DREAM study

Phase 1

• Conditions: HIV; MedDRA version: 19.1 Level: LLT Classification code 10001509 Term: AIDS System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-004646-29-ES
• Lead Sponsor: Fundación SEIMC-GESIDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-21
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 64

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 64
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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
•Pregnant or nursing women, as well as women of childbearing age who do not agree to use an adequate birth control method.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified