Phase IV, a Clinical Trial to Assess Safety and Convenience of the Change From DTG/3TC to BIC/FTC… (NCT05549180) | Clinical Trial Compass
CompletedPhase 4
Phase IV, a Clinical Trial 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
Spain84 participantsStarted 2022-10-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
The safety of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.