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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)

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ClinicalTrials.gov Identifier: NCT03067285
Recruitment Status : Completed
First Posted : March 1, 2017
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA

Tracking Information
First Submitted Date  ICMJE February 14, 2017
First Posted Date  ICMJE March 1, 2017
Last Update Posted Date August 27, 2019
Actual Study Start Date  ICMJE September 8, 2017
Actual Primary Completion Date April 23, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2017)
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, the Pittsburg sleep quality index and the hospital anxiety and depression scale.
Change History Complete list of historical versions of study NCT03067285 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2017)
  • 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, the Pittsburg sleep quality index and 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; the change in the levels of white matter integrity estimated using the diffusion tensor imaging MRI technique; and 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Drug: ELV/COBI/FTC/TAF
    Treatment with ELV/COBI/FTC/TAF during 24 weeks since randomized.
  • 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
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Patients who postpone switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF four weeks:
    Intervention: Drug: DTG/3TC/ABC + ELV/COBI/FTC/TAF
  • Experimental: Arm 2
    Patients who switch from DTG/3TC/ABC to ELV/COBI/FTC/TAF during the baseline visit
    Intervention: Drug: ELV/COBI/FTC/TAF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2019)
39
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2017)
64
Actual Study Completion Date  ICMJE April 23, 2019
Actual Primary Completion Date April 23, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03067285
Other Study ID Numbers  ICMJE GESIDA 9016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fundacion SEIMC-GESIDA
Study Sponsor  ICMJE Fundacion SEIMC-GESIDA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fundacion SEIMC-GESIDA
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP