EUCTR2016-004646-29-ES
Active, not recruiting
Phase 1
A phase IV open- label, randomized and pilot clinical trial, designed to evaluate the potential neurotoxicity of dolutegravir/lamivudine/abacavir in neurosymptomatic HIV patients and their reversibility after switching to elvitegravir/cobicistat/emtricitabina/tenofovir alafenamide - DREAM
Fundación SEIMC-GESIDA0 sites64 target enrollmentApril 21, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fundación SEIMC-GESIDA
- Enrollment
- 64
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient \> 18 years of age diagnosed with HIV using normal serology techniques.
- •Current antiretroviral therapy with DTG/3TC/ABC.
- •HIV viral load \< 50 copies/mL for at least 12 weeks prior to signing the consent form \[(]confirmed by two assays at least 12 weeks apart with viremia \< 50 copies/mL between both
- •Appearance or worsening of the following symptoms compared to when DTG/3TC/ABC was started:
- •\- Symptoms of anxiety or depression
- •\- Insomnia or other sleep disturbances
- •\- Headache
- •\- Cognitive complaints (attention, concentration or memory)
- •\- Alterations in behaviour (irritability, aggressiveness or agitation)
- •\- Dizziness of neurological or neurologically\-mediated origin
Exclusion Criteria
- •Determination of at least one HIV viral load \= 50 copies/mL in the last 12 weeks.
- •Allergy, intolerance or existence of resistance mutations to any of the components of ELV/COBI/FTC/TAF
- •History of active CNS infections
- •Active psychosis, major depression with psychotic symptoms or autolytic ideation
- •Dementia or mental retardation
- •Drug use with a diagnosis of abuse or dependence according to DSM\-5 criteria
- •Illnesses that may interfere with the study procedures
- •Claustrophobia
- •Presence of magnetisable devices in the body
- •Inability to complete any of the study procedures
Outcomes
Primary Outcomes
Not specified
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