Phase IV, Randomized, Multicenter, Double-Blind Clinical Trial Designed to Evaluate the Safety and Appropriateness of Switching from DTG/3TC to BIC/FTC/TAF in People With HIV, Good Virological Control, and Neuropsychiatric Vulnerabilities: MIND Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511951-16-00

Acronym

GESIDA 11920

Enrollment

Registered

2024-05-13

Start date

2022-08-30

Completion date

2024-08-07

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Brief summary

Proportion of neuropsychiatric adverse effects grade 2-4 (defined using the AIDS Clinical Trials Group Adverse Events Grading Score11)

Detailed description

Proportion of grade 2-4 adverse effects (defined using the AIDS Clinical Trials Group Adverse Events Grading Score11), Proportion of ART discontinuations due to neuropsychiatric adverse effects., Proportion of ART discontinuations for any reason.

Interventions

DRUGBiktarvy 50 mg/200 mg/25 mg film-coated tablets

DRUGDovato 50 mg/300 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Proportion of neuropsychiatric adverse effects grade 2-4 (defined using the AIDS Clinical Trials Group Adverse Events Grading Score11)	—

Secondary

Measure	Time frame
Proportion of grade 2-4 adverse effects (defined using the AIDS Clinical Trials Group Adverse Events Grading Score11), Proportion of ART discontinuations due to neuropsychiatric adverse effects., Proportion of ART discontinuations for any reason.	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026