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)

Fundacion SEIMC-GESIDA

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet and Dovato placebo; Drug: Dovato 50Mg-300Mg Tablet + Biktarvy placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05549180

GESIDA 11920

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

84 participants in 2 patient groups

Patients received DTG/3TC + BIC/FTC/TAF placebo

Active Comparator group

Description:

DTG 50 mg/3TC 300 mg 1 tablet per day + BIC 50 mg/ FTC 200 mg/ TAF 25 mg placebo 1 tablet per day

Treatment:

Drug: Dovato 50Mg-300Mg Tablet + Biktarvy placebo

Patients received BIC/FTC/TAF + DTG/3TC placebo

Experimental group

Description:

BIC 50 mg/ FTC 200 mg/ TAF 25 mg per day + DTG 50 mg/3TC 300 mg placebo1 tablet per day

Treatment:

Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet and Dovato placebo