Phase IV, Randomized, Multicenter and Double Clinical Trial Blind to Assess Safety and Convenience of the Change From DTG/3TC to BIC/FTC/TAF in People With HIV, Good Virological Control and Neuropsychiatric Vulnerabilities

• Status: Not yet recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

In people infected with HIV, with suppressed HIV viral load and receiving treatment with DTG/3TC:

The change to BIC/FTC/TAF will decrease the development of adverse events of neuropsychiatric etiology.

The change to BIC/FTC/TAF may improve the patient´s tolerability and degree of acceptance and use of TAR.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion SEIMC-GESIDA
• Treatments: Emtricitabine

Criteria

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