 2020
Estimated completion	1 July 2021
Sites	1 location across Italy

Drugs / interventions tested

Bictegravir/emtricitabine/tenofovir alafenamide — full drug profile →
Dolutegravir/lamivudine/abacavir — full drug profile →

Conditions studied

HIV-1-infection — all drugs for HIV-1-infection →

Sponsor

Azienda Ospedaliera Universitaria Senese — full company profile →

Who can join

18 and older, any sex, with HIV-1-infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

neuropsychiatric symptoms severity in 3 months
Time frame: 3 months
change in neuropsychiatric symptoms severity, using the Symptom Checklist-90-R, 3 months after switching to bictegravir or continuing dolutegravir (on treatment analysis).

Sponsor's own description

Prospective, randomized study (1: 1), open-label, controlled, phase 3, multicenter, non-profit. The hypothesis of the present study is that bictegravir is associated with a lower incidence and severity of neuropsychiatric symptoms than dolutegravir.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Evolution of Self-reported Neuropsychiatric Symptoms After Switching from Dolutegravir/Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Results from the Randomized DOBINeuro Trial.
Rossetti B, Ferrara M, Taramasso L, Bai F, et al · · 2025 · PMID 39612159 · DOI 10.1007/s40121-024-01083-1

Verify or expand the search:

Other trials of Bictegravir/emtricitabine/tenofovir alafenamide

Trials testing the same drug.

NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · Phase 1 · not yet recruiting
NCT06613685 — Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated · Phase 2, PHASE3 · terminated
NCT05526118 — Advanced HIV: Outcomes for Rapid ART · unknown
NCT03998176 — Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE · Phase 4 · completed
NCT04132674 — Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Mar · Phase 4 · unknown

Other recruiting trials for HIV-1-infection

Currently open trials in the same condition.

NCT07293559 — Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States · recruiting
NCT06919016 — A Study to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA Followed by DV701B1.1- · Phase 1 · active not recruiting
NCT06554717 — Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV · Phase 2 · recruiting
NCT06774872 — Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Succes · Phase 2 · recruiting
NCT06890988 — Ending the Epidemic Interventions in the Dental Setting - UH3 · NA · recruiting

Other Azienda Ospedaliera Universitaria Senese trials

Trials by the same sponsor.

NCT06520137 — Third Molars Extraction and Periodontal Disease · recruiting
NCT05701293 — A ProspeCtive mUlticenteR Investigation on RENzar Stent Safety and Efficacy in the Treatment of Patients With Femoro-pop · recruiting
NCT05420805 — Protective Role of Pre-/ Post-biotics on Gut Inflammation, Dysbiosis, and Life Quality in Rett Syndrome (Biotics_RTT) · NA · completed
NCT03992170 — Study of Daratumumab in Multiple Myeloma (MM) Patients in >VGPR/MRD-positive · Phase 2 · unknown
NCT03498664 — EMR-C VS EMR-S in Colonic Lateral Spreading Tumors Treatment (LST) · NA · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04155554 (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 Azienda Ospedaliera Universitaria Senese
Last refreshed: 29 January 2020

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/NCT04155554.

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