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
- Conditions
- Human immunodeficiency virusMedDRA version: 20.0Level: PTClassification code 10053500Term: Human immunodeficiency virus transmissionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2021-005927-19-ES
- Lead Sponsor
- Fundación SEIMC-GESIDA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 80
• 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 < 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 the screening visit that the participant's HIV viral load is <50 cop/mL .
• Previous clinical diagnosis of any of the following pathologies:
or insomnia
or anxiety disorders
or depressive disorders
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>- Proportion of grade 2-4 adverse effects.<br>- Proportion of antiretroviral treatment discontinuations due to neuropsychiatric adverse effects.<br>- 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 Outcome Measures
Name Time Method Secondary end point(s): - Changes in sleep quality estimated using the Pittsburgh Sleep Quality Questionnaire (PSQI).<br>- Changes in mood estimated using the Hospital Anxiety and Depression Scale (HADS).<br>- Changes in the scale of satisfaction with ART (ESTAR).<br>- 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.