Clinical trial NCT03067285: A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study
Official title: A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Fundacion SEIMC-GESIDA
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A phase IV, open-label, randomised, pilot clinical trial
Primary purpose: TREATMENT

Brief summary: A phase IV, multicentre, randomised, open-label, pilot clinical trial designed to evaluate HIV-infected, aviremic patients who receive treatment with the combination of DTG/3TC/ABC and who have neuropsychiatric adverse effects that, in the opinion of the investigators, may be related to taking DTG/3TC/ABC, if they improve after switching antiretroviral therapy to the combination of ELV/COBI/FTC/TAF.

Detailed description: we estimate that 64 participants will need to be enrolled in the study to demonstrate symptomatic improvement after switching antiretroviral therapy from DTG/3TC/ABC to ELV/COBI/FTC/TAF.

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). If the patient has a recent routine blood test available (≤ 4 weeks) that includes determining HIV viral load, these results may be used for the screening visit. If this test is not available, or the test is more than four weeks old, viral load will be determined on the day of screening in order to confirm that the patient meets this criterion.
* 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
* Pregnant or nursing women, as well as women of childbearing age who do not agree to use an adequate birth control method.

Primary outcomes:
measure: To compare changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC, perceived by patients randomised to begin isolated symptomatic treatment or treatment associated with switching antiretroviral therapy.
timeFrame: Week 4
measure: To compare changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC, perceived by patients randomised to begin isolated symptomatic treatment or treatment associated with switching antiretroviral therapy.
timeFrame: Week 4
measure: To compare changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC, perceived by patients randomised to begin isolated symptomatic treatment or treatment associated with switching antiretroviral therapy.
timeFrame: Week 4
Secondary outcomes:
measure: To evaluate changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC after switching to ELV/COBI/FTC/TAF
timeFrame: Week 4
measure: To evaluate changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC after switching to ELV/COBI/FTC/TAF
timeFrame: Week 4
measure: To evaluate changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC after switching to ELV/COBI/FTC/TAF
timeFrame: Week 4
measure: To evaluate changes in neurocognitive function and volumetric, spectroscopic, tractographic and cerebral perfusion markers, acquired by Magnetic Resonance Imaging, after switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF
timeFrame: Week 24 after the switching
measure: To evaluate changes in neurocognitive function and volumetric, spectroscopic, tractographic and cerebral perfusion markers, acquired by Magnetic Resonance Imaging, after switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF
timeFrame: Week 24 after the switching
measure: To evaluate changes in neurocognitive function and volumetric, spectroscopic, tractographic and cerebral perfusion markers, acquired by Magnetic Resonance Imaging, after switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF
timeFrame: Week 24 after the switching
measure: Percentages of virologic failure
timeFrame: Week 24 after the switching
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
state: Madrid
city: Madrid
country: Spain
facility: Hospital Fundación Jimenez Díaz
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Univ. Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Univ. La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References: