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

HIV Infections Clinical Trial

— MIND  

Official title:

Phase IV, Randomized, Multicenter and Double Clinical Trial Blind Designed 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: MIND Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05549180
• Other study ID #: GESIDA 11920
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: October 6, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2023
• Source: Fundacion SEIMC-GESIDA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The clinical trial is designed to compare people with HIV and neuropsychiatric vulnerabilities, the safety and tolerability of switch to BIC/FTC/TAF versus continue on DTG/3TC. The study includes the inclusion of 80 participants with HIV and who present among their personal history any of those established among the selection criteria (insomnia, anxiety or depression), agree to participate in the same The participants, after signing the informed consent and verifying the meeting of the selection criteria, they will be randomized to continue for 48 weeks with DTG/3TC + BIC/FTC/TAF placebo (arm 1) or switch to BIC/FTC/TAF + placebo DTG/3TC (arm 2). All participants, except those who discontinue the study early, must to complete the same schedule of visits. It will be cause of early discontinuation loss to follow-up, withdrawal of consent, or development of any condition that requires discontinuation or change of assigned treatment. During follow-up, the management of the basic neuropsychiatric pathology of each participant will be performed in accordance with normal clinical practice. In no case, the beginning, the change or the cessation of any pharmacological treatment or neuropsychiatric intervention should be affected by their participation in the study. If the situation arises where any participant developed a severe neuropsychiatric adverse effect (grade 3-4), two specialists in psychiatry experts in the management of patients with HIV would be responsible for evaluating them through the review of their medical history and an interview with the participant in person or via telematics. This evaluation will aim to confirm the relevance of the continuity of the patient in the study and the need for further preferential evaluation by psychiatry.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• BIKTARVY 50Mg-200Mg-25Mg Tablet and Dovato placebo
The patients randomized to experimental arm will be randomized to Biktarvy + Dovato placebo
• Dovato 50Mg-300Mg Tablet + Biktarvy placebo
The patients randomized to comparador arm will be randomized to Dovato + Biktarvy placebo

Locations

Country	Name	City	State
Spain	Hospital de Bellvitge	Barcelona
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	CHUAC	Coruña
Spain	Fundacion Hospital Alcorcón	Madrid
Spain	H. Universitario Infanta Leonor	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Puerta de Hierro	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	H. Costa del Sol	Marbella
Spain	H. Universitario Son Espases	Palma De Mallorca	Islas Baleares
Spain	Hospital Son Llatzer	Palma De Mallorca
Spain	H. Univ. Virgen Macarena	Sevilla
Spain	H. Clinico Univ. Lozano Blesa	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion SEIMC-GESIDA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory outcome: Brain integrity and functionality before and after switching to BIC/FTC/TAF.	Primary endpoint: Changes in brain volumes; Secondary endpoints: Changes in the levels of N-acetyl-aspartate, choline and myo-inositol at the frontal grey matter, frontal white matter, and basal ganglia; Changes in the integrity of the white matter; Changes in cerebral perfusion; Changes in brain resting state	48 weeks
Primary	The safety of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.	Primary endpoint: Proportion of neuropsychiatric adverse effects grade 2-4 (defined using the AIDS Clinical Trials Group Adverse Events Grading Score11); Secondary endpoints: Proportion of grade 2-4 adverse effects (defined using the AIDS Clinical Trials Group Adverse Events Grading Score11); Proportion of ART discontinuations due to neuropsychiatric adverse effects.; Proportion of ART discontinuations for any reason.	24-48 weeks
Secondary	The desirability of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.	Primary endpoint: Changes in sleep quality estimated using the Pittsburgh Sleep Quality Questionnaire (PSQI); Secondary endpoints: Changes in mood estimated using the hospital scale of anxiety and depression (HADS); Changes in the scale of satisfaction with ART (ESTAR); Changes in the Spanish version of the MOS HIV quality of life questionnaire.	24-48 weeks
Secondary	The efficacy of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.	Primary endpoint: Percentage of participants with HIV viral load >50 copies/mL, according to the Snapshot algorithm of the "US Food and Drug Administration" (margin to demonstrate non-inferiority: 4%); Secondary edpoints: 1)Proportion of participants with HIV viral load <50 copies/mL; 2) Proportion of participants with undetectable viral load.; 3) Proportion of patients with failure confirmed virology; 4) Percentage of patients with virological failure; 5) Proportion of participants experiencing blips during the study	24-48 weeks