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 (MIND)

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Dovato 50Mg-300Mg Tablet + Biktarvy placebo; Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet and Dovato placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital De Bellvitge
  • Coruña, Spain
    • CHUAC
  • Córdoba, Spain
    • Hospital Universitario Reina Sofia
  • Madrid, Spain
    • Hospital Clinico San Carlos
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Hospital Puerta de Hierro
  • Madrid, Spain
    • Hospital Universitario La Princesa
  • Madrid, Spain
    • Fundacion Hospital Alcorcon
  • Madrid, Spain
    • H. Universitario Infanta Leonor
  • Marbella, Spain
    • H. Costa del Sol
  • Palma De Mallorca, Spain
    • Hospital Son Llàtzer
  • Sevilla, Spain
    • H. Univ. Virgen Macarena
  • Zaragoza, Spain
    • H. Clinico Univ. Lozano Blesa
  • Islas Baleares
    • Palma De Mallorca, Islas Baleares, Spain
      • H. Universitario Son Espases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients received DTG/3TC + BIC/FTC/TAF placebo; DTG 50 mg/3TC 300 mg 1 tablet per day + BIC 50 mg/ FTC 200 mg/ TAF 25 mg placebo 1 tablet per day	Drug: Dovato 50Mg-300Mg Tablet + Biktarvy placebo; The patients randomized to comparador arm will be randomized to Dovato + Biktarvy placebo
Experimental: Patients received BIC/FTC/TAF + DTG/3TC placebo; BIC 50 mg/ FTC 200 mg/ TAF 25 mg per day + DTG 50 mg/3TC 300 mg placebo1 tablet per day	Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet and Dovato placebo; The patients randomized to experimental arm will be randomized to Biktarvy + Dovato placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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/mL2) Proportion of participants with undetectable viral load.3) Proportion of patients with failure confirmed virology4) Percentage of patients with virological failure5) Proportion of participants experiencing blips during the study	24-48 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fundacion SEIMC-GESIDA

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2022
• Primary Completion (Actual): February 13, 2024
• Study Completion (Actual): August 7, 2024

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Nucleic Acid Synthesis Inhibitors; Antiviral Agents; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Emtricitabine
• Other Study ID Numbers: GESIDA 11920

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No