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

NCT05549180 | Completed Phase 4

• 1 other identifier: GESIDA 11920
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 14

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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: 1. Proportion of grade 2-4 adverse effects (defined using the AIDS Clinical Trials Group Adverse Events Grading Score11) 2. Proportion of ART discontinuations due to neuropsychiatric adverse effects. 3. Proportion of ART discontinuations for any reason.

  24-48 weeks

Secondary Outcomes (2)

• The desirability of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.

  24-48 weeks

• The efficacy of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.

  24-48 weeks

Other Outcomes (1)

• Exploratory outcome: Brain integrity and functionality before and after switching to BIC/FTC/TAF.

  48 weeks

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

EXPERIMENTAL

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

Interventions

BIKTARVY 50Mg-200Mg-25Mg Tablet and Dovato placebo DRUG

The patients randomized to experimental arm will be randomized to Biktarvy + Dovato placebo

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

Dovato 50Mg-300Mg Tablet + Biktarvy placebo DRUG

The patients randomized to comparador arm will be randomized to Dovato + Biktarvy placebo

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion SEIMC-GESIDA: lead

Study Sites (14)

H. Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

Location

CHUAC

A Coruña, Spain

Location

Hospital de Bellvitge

Barcelona, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Spain

Location

Fundacion Hospital Alcorcón

Madrid, Spain

Location

H. Universitario Infanta Leonor

Madrid, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital Puerta de Hierro

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario La Princesa

Madrid, Spain

Location

H. Costa del Sol

Marbella, Spain

Location

Hospital Son Llatzer

Palma de Mallorca, Spain

Location

H. Univ. Virgen Macarena

Seville, Spain

Location

H. Clinico Univ. Lozano Blesa

Zaragoza, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The clinical trial is double blind. The only people who will know the arm that patient has been randomized, the participant will be responsible for the pharmacy in charge of dispensing treatment and a "non-blind" person designated by the promoter. The masking of study will only be open upon completion of the study or in the event that a participant developes a serious adverse event that requires knowing the treatment the patient is receiving participant for clinical management. If it is necessary a open blind premature manually, the investigator should contact the "non-blind" person designated by the the promoter by calling a phone number and indicating that they wish to break prematurely blinded a patient in the MIND study. After confirming that it is required to opening of the blind (because the condition described above occurs), the person "not blind" designated by the sponsor will indicate to the investigator the treatment arm that was receiving the patient
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: September 22, 2022
• Study Start: October 6, 2022
• Primary Completion: February 13, 2024
• Study Completion: August 7, 2024
• Last Updated: July 18, 2025

Record last verified: 2024-06

Locations

ES (14)