Clinical trial designed to evaluate the safety and convenience 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 convenience of switching from Dolutegravir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir alafenamide in people with HIV, good virological control and neuropsychiatric vulnerabilities: MIND study - MIND

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005927-19-ES

Enrollment

Registered

2022-03-02

Start date

2022-05-17

Completion date

Unknown

Last updated

2022-05-23

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

Conditions

Human immunodeficiency virus MedDRA version: 20.0 Level: PT Classification code 10053500 Term: Human immunodeficiency virus transmission System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Biktarvy Product Name: Biktarvy Product Code: EU/1/18/1289/004 Pharmaceutical Form: Tablet INN or Proposed INN: Bictegravir CAS Number: SUB182699 Current Sponsor code: Gilead Other descrip

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Adult >18 years old diagnosed with HIV by standard microbiological techniques. • Active antiretroviral treatment with Dolutegravit/Lamivudine. • Last HIV viral load performed on the participant in the 6 months prior to the screening visit =65 years) yes F.1.3.1 Number of subjects for this age range 80

Exclusion criteria

Exclusion criteria: • Allergy or intolerance to any of the components of Bictegravir/Emtricitabine/Tenofovir alafenamide. • History of active central nervous system infections. • Active psychosis or suicidal ideation • Pregnant or lactating women, as well as women of childbearing age who do not agree to use at least two contraceptive methods. • Any clinical or laboratory condition that in the opinion of the investigator will prevent the participant from completing the study procedures. • Participant included in the neuroimaging substudy: Claustrophobia or presence of magnetizable body devices.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the safety of switching to Bictegravir/Emtricitabine/Tenofovir alafenamide versus continuing treatment with Dolutegravir/Lamivudine.;Secondary Objective: To compare the convenience of switching to Bictegravir/Emtricitabine/Tenofovir alafenamide versus continuing treatment with Dolutegravir/Lamivudine.;Primary end point(s): - Proportion of grade 2-4 neuropsychiatric adverse effects. - Proportion of grade 2-4 adverse effects. - Proportion of antiretroviral treatment discontinuations due to neuropsychiatric adverse effects. - Proportion of antiretroviral treatment discontinuations for any reason.;Timepoint(s) of evaluation of this end point: Endpoints will be continuously assessed during the clinical trial at Week 24 and Week 48 for grade 2-4 neuropsychiatric adverse events and grade 2-4 adverse events and reasons for antiretroviral treatment discontinuation.	—

Measure

Time frame

Main Objective: To compare the safety of switching to Bictegravir/Emtricitabine/Tenofovir alafenamide versus continuing treatment with Dolutegravir/Lamivudine.;Secondary Objective: To compare the convenience of switching to Bictegravir/Emtricitabine/Tenofovir alafenamide versus continuing treatment with Dolutegravir/Lamivudine.;Primary end point(s): - Proportion of grade 2-4 neuropsychiatric adverse effects. - Proportion of grade 2-4 adverse effects. - Proportion of antiretroviral treatment discontinuations due to neuropsychiatric adverse effects. - Proportion of antiretroviral treatment discontinuations for any reason.;Timepoint(s) of evaluation of this end point: Endpoints will be continuously assessed during the clinical trial at Week 24 and Week 48 for grade 2-4 neuropsychiatric adverse events and grade 2-4 adverse events and reasons for antiretroviral treatment discontinuation.

—

Secondary

Measure	Time frame
Secondary end point(s): - Changes in sleep quality estimated using the Pittsburgh Sleep Quality Questionnaire (PSQI). - Changes in mood estimated using the Hospital Anxiety and Depression Scale (HADS). - Changes in the scale of satisfaction with ART (ESTAR). - Changes in the Spanish version of the MOS-HIV quality of life questionnaire.;Timepoint(s) of evaluation of this end point: The variables will be continuously evaluated during the clinical trial at Week 24 and Week 48 by evaluating the Pittsburgh Sleep Quality Questionnaire, the Hospital Anxiety and Depression Scale, the STAR Scale, and the MOS-HIV Quality of Life Questionnaire.	—

Measure

Time frame

Secondary end point(s): - Changes in sleep quality estimated using the Pittsburgh Sleep Quality Questionnaire (PSQI). - Changes in mood estimated using the Hospital Anxiety and Depression Scale (HADS). - Changes in the scale of satisfaction with ART (ESTAR). - Changes in the Spanish version of the MOS-HIV quality of life questionnaire.;Timepoint(s) of evaluation of this end point: The variables will be continuously evaluated during the clinical trial at Week 24 and Week 48 by evaluating the Pittsburgh Sleep Quality Questionnaire, the Hospital Anxiety and Depression Scale, the STAR Scale, and the MOS-HIV Quality of Life Questionnaire.

—

Countries

Spain

Contacts

Public ContactMiriam Pérez Marcos

Dynamic Science S.L.

m.perez@evidenze.com0034914561105

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026