NCT05549180CompletedPhase 4
Clinical Trial to Evaluate the Safety and Appropriateness of Switching from Dolutegravir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in People With HIV, Good Control and Neuropsychiatric Vulnerabilities: MIND Study
Phase IV, Randomized, Multicenter, Double-Blind Clinical Trial Designed to Evaluate the Safety and Appropriateness of Switching from DTG/3TC to BIC/FTC/TAF in People With HIV, Good Virological Control, and Neuropsychiatric Vulnerabilities: MIND Study
Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 May 2024
Brief summary (registry, in English)
The safety of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 84 (actual)
- First submitted
- 17 Apr 2024
- Start date
- 30 Aug 2022
- Lead sponsor
- Fundacion Seimc Gesida
- Diseases
- HIV
- NCT number
- NCT05549180
- EU CT number
- 2024-511951-16-00
- EudraCT number
- 2021-005927-19
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 84
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Allergy or intolerance to any of the components of BIC/FTC/TAF
- History of active CNS infections
Lab values
- Any clinical or laboratory condition that in the opinion of the investigator will prevent the participant to complete the study procedures
Age
- Pregnant or lactating women, as well as women of childbearing age who do not commit to use at least two contraceptive methods
Other
- Active psychosis or suicidal ideation
- Participant included in the neuroimaging substudy: Claustrophobia or presence of magnetizable body devices
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Completed |
| Hospital Universitario Fundación Alcorcón Coordinator of this site? Confirm its status | Alcorcón | Spain | Completed |
| Hospital General Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Completed |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Completed |
| Hospital Universitario Infanta Leonor Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Completed |
| Hospital Costa del Sol Coordinator of this site? Confirm its status | Marbella | Spain | Completed |
| Hospital Son Llatzer Coordinator of this site? Confirm its status | Palma | Spain | Completed |
| University Hospital Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Completed |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.