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 1

• Conditions: HIV; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: CTIS2024-511951-16-00
• Lead Sponsor: Fundacion Seimc Gesida

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-17
• Study Completion: 2024-08-07
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

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

Exclusion Criteria

Allergy or intolerance to any of the components of BIC/FTC/TAF, History of active CNS infections, Active psychosis or suicidal ideation, Pregnant or lactating women, as well as women of childbearing age who do not commit to use at least two contraceptive methods, Any clinical or laboratory condition that in the opinion of the investigator will prevent the participant to complete 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: The safety of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.;Secondary Objective: The desirability of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC., The efficacy of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC., Exploratory outcome: Brain integrity and functionality before and after switching to BIC/FTC/TAF.;Primary end point(s): Proportion of neuropsychiatric adverse effects grade 2-4 (defined using the AIDS Clinical Trials Group Adverse Events Grading Score11)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Proportion of grade 2-4 adverse effects (defined using the AIDS Clinical Trials Group Adverse Events Grading Score11);Secondary end point(s):Proportion of ART discontinuations due to neuropsychiatric adverse effects.;Secondary end point(s):Proportion of ART discontinuations for any reason.