Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
84
Countries
1
Sites
13
HIV
The safety of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.
Key facts
- Sponsor
- Fundacion Seimc Gesida
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 30 Aug 2022 → 7 Aug 2024
- Decision date (initial)
- 2024-05-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Research grant of GILEAD SCIENCES S.A
External identifiers
- EU CT number
- 2024-511951-16-00
- EudraCT number
- 2021-005927-19
- ClinicalTrials.gov
- NCT05549180
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
The safety of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.
Secondary objectives 3
- The desirability of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.
- The efficacy of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.
- Exploratory outcome: Brain integrity and functionality before and after switching to BIC/FTC/TAF.
Conditions and MedDRA coding
HIV
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2021-005927-19 | Phase IV, randomized, multicenter, double-blind clinical trial designed to evaluate the safety and convenience of switching from Dolutegravir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir alafenamide in people with HIV, good virological control and neuropsychiatric vulnerabilities: MIND study, Ensayo clínico fase IV, aleatorizado, multicéntrico y doble ciego diseñado para evaluar la seguridad y la conveniencia del cambio de Dolutegravir/Lamivudina por Bictegravir/Emtricitabina/Tenofovir alafenamida en personas con VIH, buen control virológico y vulnerabilidades neuropsiquiátricas: Estudio MIND |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 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 6
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportion of neuropsychiatric adverse effects grade 2-4 (defined using the AIDS Clinical Trials Group Adverse Events Grading Score11)
Secondary endpoints 3
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 8
Biktarvy 50 mg/200 mg/25 mg film-coated tablets
PRD6357588 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 300 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AR20 — -
- Marketing authorisation
- EU/1/18/1289/001
- MA holder
- GILEAD SCIENCES IRELAND UNLIMITED COMPANY
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Biktarvy 50 mg/200 mg/25 mg film-coated tablets
PRD6357589 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 300 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR20 — -
- Marketing authorisation
- EU/1/18/1289/001
- MA holder
- GILEAD SCIENCES IRELAND UNLIMITED COMPANY
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Biktarvy 50 mg/200 mg/25 mg film-coated tablets
PRD6357590 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 300 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR20 — -
- Marketing authorisation
- EU/1/18/1289/001
- MA holder
- GILEAD SCIENCES IRELAND UNLIMITED COMPANY
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Biktarvy 50 mg/200 mg/25 mg film-coated tablets
PRD6357591 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 300 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR20 — -
- Marketing authorisation
- EU/1/18/1289/001
- MA holder
- GILEAD SCIENCES IRELAND UNLIMITED COMPANY
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Biktarvy 50 mg/200 mg/25 mg film-coated tablets
PRD9200497 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 300 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR20 — -
- Marketing authorisation
- EU/1/18/1289/003
- MA holder
- GILEAD SCIENCES IRELAND UNLIMITED COMPANY
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Biktarvy 50 mg/200 mg/25 mg film-coated tablets
PRD9200500 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 300 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR20 — -
- Marketing authorisation
- EU/1/18/1289/003
- MA holder
- GILEAD SCIENCES IRELAND UNLIMITED COMPANY
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Biktarvy 50 mg/200 mg/25 mg film-coated tablets
PRD9200501 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 300 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR20 — -
- Marketing authorisation
- EU/1/18/1289/003
- MA holder
- GILEAD SCIENCES IRELAND UNLIMITED COMPANY
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Biktarvy 50 mg/200 mg/25 mg film-coated tablets
PRD9200503 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 300 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR20 — -
- Marketing authorisation
- EU/1/18/1289/003
- MA holder
- GILEAD SCIENCES IRELAND UNLIMITED COMPANY
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 4
Dovato 50 mg/300 mg film-coated tablets
PRD7413972 · Product
- Active substance
- Lamivudine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 300 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR25 — -
- Marketing authorisation
- EU/1/19/1370/001
- MA holder
- VIIV HEALTHCARE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dovato 50 mg/300 mg film-coated tablets
PRD7414367 · Product
- Active substance
- Lamivudine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 300 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR25 — -
- Marketing authorisation
- EU/1/19/1370/001
- MA holder
- VIIV HEALTHCARE B.V.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dovato 50 mg/300 mg film-coated tablets
PRD7414368 · Product
- Active substance
- Lamivudine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 300 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR25 — -
- Marketing authorisation
- EU/1/19/1370/001
- MA holder
- VIIV HEALTHCARE B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dovato 50 mg/300 mg film-coated tablets
PRD7414369 · Product
- Active substance
- Lamivudine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 300 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR25 — -
- Marketing authorisation
- EU/1/19/1370/001
- MA holder
- VIIV HEALTHCARE B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Seimc Gesida
- Sponsor organisation
- Fundacion Seimc Gesida
- Address
- Calle De Agustin De Betancourt 13 Entreplanta
- City
- Madrid
- Postcode
- 28003
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Seimc Gesida
- Contact name
- Investigación clínica
Public contact point
- Organisation
- Fundacion Seimc Gesida
- Contact name
- Secretaría FSG
Sponsor responsibilities
- Article 77 compliance
- Fundacion Seimc Gesida
- Contact point sponsor
- Fundacion Seimc Gesida
- Article 77 implementation
- Fundacion Seimc Gesida
Locations
1 EU/EEA country · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 84 | 13 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Costa Del Sol
Internal Medicine, Terreno Autovia Mediterraneo A-7 S/n, 29603, Marbella
Hospital Universitario Puerta De Hierro De Majadahonda
Internal Medicine, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Clinico San Carlos
Internal Medicine, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Universitario Infanta Leonor
Infectious Diseases, Avenida Gran Via Del Este 80, 28031, Madrid
Hospital Universitario La Paz
Internal Medicine, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario Virgen De La Macarena
Infectious Diseases, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital General Universitario Reina Sofia
Infectious Diseases, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Clinico Universitario Lozano Blesa
Infectious Diseases, Avenida De San Juan Bosco 15, 50009, Zaragoza
Complexo Hospitalario Universitario A Coruna
Infectious Diseases, Lugar Jubias De Arriba 84, 15006, A Coruna
Bellvitge University Hospital
Infectious Diseases, Carrer De La Feixa Llarga S/n, 08907, L'hospitalet De Llobregat
Hospital Universitario Fundacion Alcorcon
Internal Medicine, Calle Budapest 1, 28922, Alcorcon
Hospital Son Llatzer
Internal Medicine, Carretera De Manacor Km 4, 07198, Palma
University Hospital Son Espases
Infectious Diseases, Carretera Valldemossa 79, 07120, Palma
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2022-08-30 | 2024-08-07 | 2022-09-27 | 2023-08-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Final report of PASO-DOBLE study SUM-133983
|
2026-05-13T16:51:00 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Final Lay person summary of PASO-DOBLE study | 2026-05-13T16:51:56 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | GESIDA11920_Lay Person Summary of Results_Final | 1 |
| Summary of results (for publication) | GESIDA11920_Summary of Results_Final | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-17 | Spain | Acceptable 2024-05-13
|
2024-05-13 |