Clinical trial NCT05549180: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Fundacion SEIMC-GESIDA
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The drugs used will be drugs for commercial use that contain the active ingredients uses in this study:

* Experimental regimen:

  * Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir alafenamide 25mg (combined in a single tablet marketed under the name of Biktarvy®). This regimen is given as 1 tablet once a day.
  * Placebo dolutegravir 50mg/ lamivudine 300mg (combined in a single tablet marketed under the name Dovato®). This regimen istake as 1 tablet once a day.
* Control regimen:

  * Dolutegravir 50mg/ lamivudine 300mg (combined in a single tablet marketed under the name Dovato®). This regimen is administered as 1 tablet once a day.
  * Placebo bictegravir 50mg/ emtricitabine 200mg/ tenofovir alafenamide 25mg (combined in a single tablet marketed under the name of Biktarvy®). This regimen is given as 1 tablet once a day.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: The safety of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.
timeFrame: 24-48 weeks
Secondary outcomes:
measure: The desirability of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.
timeFrame: 24-48 weeks
measure: The efficacy of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.
timeFrame: 24-48 weeks
Other outcomes:
measure: Exploratory outcome: Brain integrity and functionality before and after switching to BIC/FTC/TAF.
timeFrame: 48 weeks
Locations:
city: Palma De Mallorca
country: Spain
facility: H. Universitario Son Espases
state: Islas Baleares
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
city: Coruña
country: Spain
facility: CHUAC
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Madrid
country: Spain
facility: Fundacion Hospital Alcorcón
city: Madrid
country: Spain
facility: H. Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Marbella
country: Spain
facility: H. Costa del Sol
city: Palma De Mallorca
country: Spain
facility: Hospital Son Llatzer
city: Sevilla
country: Spain
facility: H. Univ. Virgen Macarena
city: Zaragoza
country: Spain
facility: H. Clinico Univ. Lozano Blesa
Study officials:
References: