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NCT05549180CompletedPhase 4

Clinical Trial to Evaluate the Safety and Appropriateness of Switching from Dolutegravir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in People With HIV, Good Control and Neuropsychiatric Vulnerabilities: MIND Study

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 May 2024

Brief summary (registry, in English)

The safety of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
84 (actual)
First submitted
17 Apr 2024
Start date
30 Aug 2022
Lead sponsor
Fundacion Seimc Gesida
Diseases
HIV
NCT number
NCT05549180
EU CT number
2024-511951-16-00
EudraCT number
2021-005927-19

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 84
  • 13 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Allergy or intolerance to any of the components of BIC/FTC/TAF
  • History of active CNS infections

Lab values

  • Any clinical or laboratory condition that in the opinion of the investigator will prevent the participant to complete the study procedures

Age

  • Pregnant or lactating women, as well as women of childbearing age who do not commit to use at least two contraceptive methods

Other

  • Active psychosis or suicidal ideation
  • Participant included in the neuroimaging substudy: Claustrophobia or presence of magnetizable body devices

Who the study is looking for

  • Adult >18 years diagnosed with HIV by standard microbiological techniques
  • Active antiretroviral treatment with DTG/3TC
  • Last HIV viral load performed on the participant in the 6 months prior to the visit screening < 50 copies/mL. If the participant does not have an HIV viral load <50 cop/mL performed in the 14 days prior to the screening visit, it will be necessary to confirm at screening visit that the participant's HIV viral load is <50 cop/mL
  • Prior clinical diagnosis, carried out by a qualified specialist physician, of any of the following pathologies: Insomnia Anxiety disorders Depressive disorders

Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Complexo Hospitalario Universitario A Coruña
Coordinator of this site? Confirm its status
A CoruñaSpainCompleted
Hospital Universitario Fundación Alcorcón
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AlcorcónSpainCompleted
Hospital General Universitario Reina Sofia
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CórdobaSpainCompleted
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainCompleted
Hospital Universitario Infanta Leonor
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MadridSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Hospital Clínico San Carlos
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MadridSpainCompleted
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainCompleted
Hospital Costa del Sol
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MarbellaSpainCompleted
Hospital Son Llatzer
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PalmaSpainCompleted
University Hospital Son Espases
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PalmaSpainCompleted
Hospital Universitario Virgen De La Macarena
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SevillaSpainCompleted
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainCompleted

This page is information, not medical advice. Discuss any trial with your doctor.