CTIS2024-511951-16-00Active, not recruitingPhase 1
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 - GESIDA 11920
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Fundacion Seimc Gesida
- Enrollment
- 84
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
- Sex
- All
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
Investigators
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