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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 : Recruiting
First Posted : March 1, 2017
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: ELV/COBI/FTC/TAF Drug: DTG/3TC/ABC + ELV/COBI/FTC/TAF Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
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
Actual Study Start Date : September 8, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Lamivudine

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


  2. 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.

  3. 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 :
  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03067285


Locations
Spain
Hospital Puerta de Hierro Recruiting
Majadahonda, Madrid, Spain
Contact: Alfonso Angel-Moreno Maroto    911 916 112    alfangel22@hotmail.com   
Hospital Clínico San Carlos Not yet recruiting
Madrid, Spain
Contact: Mª Jesus Tellez, MD    913303538    mtellez.hcsc@salud.madrid.org   
Hospital Fundación Jimenez Díaz Recruiting
Madrid, Spain
Contact: Alfonso Cabello, MD    0031915504800 ext 4055    acabello@fjd.es   
Hospital Ramón y Cajal Recruiting
Madrid, Spain
Contact: Mª Jesús Vivancos, MD    913368672    mjesus.vivancos@gmail.com   
Hospital Univ. Infanta Leonor Recruiting
Madrid, Spain
Contact: Pablo Ryan, MD    911918281    pabloryan@gmail.com   
Hospital Univ. La Princesa Recruiting
Madrid, Spain
Contact: Ignacio de los santos, MD    0034915204014    isantosg@hotmail.com   
Hospital Universitario La Paz Recruiting
Madrid, Spain
Contact: Ignacio Perez valero, MD    0034917277000 ext 42132    ignacioperezvalero@gmail.com   
Sponsors and Collaborators
Fundacion SEIMC-GESIDA

Responsible Party: Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier: NCT03067285     History of Changes
Other Study ID Numbers: GESIDA 9016
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Tenofovir
Lamivudine
Emtricitabine
Dolutegravir
Abacavir
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Cobicistat
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
HIV Integrase Inhibitors
Integrase Inhibitors