Clinical Trials

MainTitle

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 (DREAM)

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified February 2017 by Fundacion SEIMC-GESIDA

Sponsor
Fundacion SEIMC-GESIDA


Information provided by (Responsible Party)
Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier
NCT03067285

First received: February 14, 2017
Last updated: July 31, 2017
Last Verified: February 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : ELV/COBI/FTC/TAF
Drug : DTG/3TC/ABC + ELV/COBI/FTC/TAF
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A phase IV, open-label, randomised, pilot clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Fundacion SEIMC-GESIDA:

Primary Outcome Measures

  • 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. [ Time Frame: Week 4 ]
    To compare, between the two arms of the study, changes in the percentage and in the severity of neuropsychiatric symptoms compiled using the ACTG adverse effects scale. anxiety and depression scale.
  • 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. [ Time Frame: Week 4 ]
    To compare, between the two arms of the study, changes in the percentage and in the severity of neuropsychiatric symptoms compiled using the pittsburgh sleep quality index.
  • 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. [ Time Frame: Week 4 ]
    To compare, between the two arms of the study, changes in the percentage and in the severity of neuropsychiatric symptoms compiled using the depression scale.
Secondary Outcome Measures:
  • 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 [ Time Frame: Week 4 ]
    To evaluate the change in the percentage and in the severity of neuropsychiatric symptoms compiled using the ACTG adverse effects scale.
  • 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 [ Time Frame: Week 4 ]
    To evaluate the change in the percentage and in the severity of neuropsychiatric symptoms compiled using the pittsburgh sleep quality index
  • 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 [ Time Frame: Week 4 ]
    To evaluate the change in the percentage and in the severity of neuropsychiatric symptoms compiled using the hospital anxiety and depression scale.
  • 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 [ Time Frame: Week 24 after the switching ]
    To evaluate the change in global neurocognitive function (global deficit score) and cognitive domains (T-scores) in the volumes of the different structures of the brain using MRI volumetric techniques; the change in levels of neuronal integrity estimated by determining N-acetylaspartate levels in the structures of the frontal lobe and the basal ganglia using spectroscopy.
  • 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 [ Time Frame: Week 24 after the switching ]
    To evaluate the change in global neurocognitive function (global deficit score) and cognitive domains (T-scores) in the volumes of the different structures of the brain using MRI volumetric techniques; the change in the levels of white matter integrity estimated using the diffusion tensor imaging MRI technique.
  • 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 [ Time Frame: Week 24 after the switching ]
    To evaluate the change in global neurocognitive function (global deficit score) and cognitive domains (T-scores) in the volumes of the different structures of the brain using MRI volumetric techniques; the change in the levels of brain inflammation estimated by determining the levels of choline and myo-inositol in the structures of the frontal lobe and basal ganglia using spectroscopy.
  • Percentages of virologic failure [ Time Frame: Week 24 after the switching ]
    To evaluate the percentages of virologic failure after switching antiretroviral therapy from DTG/3TC/ABC to ELV/COBI/FTC/TAF

Estimated Enrollment: 64
Study Start Date: September 1, 2017
Estimated Study Completion Date: December 1, 2018
Estimated Primary Completion Date: June 1, 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: Arm 1
Patients who postpone switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF four weeks:
Drug: DTG/3TC/ABC + ELV/COBI/FTC/TAF

Patients continuing on treatment with DTG/3TC/ABC after the randomization for 4 weeks, and then switch to ELV/COBI/FTC/TAF for 24 weeks

Experimental: Arm 2
Patients who switch from DTG/3TC/ABC to ELV/COBI/FTC/TAF during the baseline visit
Drug: ELV/COBI/FTC/TAF

Treatment with ELV/COBI/FTC/TAF during 24 weeks since randomized.

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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03067285

Locations

Spain
Hospital Puerta de Hierro Not yet recruiting
Majadahonda, Madrid, Spain
Contact: Alfonso Angel-Moreno Maroto
Hospital Fundación Jimenez Díaz Not yet recruiting
Madrid, Spain
Contact: Alfonso Cabello, MD
Hospital Ramón y Cajal Not yet recruiting
Madrid, Spain
Contact: Mª Jesús Vivancos, MD
Hospital Univ. Infanta Leonor Not yet recruiting
Madrid, Spain
Contact: Pablo Ryan, MD
Hospital Univ. La Princesa Not yet recruiting
Madrid, Spain
Contact: Ignacio de los santos, MD
Hospital Universitario La Paz Not yet recruiting
Madrid, Spain
Contact: Ignacio Perez valero, MD

Sponsors and Collaborators

Fundacion SEIMC-GESIDA
More Information

More Information


Responsible Party: Fundacion SEIMC-GESIDA  
ClinicalTrials.gov Identifier: NCT03067285   History of Changes  
Other Study ID Numbers: GESIDA 9016  
Study First Received: February 14, 2017  
Last Updated: July 31, 2017  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
HIV Infections
Neurotoxicity Syndromes
Tenofovir
Lamivudine
Emtricitabine
Abacavir
Dolutegravir
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Cobicistat

ClinicalTrials.gov processed this data on November 22, 2017
This information is provided by ClinicalTrials.gov.