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A Clinical Trial to Evaluate the Reversibility of Abacavir/Lamivudine/Dolutegravir CNS-Related Neurotoxicity After Switching to Tenofovir/Alafenamide/Emtricitabine/Darunavir/Cobicistat (TAF/FTC/DRV/c) (DETOX)

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ClinicalTrials.gov Identifier: NCT03685500
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Janssen-Cilag, S.A.
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA

Brief Summary:
A phase IV, multicentre, randomised, open-label, pilot clinical trial to evaluate the Reversibility of abacavir/lamivudine/dolutegravir ( ABC/3TC/DTG) CNS-Related Neurotoxicity After Switching to tenofovir alafenamide/emtricitabine/darunavir/cobicistat (TAF/FTC/DRV/c)

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Symtuza® (TAF/FTC/DRV/c) Drug: ABC/3TC/DTG + Symtuza® (TAF/FTC/DRV/c) Phase 4

Detailed Description:
The investigators estimate that 55 participants will need to be included per group, 110 patients in total, to demonstrate the benefit of switching ABC/3TC/DTG to TAF/FTC/DRV/c

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A phase IV, multicentre, randomised, open-label, pilot clinical trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV, Open Label, Randomized, Clinical Trial to Evaluate the Reversibility of Abacavir/Lamivudine/Dolutegravir CNS-Related Neurotoxicity After Switching to Tenofovir Alafenamide/Emtricitabine/Darunavir/Cobicistat
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Arm 1
Patients who postpone switching from ABC/3TC/DTG to Symtuza® (TAF/FTC/DRV/c) four weeks
Drug: ABC/3TC/DTG + Symtuza® (TAF/FTC/DRV/c)
Patients continuing on treatment with DTG/3TC/ABC after the randomization for 4 weeks, and then switch to TAF/FTC/DRV/c for 8 weeks

Experimental: Arm 2
Patients who switch from ABC/3TC/DTG to Symtuza® (TAF/FTC/DRV/c) during the baseline visit
Drug: Symtuza® (TAF/FTC/DRV/c)
Treatment with TAF/FTC/DRV/c during 8 weeks since randomized




Primary Outcome Measures :
  1. Proportion of patients who self-reported insomnia, between HIV-suppressed patients who continue ABC/3TC/DTG and those who switched to TAF/FTC/DRV/c [ 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 (PSQI). The PSQI contains 19 questions in total. These questions are combined to form seven areas with their corresponding score, each of which shows a range between 0 and 3 points. In all cases, a score of "0" indicates ease, while a score of 3 indicates medium difficulty, within their respective area. The score of the seven areas is finally added for a global score, which ranges from 0 to 21 points. "0" indicates ease of sleep and "21" severe difficulty in all areas


Secondary Outcome Measures :
  1. Changes in the severity of neuropsychiatric symptoms, between HIV-suppressed patients who continue ABC/3TC/DTG and those who switched to TAF/FTC/DRV/c [ 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. Researchers will specifically ask the patient about eleven adverse effects at each visit. Each adverse effect will be documented and graduated, according to the criteria established in the "AIDS Clinical Trials Group (ACTG) Division of AIDS scale (2014)". Each adverse effect will be assigned a score between 0 and 3 points. The Score will include the individual scores for each of the eleven adverse effects collected, as well as the sum of all the individual scores presented by each patient at each study visit

  2. Changes in the severity of neuropsychiatric symptoms, between HIV-suppressed patients who continue ABC/3TC/DTG and those who switched to TAF/FTC/DRV/c [ 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 hospital anxiety and depression scale. The scale includes 14 questions to evaluate the presence of depressive symptoms during the last week. Each question contains four answers with score between 0 and 3 points. To obtain the results of the questionnaire, the researcher must add the score obtained in the 7 questions of anxiety on the one hand and the 7 questions of depression on the other

  3. Changes in the severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c [ Time Frame: Week 4 and 8 after switching to TAF/FTC/DRV/c ]
    To evaluate the change in the percentage and in the severity of neuropsychiatric symptoms compiled using the ACTG adverse effects scale

  4. Changes in the severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c [ Time Frame: Week 4 and 8 after switching to TAF/FTC/DRV/c ]
    To evaluate the change in the percentage and in the severity of neuropsychiatric symptoms compiled using the Pittsburg sleep quality index (PSQI)

  5. Proportion and severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c [ Time Frame: Week 4 and 8 after switching to TAF/FTC/DRV/c ]
    To evaluate the change in the percentage and in the severity of neuropsychiatric symptoms compiled using the hospital anxiety and depression scale.

  6. Percentage of virologic failure after switching antiretroviral therapy from ABC/3TC/DTG to TAF/FTC/DRV/c [ Time Frame: Week 8 after switching to TAF/FTC/DRV/c ]
    Virologic failure is defined as the presence of two consecutive HIV viral loads ≥ 50 copies/mL.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient ≥ 18 years of age diagnosed with HIV using conventional serology techniques.
  • Current antiretroviral therapy with ABC/3TC/DTG for at least 4 weeks.
  • HIV viral load < 50 copies/mL for at least 24 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.
  • A positive screening test for sleep disorders detected using the sleep quality index (Pittsburgh ).

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 TAF/FTC/DRV/c.
  • 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.
  • 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.
  • Patient with documented intolerance or hypersensitivity to the study medication, or who has a contraindication to use it, according to the technical data sheet

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): NCT03685500


Locations
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Spain
Hospital Puerta de Hierro Not yet recruiting
Majadahonda, Madrid, Spain
Contact: Alfonso Angel-Moreno Maroto    911 916 112    alfangel22@hotmail.com   
Hospital Univ. 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: María Lagarde, MD    +34 917792853    estudioshiv12@gmail.com   
H. Univ. Príncipe de Asturias Recruiting
Madrid, Spain
Contact: María Novella, MD    +34 918878100    mnovellam@gmail.com   
Hospital Fundación Jimenez Diaz Recruiting
Madrid, Spain
Contact: Alfonso Cabello    915504800 ext 4055    acabello@fjd.es   
Hospital Infanta Leonor Recruiting
Madrid, Spain
Contact: Jesus Troya, MD    911918281    jestrogar@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
Janssen-Cilag, S.A.

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Responsible Party: Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier: NCT03685500    
Other Study ID Numbers: GESIDA 10418
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neurotoxicity Syndromes
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Emtricitabine
Darunavir
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 Protease Inhibitors
Protease Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors