HIV InfectionsPhase 4MINDNCT05549180
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
A Phase 4 study of HIV Infections, run by Fundacion SEIMC-GESIDA at 14 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 14 sitesSpain
- Study dates
- 6 Oct 2022to 7 Aug 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
CHUAC
A Coruña
Hospital de Bellvitge
Barcelona
Hospital Universitario Reina Sofía
Córdoba
Fundacion Hospital Alcorcón
Madrid
H. Universitario Infanta Leonor
Madrid
Hospital Clínico San Carlos
Madrid
Hospital Puerta de Hierro
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario La Princesa
Madrid
H. Costa del Sol
Marbella
H. Universitario Son Espases
Palma de Mallorca, Balearic Islands
Hospital Son Llatzer
Palma de Mallorca
H. Univ. Virgen Macarena
Seville
H. Clinico Univ. Lozano Blesa
Zaragoza
About this study
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
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- BIKTARVY 50Mg-200Mg-25Mg Tablet and Dovato placebo, Dovato 50Mg-300Mg Tablet + Biktarvy placebo
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIKTARVY 50Mg-200Mg-25Mg Tablet and Dovato placeboDrug
The patients randomized to experimental arm will be randomized to Biktarvy + Dovato placebo
Dovato 50Mg-300Mg Tablet + Biktarvy placeboDrug
The patients randomized to comparador arm will be randomized to Dovato + Biktarvy placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet and Dovato placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24-48 weeks
Secondary outcomes (2)
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.
Measured: 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/mL
- Proportion of participants with undetectable viral load.
- Proportion of patients with failure confirmed virology
- Percentage of patients with virological failure
- Proportion of participants experiencing blips during the study
Measured: 24-48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start6 Oct 2022
- Primary completion13 Feb 2024
- Study completion7 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549180
- Sponsor's protocol ID
- GESIDA 11920
- Acronym
- MIND
- Status last verified
- Jun 2024
- First submitted
- 1 Jun 2022
- Last updated
- 18 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05549180
- Acronym / sponsor ID
- MIND / GESIDA 11920
- Conditions
- HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Fundacion SEIMC-GESIDAUniversity, hospital or other
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 7 Aug 2024 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients received DTG/3TC + BIC/FTC/TAF placebo | Active comparator | Drug: Dovato 50Mg-300Mg Tablet + Biktarvy placeboDTG 50 mg/3TC 300 mg 1 tablet per day + BIC 50 mg/ FTC 200 mg/ TAF 25 mg placebo 1 tablet per day |
| Patients received BIC/FTC/TAF + DTG/3TC placebo | Experimental | Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet and Dovato placeboBIC 50 mg/ FTC 200 mg/ TAF 25 mg per day + DTG 50 mg/3TC 300 mg placebo1 tablet per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIKTARVY 50Mg-200Mg-25Mg Tablet and Dovato placeboThe patients randomized to experimental arm will be randomized to Biktarvy + Dovato placebo | Drug | Patients received BIC/FTC/TAF + DTG/3TC placebo |
| Dovato 50Mg-300Mg Tablet + Biktarvy placeboThe patients randomized to comparador arm will be randomized to Dovato + Biktarvy placebo | Drug | Patients received DTG/3TC + BIC/FTC/TAF placebo |
Primary outcome
The safety of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.
Time frame: 24-48 weeks
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.
2 secondary outcomes
The desirability of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.
Time frame: 24-48 weeks
The efficacy of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.
Time frame: 24-48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of HIV Infections, run by Fundacion SEIMC-GESIDA at 14 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC. (time frame: 24-48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.